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Irish Statutory Instruments |
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You are here: BAILII >> Databases >> Irish Statutory Instruments >> European Union (Lifts and Safety Components for Lifts) Regulations S.I. No. 232/2017 URL: http://www.bailii.org/ie/legis/num_reg/2017/0232.html |
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ARRANGEMENT OF REGULATIONS | ||
PART 1 | ||
CITATION, INTERPRETATION | ||
1. Citation. | ||
2. Interpretation. | ||
3. Designation. | ||
4. Application. | ||
5. Making available on the market and putting into service. | ||
6. Essential health and safety requirements. | ||
7. Buildings or constructions in which lifts are installed and prior approval for installation of reduced headroom lifts. | ||
PART 2 | ||
OBLIGATIONS OF ECONOMIC OPERATORS | ||
8. Obligations of installers. | ||
9. Obligations of manufacturers. | ||
10. Authorised representatives. | ||
11. Obligations of importers. | ||
12. Obligations of distributors. | ||
13. Cases in which obligations of manufacturers apply to importers and distributors. | ||
14. Identification of economic operators. | ||
PART 3 | ||
CONFORMITY OF PRODUCTS | ||
15. Presumption of conformity on the basis of harmonised standards. | ||
16. Conformity assessment procedures for safety components. | ||
17. Conformity assessment procedures for lifts. | ||
18. EU declaration of conformity. | ||
19. General principles of the CE marking. | ||
20. Rules and conditions for affixing the CE marking and other markings. | ||
PART 4 | ||
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES | ||
21. Notified bodies. | ||
22. Application for notification by conformity assessment bodies. | ||
23. Notification of conformity assessment bodies. | ||
24. Changes to notifications. | ||
25. Subsidiaries of and subcontracting by notified bodies. | ||
26. Operational obligations of notified bodies. | ||
27. Appeals against decisions of notified bodies. | ||
28. Information obligation on notified bodies. | ||
PART 5 | ||
MARKET SURVEILLANCE, SAFEGUARD PROCEDURE | ||
29. Market surveillance. | ||
30. Procedure for dealing with products presenting a risk at national level. | ||
31. Safeguard procedure. | ||
32. Compliant lifts or safety components which present a risk. | ||
33. Formal non-compliance. | ||
PART 6 | ||
POWERS OF THE MARKET SURVEILLANCE AUTHORITY | ||
34. General. | ||
35. Powers of inspectors. | ||
36. Measures entailing refusal or restriction. | ||
37. Contravention notice. | ||
38. Appeal against contravention notice. | ||
39. Prohibition notice. | ||
40. Appeal against prohibition notice. | ||
41. Order of the High Court. | ||
42. Information notice. | ||
43. Service of notifications. | ||
44. Sharing information on the application of the Directive. | ||
PART 7 | ||
OFFENCES AND PENALTIES | ||
45. Offences. | ||
46. Penalties. | ||
47. Offences by bodies corporate. | ||
48. Prosecution of offences. | ||
PART 8 | ||
MISCELLANEOUS | ||
49. Appeal to Circuit Court from certain orders of District Court. | ||
50. Notice or direction to be in writing. | ||
51. Immunity. | ||
52. Indemnification. | ||
53. Restrictions on the disclosure of information. | ||
54. Transitional. | ||
55. Revocation. | ||
SCHEDULE 1 | ||
TEXT OF ANNEX I TO THE DIRECTIVE | ||
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS. | ||
SCHEDULE 2 | ||
TEXT OF ANNEX II TO THE DIRECTIVE | ||
A. Content of the EU declaration of conformity for safety components for lifts, B. Content of the EU declaration of conformity for lifts. | ||
SCHEDULE 3 | ||
TEXT OF ANNEX III TO THE DIRECTIVE | ||
LIST OF SAFETY COMPONENTS FOR LIFTS. | ||
SCHEDULE 4 | ||
TEXT OF ANNEX IV TO THE DIRECTIVE | ||
EU-TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS (MODULE B). | ||
SCHEDULE 5 | ||
TEXT OF ANNEX V TO THE DIRECTIVE | ||
FINAL INSPECTION FOR LIFTS. | ||
SCHEDULE 6 | ||
TEXT OF ANNEX VI TO THE DIRECTIVE | ||
CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS (MODULE E). | ||
SCHEDULE 7 | ||
TEXT OF ANNEX VII TO THE DIRECTIVE | ||
CONFORMITY BASED ON FULL QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS (MODULE H). | ||
SCHEDULE 8 | ||
TEXT OF ANNEX VIII TO THE DIRECTIVE | ||
CONFORMITY BASED ON UNIT VERIFICATION FOR LIFTS (MODULE G). | ||
SCHEDULE 9 | ||
TEXT OF ANNEX IX TO THE DIRECTIVE | ||
CONFORMITY TO TYPE WITH RANDOM CHECKING FOR SAFETY COMPONENTS FOR LIFTS (MODULE C 2). | ||
SCHEDULE 10 | ||
TEXT OF ANNEX X TO THE DIRECTIVE | ||
CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR LIFTS (MODULE E). | ||
SCHEDULE 11 | ||
TEXT OF ANNEX XI TO THE DIRECTIVE | ||
CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION FOR LIFTS (MODULE H1). | ||
SCHEDULE 12 | ||
TEXT OF ANNEX XII TO THE DIRECTIVE | ||
CONFORMITY TO TYPE BASED ON PRODUCTION QUALITY ASSURANCE FOR LIFTS (MODULE D). | ||
SCHEDULE 13 | ||
TEXT OF ANNEX XIV TO THE DIRECTIVE | ||
CORRELATION TABLE. | ||
S.I. No. 232 of 2017 | ||
EUROPEAN UNION (LIFTS AND SAFETY COMPONENTS FOR LIFTS) REGULATIONS 2017 | ||
Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 2nd June, 2017. | ||
I, MARY MITCHELL O’CONNOR, Minister for Jobs, Enterprise and Innovation, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) (as amended by section 2 of the European Communities Act 2007 (No. 18 of 2007)) and for the purpose of giving effect to Directive 2014/33/EU of the European Parliament and of the Council of 26 February 20141 and of giving further effect to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 20082 , hereby make the following regulations: | ||
PART 1 | ||
CITATION, INTERPRETATION | ||
Citation | ||
1. (1) These Regulations may be cited as the European Union (Lifts and Safety Components for Lifts) Regulations 2017. | ||
(2) These Regulations (other than Regulation 7(3)) come into operation on the day of their making. | ||
(3) Regulation 7(3) comes into operation from 1 November 2017. | ||
Interpretation | ||
2. (1) In these Regulations— | ||
“accreditation” has the meaning assigned to it in point 10 of Article 2 of Regulation (EC) No. 765/2008; | ||
“Act of 2005” means the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005); | ||
“authorised representative” means any natural or legal person established within the European Economic Area who has received a written mandate from an installer or a manufacturer to act on its behalf in relation to specified tasks; | ||
“carrier” means a part of the lift by which persons or goods or both are supported in order to be lifted or lowered; | ||
“CE marking” means a marking by which the installer or the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing; | ||
“Companies Acts” means the Companies Act 2014 (No. 38 of 2014) or, as the context may require, the legislation repealed by s. 4 of the Companies Act 2014 ; | ||
“competent authority” means— | ||
(a) in the State, the market surveillance authority, or | ||
(b) in another Member State, any authority or body to whom functions have been assigned as a competent authority or a market surveillance authority, for the purposes of the Directive; | ||
“conformity assessment” means the process demonstrating whether the essential health and safety requirements of the Directive or these Regulations relating to a product have been fulfilled; | ||
“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection; | ||
“contravention notice” means the notice provided for in Regulation 37; | ||
“Coroners Acts 1962 and 2005” means the Coroners Act 1962 (No. 9 of 1962) as amended by the Coroners (Amendment) Act 2005 (No. 33 of 2005); | ||
“Directive” means Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014; | ||
“Directive 95/16/EC” means European Parliament and Council Directive 95/16/EC of 29 June 19953 | ||
“distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a safety component available on the market; | ||
“economic operator” means an installer, manufacturer, authorised representative, importer or distributor; | ||
“EU declaration of conformity” means a declaration drawn up in accordance with Regulation 18; | ||
“harmonised standard” has the meaning assigned to it in point (c) of point 1 of Article 2 of Regulation (EU) No. 1025/2012 of the European Parliament and of the Council of 25 October 20124 | ||
“importer” means any natural or legal person established within the European Economic Area who places a safety component from a third country on the market of the European Economic Area; | ||
“impossible” means, in the context of prior approval for reduced headroom lifts, that it is not possible using up to date engineering practice to install the required refuge space without having to modify the existing foundations of the building or breach requirements related to heritage preservation; | ||
“information notice” means the notice provided for in Regulation 42; | ||
“inspector” has the meaning assigned to it in Regulation 34(2); | ||
“installer” means the natural or legal person who takes responsibility for the design, manufacture, installation and placing on the market of the lift; | ||
“Irish National Accreditation Board” means the national body with responsibility for the accreditation of laboratories, certification bodies and inspection bodies, and notified to the European Commission as being the sole accreditation body for Ireland in line with Regulation (EC) No 765/2008; | ||
“lift” means a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, or a lifting appliance moving along a fixed course even where it does not move along rigid guides; | ||
“making available on the market” means any supply of a safety component for distribution or use on the market of the European Economic Area in the course of a commercial activity, whether in return for payment or free of charge; | ||
“manufacturer” means any natural or legal person who manufactures a safety component or has a safety component designed or manufactured, and markets it under its name or trademark; | ||
“market surveillance authority” means the authority designated as a market surveillance authority under Regulation 3; | ||
“Member State” means a state which is a contracting party to the Agreement on the European Economic Area signed in Oporto on 2 May 1992; | ||
“Minister” means the Minister for Jobs, Enterprise and Innovation; | ||
“model lift” means a representative lift whose technical documentation shows the way in which the essential health and safety requirements set out in Annex I, the text of which is set out in Schedule 1 to these Regulations, will be met for lifts which conform to the model lift defined by objective parameters and which uses identical safety components; | ||
“notified body” means— | ||
(a) in the State, a conformity assessment body notified by the notifying authority pursuant to Regulation 21, and | ||
(b) in another Member State, a conformity assessment body notified by the relevant notifying authority pursuant to the Directive; | ||
“notifying authority” means the authority designated as the notifying authority in the State under Regulation 3 and in another Member State the authority designated as notifying authority pursuant to the Directive; | ||
“Official Journal” means the Official Journal of the European Union; | ||
“person in charge” means, in relation to a place— | ||
(a) the person under whose direction and control the activities at that place are being conducted, or | ||
(b) the person whom the inspector has reasonable grounds for believing is in control of that place; | ||
“placing on the market” means— | ||
(a) the first making available on the market of a safety component, or | ||
(b) the supply of a lift for use on the market of the European Economic Area in the course of a commercial activity, whether in return for payment or free of charge; | ||
“premises of an economic operator” means any premises owned or being used by an economic operator; | ||
“prohibition notice” means the notice provided for in Regulation 39; | ||
“product” means any lift or safety component; | ||
“putting into service” means the first use of a product by its user; | ||
“recall” in relation to a lift means any measure aimed at achieving the dismantling and safe disposal of a lift, and in relation to a safety component means any measure aimed at achieving the return of a safety component that has already been made available to the installer or to the end-user; | ||
“Regulations of 1998” means means the European Communities (Lifts) Regulations ( S.I. No. 246 of 1998 ) as amended by the European Communities (Lifts) (Amendment) Regulations 2008 ( S.I. No. 406 of 2008 ); | ||
“Regulation (EC) No. 765/2008” means Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the equirements or accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 993/93; | ||
“safety component” means a safety component for a lift; | ||
“technical specification” means a document that prescribes technical requirements to be fulfilled by a product; | ||
“Union harmonisation legislation” means any European Union legislation harmonising the conditions for the marketing of products; | ||
“withdrawal” means any measure aimed at preventing a safety component in the supply chain from being made available on the market. | ||
(2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive. | ||
(3) References to the repealed Directive 95/16/EC shall be construed in existing laws, regulations and administrative provisions of the State as references to the Directive and shall be read in accordance with the correlation table in Annex XIV to the Directive, the text of which is set out in Schedule 13 to these Regulations. | ||
Designation | ||
3. For the purposes of the Directive and these Regulations— | ||
(a) the Health and Safety Authority is designated as the market surveillance authority, and | ||
(b) the Minister is designated as the notifying authority. | ||
Application | ||
4. (1) Subject to paragraphs (2) and (3), these Regulations apply to— | ||
(a) lifts permanently serving buildings and constructions and intended for the transport of— | ||
(i) persons, | ||
(ii) persons and goods, | ||
(iii) goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier, and | ||
(b) the safety components listed in Schedule 3 for use in the lifts referred to in subparagraph (a) of this Regulation. | ||
(2) These Regulations do not apply to— | ||
(a) lifting appliances whose speed is not greater than 0.15 m/s, | ||
(b) construction site hoists, | ||
(c) cableways, including funicular railways, | ||
(d) lifts specially designed and constructed for military or police purposes, | ||
(e) lifting appliances from which work can be carried out, | ||
(f) mine winding gear, | ||
(g) lifting appliances intended for lifting performers during artistic performances, | ||
(h) lifting appliances fitted in means of transport, | ||
(i) lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery, | ||
(j) rack and pinion trains, and | ||
(k) escalators and mechanical walkways. | ||
(3) In a case where for lifts or safety components, the risks referred to in these Regulations are wholly or partly covered by specific European Union law, these Regulations do not apply or shall cease to apply in the case of such lifts or safety components and such risks as from the application of that specific European Union law. | ||
Making available on the market and putting into service | ||
5. (1) Subject to paragraph (2), a person shall not— | ||
(a) place on the market or put into service any lift unless it complies with the Directive or these Regulations when properly installed and maintained and used for its intended purpose, or | ||
(b) make available on the market or put into service any safety component unless it complies with the Directive or these Regulations when properly incorporated and maintained and used for its intended purpose. | ||
(2) Paragraph (1) shall not prevent a person from showing a lift or a safety component which does not comply with the Directive or these Regulations at a trade fair, exhibition or demonstration, provided that— | ||
(a) a visible sign clearly indicates that the lift or safety component does not comply with the Directive or these Regulations and that it will not be placed or made available on the market until they have been brought into conformity, and | ||
(b) adequate safety measures are taken during demonstrations to ensure the protection of persons. | ||
Essential health and safety requirements | ||
6. (1) Lifts shall satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations. | ||
(2) Safety components shall satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations and enable the lifts in which they are incorporated to satisfy those requirements. | ||
Buildings or constructions in which lifts are installed and prior approval for installation of reduced headroom lifts | ||
7. (1) A person responsible for work on a building or construction and the installer shall provide each other with the necessary information and take the appropriate steps in order to ensure the proper operation and safe use of a lift. | ||
(2) A person shall not install or cause to be installed piping, wiring or fittings in a lift shaft other than the piping, wiring or fittings necessary for the operation and safety of the lift. | ||
(3) Notwithstanding point 2.2 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, and in light of the third sentence thereto, where it is impossible to have a refuge or free space beyond the extreme positions of a lift, a person may commence the installation of the lift with reduced headroom after he or she has sought, and been granted, written prior approval from the Minister. | ||
PART 2 | ||
OBLIGATIONS OF ECONOMIC OPERATORS | ||
Obligations of installers | ||
8. An installer shall— | ||
(a) ensure that a lift placed on the market by the installer has been designed, manufactured, installed and tested in accordance with the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, | ||
(b) draw up the technical documentation and carry out, or have carried out, the relevant conformity assessment procedure referred to in Regulation 17, | ||
(c) in a case where compliance with the applicable essential health and safety requirements has been demonstrated by the conformity assessment procedure carried out under paragraph (b)— | ||
(i) draw up an EU declaration of conformity, | ||
(ii) ensure that the EU declaration of conformity accompanies the lift, and | ||
(iii) affix a CE marking to the lift in accordance with Regulation 20, | ||
(d) retain the technical documentation, the EU declaration of conformity and, where applicable, the approval decision(s) for 10 years after the lift has been placed on the market, | ||
(e) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by the lift and in order to protect the health and safety of consumers, investigate and, if necessary, keep a register of complaints and of non-conforming lifts, | ||
(f) ensure that the lift bears a type, batch or serial number or other element allowing its identification, | ||
(g) indicate on the lift, in a language easily understood by end-users and the market surveillance authority, the installer’s name, registered trade name or registered trade mark and the postal address at which the installer can be contacted, which address shall indicate a single point at which the installer can be contacted, | ||
(h) ensure that the lift is accompanied by the instructions referred to in point 6.2 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by end-users and that such instructions, as well as any labelling, are clear, understandable and intelligible, | ||
(i) in the case of a lift which the installer has placed on the market and which the installer considers or has reason to believe is not in conformity with the Directive or these Regulations— | ||
(i) immediately take the corrective measures necessary to bring that lift into conformity with the Directive or these Regulations, and | ||
(ii) where the lift presents a risk, immediately inform the competent authorities of the Member States in which the installer placed the lift on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken, and | ||
(j) further to a reasoned request from a competent authority in respect of a lift which the installer has made placed on the market— | ||
(i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the lift with the Directive or these Regulations, in a language which can be easily understood by that authority, and | ||
(ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by lifts placed on the market by the installer. | ||
Obligations of manufacturers | ||
9. A manufacturer shall— | ||
(a) ensure that safety components placed on the market by the manufacturer have been designed and manufactured so as to satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations and that they enable lifts in which they are incorporated to satisfy those requirements, | ||
(b) draw up the required technical documentation and carry out, or have carried out, the relevant conformity assessment procedure referred to in Regulation 16, | ||
(c) in a case where compliance of a safety component with the applicable essential health and safety requirements has been demonstrated by the conformity assessment procedure carried out under paragraph (b)— | ||
(i) draw up an EU declaration of conformity in accordance with Regulation 18, | ||
(ii) ensure that the EU declaration of conformity accompanies the safety component, and | ||
(iii) affix the CE marking in accordance with Regulation 20, | ||
(d) retain the technical documentation, the EU declaration of conformity and, where applicable, the approval decision(s) for 10 years after the safety component has been placed on the market, | ||
(e) ensure that procedures are in place for series production to remain in conformity with the Directive or these Regulations and that changes in product design or characteristics, and changes in the harmonised standards referred to in Regulation 15 or in other technical specifications by reference to which conformity of a safety component is declared, are adequately taken into account, | ||
(f) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by a safety component and in order to protect the health and safety of consumers— | ||
(i) carry out sample testing of safety components made available on the market, | ||
(ii) investigate, and, if necessary, keep a register of complaints, of non-conforming safety components and recalls of safety components, and | ||
(iii) keep distributors and installers informed of any such monitoring, | ||
(g) ensure that safety components which the manufacturer has placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the safety component does not allow it, that the required information is provided on the label referred to in Regulation 20(2), | ||
(h) indicate on the safety component, in a language easily understood by end-users and competent authorities, the manufacturer’s name, registered trade name or registered trade mark and the postal address at which they can be contacted, which address shall indicate a single point of contact or, where it is not possible to do so on the component, on the label referred to in Regulation 20(2), | ||
(i) ensure that the safety component is accompanied by the instructions referred to in point 6.1 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by end-users and that such instructions, as well as any labelling, are clear, understandable and intelligible, | ||
(j) in the case of a safety component which the manufacturer has placed on the market and which the manufacturer considers or has reason to believe is not in conformity with the Directive or these Regulations— | ||
(i) immediately take the corrective measures necessary to bring that safety component into conformity, to withdraw it or recall it, if appropriate, and | ||
(ii) where the safety component presents a risk, immediately inform the competent authorities of the Member States in which the manufacturer made the component available on the market, giving details, in particular, of the non-conformity and of any corrective measures taken, | ||
and | ||
(k) further to a reasoned request from a competent authority in respect of a component which the manufacturer has placed on the market— | ||
(i) provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the safety component with the Directive or these Regulations, in a language easily understood by that authority, and | ||
(ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by safety components placed on the market by the manufacturer. | ||
Authorised representatives | ||
10. (1) A manufacturer or an installer may, by a written mandate, appoint an authorised representative for the purposes of the Directive or these Regulations. | ||
(2) The obligations laid down in Regulations 8(a) and 9(a) and the obligation to draw up technical documentation referred to in Regulation 8(b) and 9(b), shall not form part of the mandate of an authorised representative appointed under paragraph (1). | ||
(3) An authorised representative appointed under paragraph (1) shall perform the tasks specified in the mandate received from the manufacturer or installer which shall, at least, allow the authorised representative to— | ||
(a) keep the EU declaration of conformity and, where applicable, the approval decision(s) relating to the manufacturer’s or installer’s quality system, and the technical documentation at the disposal of competent authorities for 10 years after a safety component or lift has been placed on the market by the manufacturer or installer, | ||
(b) further to a reasoned request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the safety component or lift, and | ||
(c) cooperate with a competent authority, at its request, on any action taken to eliminate the risks posed by the safety component or lift covered by the authorised representative’s mandate. | ||
Obligations of importers | ||
11. (1) An importer shall not place a safety component on the market unless it complies with the Directive and these Regulations. | ||
(2) An importer shall— | ||
(a) before placing a safety component on the market, ensure that— | ||
(i) the appropriate conformity assessment procedure referred to in Regulation 16 has been carried out by the manufacturer, | ||
(ii) the manufacturer has drawn up the technical documentation, | ||
(iii) the safety component bears the CE marking and is accompanied by the EU declaration of conformity and the required documents, and | ||
(iv) the manufacturer has complied with the requirements set out in Regulation 9(g) and (h), | ||
(b) in a case where the importer considers or has reason to believe that a safety component is not in conformity with Regulation 6(2)— | ||
(i) not place the safety component on the market until it has been brought into conformity, and | ||
(ii) where the safety component presents a risk, inform the manufacturer and the competent authorities of the Member States to that effect, | ||
(c) indicate on the safety component, in a language which can be easily understood by end-users and competent authorities, or where it is not possible to do so on the component, on its packaging or in a document accompanying it, the importer’s name, registered trade name or registered trade mark and the postal address at which the importer can be contacted, | ||
(d) ensure that the safety component is accompanied by the instructions referred to in point 6.1 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by consumers and other end-users, | ||
(e) ensure that, while the safety component is under the importer’s responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements referred to in Regulation 6(2), | ||
(f) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by the safety component and in order to protect the health and safety of consumers, the importer shall— | ||
(i) carry out sample testing, | ||
(ii) investigate, and, if necessary, keep a register of complaints of, non-conforming safety components and recalls of safety components, and | ||
(iii) keep distributors and installers informed of any such monitoring, | ||
(g) in a case where the importer considers or has reason to believe that a safety component which the importer has placed on the market is not in conformity with the Directive or these Regulations— | ||
(i) immediately take the corrective measures necessary to bring that safety component into conformity, to withdraw it or recall it, if appropriate, and | ||
(ii) where the safety component presents a risk, immediately inform the competent authorities of the Member States in which the importer made the safety components available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken, | ||
(h) for 10 years after the safety component has been placed on the market by the importer— | ||
(i) keep a copy of the EU declaration of conformity and, where applicable, of the approval decision(s) at the disposal of competent authorities, and | ||
(ii) ensure that the technical documentation can be made available to those authorities, upon request, | ||
and | ||
(i) further to a reasoned request from a competent authority in respect of a component which the importer has made available on the market— | ||
(i) provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the safety component, in a language which can be easily understood by that authority, and | ||
(ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the safety component which the importer has placed on the market. | ||
Obligations of distributors | ||
12. A distributor shall— | ||
(a) act with due care in relation to the requirements of the Directive or these Regulations when making a safety component available on the market, | ||
(b) before making the safety component available on the market, verify that— | ||
(i) the component bears the CE marking, | ||
(ii) the component is accompanied by the EU declaration of conformity and by the required documents, | ||
(iii) the component is accompanied by the instructions referred to in point 6.1 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by end-users, and | ||
(iv) the manufacturer and the importer have complied with the requirements set out in Regulation 9(g) and (h), and Regulation 11(2)(c), respectively, | ||
(c) in a case where the distributor considers or has reason to believe that a safety component is not in conformity with Regulation 6(2)— | ||
(i) not make the component available on the market until it has been brought into conformity, and | ||
(ii) where the component presents a risk, inform the manufacturer or the importer to that effect as well as the competent authorities of the Member States, | ||
(d) ensure that, while the safety component is under the distributor’s responsibility, its storage or transport conditions do not jeopardise its compliance with Regulation 6(2), | ||
(e) in a case where the distributor considers, or has reason to believe, that a safety component which the distributor has made available on the market is not in conformity with the Directive or these Regulations— | ||
(i) make sure that the corrective measures necessary to bring that safety component into conformity, to withdraw it or recall it, if appropriate, are taken, and | ||
(ii) where the safety component presents a risk, immediately inform the competent authorities of the Member States in which the distributor made that component available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken, | ||
and | ||
(f) further to a reasoned request from a competent authority in respect of a component which the distributor has made available on the market— | ||
(i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the safety component, and | ||
(ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the safety component. | ||
Cases in which obligations of manufacturers apply to importers and distributors | ||
13. An importer or distributor shall be considered a manufacturer for the purposes of the Directive or these Regulations, and shall be subject to the obligations of the manufacturer under Regulation 9, where that importer or distributor— | ||
(a) places a safety component on the market under the importer or distributor’s name or trade mark, or | ||
(b) modifies a safety component already placed on the market in such a way that compliance with the Directive or these Regulations may be affected. | ||
Identification of economic operators | ||
14. An economic operator shall— | ||
(a) on request, identify to a competent authority any economic operator— | ||
(i) who has supplied the first named economic operator with a safety component, or | ||
(ii) to whom the first named economic operator has supplied a safety component, and | ||
(b) be able to present the information referred to in paragraph (a) for 10 years after the first named economic operator has been supplied with, or who has supplied, the safety component. | ||
PART 3 | ||
CONFORMITY OF PRODUCTS | ||
Presumption of conformity on the basis of harmonised standards | ||
15. Without prejudice to the powers of the State under Articles 38 and 40 of the Directive, a lift or safety component which is in conformity with harmonised standards, or part thereof, the references to which have been published in the Official Journal, shall be presumed to be in conformity with the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, covered by those standards, or parts thereof. | ||
Conformity assessment procedures for safety components | ||
16. Safety components shall be subject to one of the following conformity assessment procedures: | ||
(a) the model of the safety component shall be submitted for EU type examination set out in Annex IV Part A to the Directive, the text of which is set out in Schedule 4 to these Regulations and the conformity to type shall be ensured with random checking of the safety component set out in Annex IX to the Directive, the text of which is set out in Schedule 9 to these Regulations; | ||
(b) the model of the safety component shall be submitted for EU type examination set out in Annex IV Part A to the Directive, the text of which is set out in Schedule 4 to these Regulations and be subject to conformity to type based on product quality assurance in accordance with Annex VI to the Directive, the text of which is set out in Schedule 6 to these Regulations; or | ||
(c) conformity based on full quality assurance set out in Annex VII to the Directive, the text of which is set out in Schedule 7 to these Regulations. | ||
Conformity assessment procedures for lifts | ||
17. (1) Lifts shall be subject to one of the following conformity assessment procedures: | ||
(a) if they are designed and manufactured in accordance with a model lift that has undergone an EU-type examination set out in in Annex IV Part B to the Directive, the text of which is set out in Schedule 4 to these Regulations, the lifts shall be subject to— | ||
(i) final inspection for lifts set out in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations, | ||
(ii) conformity to type based on product quality assurance for lifts set out in Annex X to the Directive, the text of which is set out in Schedule 10 to these Regulations, or | ||
(iii) conformity to type based on production quality assurance for lifts set out in Annex XII to the Directive, the text of which is set out in Schedule 12 to these Regulations; | ||
(b) if they are designed and manufactured under a quality system approved in accordance with Annex XI to the Directive, the text of which is set out in Schedule 11 to these Regulations, the lifts shall be subject to— | ||
(i) final inspection for lifts set out in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations, | ||
(ii) conformity to type based on product quality assurance for lifts set out in Annex X to the Directive, the text of which is set out in Schedule 10 to these Regulations, or | ||
(iii) conformity to type based on production quality assurance for lifts set out in Annex XII to the Directive, the text of which is set out in Schedule 12 to these Regulations; | ||
(c) conformity based on unit verification for lifts set out in Annex VIII to the Directive, the text of which is set out in Schedule 8 to these Regulations; or | ||
(d) conformity based on full quality assurance plus design examination for lifts set out in Annex XI to the Directive, the text of which is set out in Schedule 11 to these Regulations. | ||
(2) In the cases referred to in paragraphs 1(a) and (b), where the person responsible for the design and manufacture of the lift and the person responsible for the installation and testing of the lift are not the same, the former shall supply to the latter all the necessary documents and information to enable the latter to ensure correct and safe installation and testing of the lift. | ||
(3) All permitted variations between the model lift and the lifts forming part of the lifts derived from the model lift shall be clearly specified (with maximum and minimum values) in the technical documentation. | ||
(4) By calculation or on the basis of design plans it is permitted to demonstrate the similarity of a range of equipment to satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations. | ||
EU declaration of conformity | ||
18. (1) An EU declaration of conformity for a lift or a safety component shall— | ||
(a) state that the fulfilment of the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, has been demonstrated, | ||
(b) have the model structure set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations, | ||
(c) contain the elements specified in the relevant Annexes V to XII to the Directive, the texts of which are set out in Schedules 5 to 12 of these Regulations, | ||
(d) be continuously updated, and | ||
(e) be translated into the language or the languages required by the Member State in which the lift or the safety component is placed or made available on the market. | ||
(2) Where a product is subject to more than one European Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such European Union acts and that declaration shall contain the identification of the European Union acts concerned including their publication references. | ||
(3) By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the safety component and the installer shall assume responsibility for the compliance of the lift with the requirements laid down in the Directive or these Regulations. | ||
General principles of the CE marking | ||
19. The CE marking when affixed to a lift or a safety component is subject to the general principles set out in Article 30 of Regulation (EC) No. 765/2008. | ||
Rules and conditions for affixing the CE marking and other markings | ||
20. (1) Subject to paragraph (2), before a lift or safety component is placed on the market, the CE marking shall be affixed visibly, legibly and indelibly to each lift car and to each safety component. | ||
(2) Where it is not possible to affix the CE marking to a safety component, before the component is placed on the market, the CE marking shall be affixed to a label inseparably attached to the component. | ||
(3) The CE marking on lifts shall be followed by the identification number of the notified body involved in any of the following conformity assessment procedures: | ||
(a) the final inspection referred to in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations; | ||
(b) unit verification, referred to in Annex VIII to the Directive, the text of which is set out in Schedule 8 to these Regulations; or | ||
(c) quality assurance referred to in Annexes X, XI or XII to the Directive, the texts of which are set out in Schedules 10, 11 and 12 of these Regulations. | ||
(4) The CE marking on safety components shall be followed by the identification number of the notified body involved in any of the following conformity assessment procedures: | ||
(a) product quality assurance referred to in Annex VI to the Directive, the text of which is set out in Schedule 6 to these Regulations; | ||
(b) full quality assurance referred to in Annex VII to the Directive, the text of which is set out in Schedule 7 to these Regulations; or | ||
(c) conformity to type with random checking for safety components referred to in Annex IX to the Directive, the text of which is set out in Schedule 9 to these Regulations. | ||
(5) The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or its authorised representative or by the installer or its authorised representative. | ||
(6) The CE marking and the identification number of the notified body may be followed by any other mark indicating a special risk or use. | ||
PART 4 | ||
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES | ||
Notified bodies | ||
21. (1) The notifying authority shall notify the European Commission and the other Member States of the conformity assessment bodies authorised under these Regulations to carry out third party conformity assessment tasks. | ||
(2) Only conformity assessment bodies which have been notified to the European Commission and other Member States in accordance with the Directive and these Regulations and against whom no objections are raised by the European Commission or other Member States within the time periods set down under Article 28(5) of the Directive, shall be notified bodies for the purposes of the Directive and these Regulations. | ||
Application for notification by conformity assessment bodies | ||
22. (1) A conformity assessment body seeking to become a notified body shall meet the requirements set down in paragraphs 2 to 11 of Article 24 of the Directive. | ||
(2) Without prejudice to paragraph (1), where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal, it shall be presumed to comply with the requirements set down in Article 24 of the Directive insofar as the applicable harmonised standards cover those requirements. | ||
(3) A conformity assessment body seeking to become a notified body shall submit to the notifying authority an application, which application shall be in accordance with Article 27 of the Directive and shall be accompanied by the appropriate fee as may be prescribed by the notifying authority. | ||
Notification of conformity assessment bodies | ||
23. (1) The notifying authority may only notify a conformity assessment body where that body— | ||
(a) has made an application to it in accordance with Article 27 of the Directive, and | ||
(b) meets the requirements set out in Article 24 of the Directive. | ||
(2) Notifications by the notifying authority under paragraph (1) shall be made in accordance with the notification procedure set down in Article 28(2), (3) and (4) of the Directive. | ||
(3) The notifying authority shall notify the European Commission and the other Member States of any subsequent relevant changes to the notification. | ||
(4) The assessment and monitoring referred to in Article 21(1) and (2) of the Directive shall be carried out by the Irish National Accreditation Board within the meaning of and in accordance with Regulation (EC) No. 765/2008. | ||
Changes to notifications | ||
24. (1) Where the notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 24 of the Directive, or that it is failing to fulfil its obligations under Articles 32 or 34 of the Directive or under these Regulations, that authority shall restrict, suspend or withdraw notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. | ||
(2) In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall immediately inform the European Commission and the other Member States of the restriction, suspension or withdrawal. | ||
(3) In the event of restriction, suspension or withdrawal of notification or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that notified body are either processed by another notified body or kept available for the responsible notifying and competent authorities at their request. | ||
(4) The notifying authority shall inform the notified body concerned of its decision and allow that body an opportunity to make representations to it. | ||
(5) The notifying authority shall establish one panel per appeal (“appeal panel”) for the purposes of considering appeals under this Regulation. An appeal panel shall consist of at least 3 but not more than 5 persons appointed by the notifying authority, one of whom shall be designated by the notifying authority to be chairperson of the panel. An appeal panel shall not consist of any person who decided or was involved in the decision to restrict, suspend or withdraw the relevant notification pertaining to a notified body. An appeal panel shall establish its own procedure. | ||
(6) Where the notifying authority decides to restrict, suspend or withdraw notification pertaining to a notified body, the latter may, within 14 days of the notification under paragraph (4), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The notification pertaining to a notified body stands restricted, suspended or withdrawn, as the case may be, from the date of the notification of the decision under paragraph (4), unless the appeal panel, upon an application to it, decides otherwise, pending the outcome of the appeal. On hearing the appeal the appeal panel may confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision. The decision of the appeal panel is final except that an appeal lies to the High Court on application to it on a specified point of law. Such an application does not affect the decision of the appeal panel and its operation. | ||
(7) All expenses reasonably incurred by the notifying authority in relation to an appeal before an appeal panel or the High Court shall be borne by the appellant where the appeal panel or the court confirms or confirms with a variation the decisions of the notifying authority. The notifying authority may recover these expenses as a simple contract debt in a court of competent jurisdiction. | ||
Subsidiaries of and subcontracting by notified bodies | ||
25. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall comply with Article 26 of the Directive. | ||
Operational obligations of notified bodies | ||
26. (1) Subject to paragraph (2), a notified body shall— | ||
(a) carry out conformity assessments in accordance with the conformity assessment procedures provided for in Articles 15 and 16 of the Directive as set out in Regulations 16 and 17 of these Regulations, | ||
(b) ensure that conformity assessments are carried out in a proportionate manner, avoiding unnecessary burdens for economic operators, | ||
(c) perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of lift or safety component technology in question and the mass or serial nature of the production process, | ||
(d) in a case where it finds that the essential health and safety requirements of the Directive or these Regulations or corresponding harmonised standards or other technical specifications have not been met by an installer or a manufacturer, require that installer or manufacturer to take appropriate corrective measures and shall not issue a certificate or an approval decision, | ||
(e) in a case where, in the course of the monitoring of conformity following the issue of a certificate or an approval decision, as appropriate, the notified body finds that a lift or a safety component no longer complies, require the installer or the manufacturer to take appropriate corrective measures and suspend or withdraw the certificate or the approval decision if necessary, | ||
(f) in a case where corrective measures under paragraph (e) are not taken by the manufacturer or the installer or do not have the required effect, restrict, suspend or withdraw any certificates or approval decision(s), as appropriate, | ||
(g) inform the manufacturer or installer in question where a decision to restrict, suspend or withdraw any certificate or approval decision is taken under paragraph (f), and | ||
(h) participate in the sectoral group of notified bodies established in accordance with Article 36 of the Directive. | ||
(2) In carrying out its functions under paragraphs 1(b) and 1(c) of this Regulation, a notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the lifts or the safety components with the Directive or these Regulations. | ||
Appeals against decisions of notified bodies | ||
27. (1) The notifying authority shall establish one panel per appeal (“appeal panel”) for the purposes of considering appeals against restrictions, suspensions or withdrawals rendered by notified bodies under Regulation 26. | ||
(2) An appeal panel shall consist of at least 3 but not more than 5 persons appointed by the notifying authority, one of whom shall be designated by the notifying authority to be chairperson of the panel. An appeal panel shall not consist of any person who decided or was involved in the decision to restrict, suspend or withdraw the relevant certificate or approval decision. An appeal panel shall establish its own procedure. | ||
(3) Where a notified body decides to restrict, suspend or withdraw a certificate held by a manufacturer or installer, the latter may, within 14 days of the notification of a decision under Regulation 26(g), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The certificate or approval decision stands restricted, suspended or withdrawn, as the case may be, from the date of notification of the decision under Regulation 26(g), unless the appeal panel, upon an application to it, decides otherwise, pending the outcome of the appeal. On hearing the appeal the appeal panel may confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision. The decision of the appeal panel is final except that an appeal lies to the High Court on application to it on a specified point of law. Such an application does not affect the decision of the appeal panel and its operation. | ||
Information obligation on notified bodies | ||
28. A notified body shall— | ||
(a) inform the notifying authority of the matters referred to in Article 34(1)(a), (b), (c) and (d) of the Directive, | ||
(b) provide the other bodies notified under the Directive or these Regulations carrying out similar conformity assessment activities covering the same type of lifts or the same safety components with relevant information on issues relating to negative conformity assessment results, and | ||
(c) on request, provide other bodies notified under the Directive or these Regulations carrying out similar conformity assessment activities covering the same type of lifts or the same safety components with relevant information on issues relating to positive conformity assessment results. | ||
PART 5 | ||
MARKET SURVEILLANCE, SAFEGUARD PROCEDURE | ||
Market surveillance | ||
29. The market surveillance authority shall organise and carry out market surveillance on lifts and safety components in accordance with Articles 16 to 29 of Regulation (EC) No. 765/2008. | ||
Procedure for dealing with products presenting a risk at national level | ||
30. (1) Where the market surveillance authority has sufficient reason to believe that a lift or a safety component presents a risk to the health or safety of persons or, where appropriate, to the safety of property, it shall carry out an evaluation in relation to the lift or the safety component concerned covering all relevant requirements laid down in the Directive or these Regulations. | ||
(2) The relevant economic operator shall cooperate as necessary with the market surveillance authority as deemed necessary by it in carrying out an evaluation under paragraph (1). | ||
(3) Where, in the course of the evaluation referred to in paragraph (1), the market surveillance authority finds that a lift does not comply with the requirements laid down in the Directive or these Regulations, it shall— | ||
(a) without delay require the installer to take all appropriate corrective actions to bring the lift into compliance with those requirements within a reasonable period commensurate with the nature of the risk, as the authority prescribes, | ||
(b) inform the notified body who carried out the conformity assessment procedure on the lift of the lift’s non-compliance, and | ||
(c) apply the provisions of Article 21 of Regulation (EC) No. 765/2008 to the measures referred to in paragraph 3(a) of this Regulation. | ||
(4) Where, in the course of the evaluation referred to in paragraph (1), the market surveillance authority finds that a safety component does not comply with the requirements laid down in the Directive or these Regulations, it shall— | ||
(a) without delay require the relevant economic operator to take all appropriate corrective actions to bring the safety component into compliance with those requirements, to withdraw the safety component from the market or to recall it within a reasonable period commensurate with the nature of the risk, as the authority prescribes, | ||
(b) inform the notified body who carried out the conformity assessment procedure on the safety component of the component’s non-compliance, and | ||
(c) apply the provisions of Article 21 of Regulation (EC) No 765/2008 to the measures referred to in subparagraph (a). | ||
(5) Where the market surveillance authority considers that non-compliance is not restricted to the State, it shall inform the European Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operators to take. | ||
(6) The relevant economic operator shall ensure that all appropriate corrective action is taken in respect of all the lifts and safety components concerned that it has placed or made available on the market throughout the European Economic Area. | ||
(7) Where an installer does not take adequate corrective action within the period referred to in paragraph (3)(a) of this Regulation, the market surveillance authority shall, without delay, take all appropriate provisional measures to restrict or prohibit the lift from being placed on the market in the State, or the use of the lift concerned or to recall it. | ||
(8) Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 4(a) of this Regulation, the market surveillance authority shall, without delay, take all appropriate provisional measures to prohibit or restrict the safety component from being made available on the market in the State, to withdraw the safety component from the market or to recall it. | ||
(9) The market surveillance authority shall inform the European Commission and the other Member States, without delay, of any measures taken under paragraphs (7) or (8) of this Regulation, and shall— | ||
(a) include all available details, in particular the data necessary for the identification of the non-compliant lift or safety component, the origin of the lift or safety component, the nature of the non-compliance alleged and the risk involved, the nature and duration of the measures taken in the State and the arguments put forward by the relevant economic operators, and | ||
(b) in particular, indicate whether the non-compliance is due to either— | ||
(i) the failure of the lift or the safety component to meet requirements relating to the essential health and safety requirements of the Directive or these Regulations, or | ||
(ii) shortcomings in the harmonised standards referred to in Regulation 15 conferring a presumption of conformity. | ||
(10) Where another Member State has initiated the procedure under Article 38 of the Directive, the market surveillance authority shall, without delay, inform the European Commission and the other Member States— | ||
(a) of any measures adopted and of any additional information at its disposal relating to the non-compliance of the lift or the safety component concerned, or | ||
(b) of its objections, in the event of disagreement with the adopted measure of the other Member State. | ||
(11) Where, within three months of receipt of the information referred to in paragraph (9) of this Regulation, no objection has been raised by either a Member State or the European Commission in respect of a provisional measure taken by the market surveillance authority, that measure shall be deemed to be justified. | ||
(12) The market surveillance authority shall ensure that appropriate restrictive measures, such as withdrawal of a safety component from the market, are taken in respect of the lift or the safety component concerned without delay. | ||
Safeguard procedure | ||
31. (1) Where a measure taken by a Member State under Article 38 of the Directive is considered justified by the European Commission in accordance with the procedure in Article 39(1) of the Directive, the market surveillance authority shall— | ||
(a) in the case of a measure relating to a lift, take the measures necessary to ensure that the placing on the market or use of the non-compliant lift is restricted or prohibited, or that the lift is recalled and inform the European Commission accordingly, or | ||
(b) in the case of a measure relating to a safety component, take the necessary measures to ensure that the non-compliant safety component is withdrawn from the market in the State and inform the European Commission accordingly. | ||
(2) Where a measure proposed by the market surveillance authority is considered unjustified by the European Commission in accordance with the procedure in Article 39(1) of the Directive, the market surveillance authority shall withdraw that measure. | ||
Compliant lifts or safety components which present a risk | ||
32. (1) Where, having carried out an evaluation under Regulation 30, the market surveillance authority finds that, although a lift or a safety component is in compliance with the Directive or these Regulations, it presents a risk to the health or safety of persons and, where appropriate, to the safety of property, it shall— | ||
(a) in the case of a lift, require the installer to take all appropriate measures to ensure that the lift concerned, when placed on the market, no longer presents that risk, to recall the lift or restrict or prohibit its use within a reasonable period, commensurate with the nature of the risk, as it may prescribe, | ||
(b) in the case of a safety component, require the relevant economic operator to take all appropriate measures to ensure that the safety component concerned, when placed on the market, no longer presents that risk, to withdraw the safety component from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe, | ||
(c) immediately inform the European Commission and the other Member States, of all available details and in particular of— | ||
(i) the data necessary for the identification of the lifts or safety components concerned, | ||
(ii) the origin and the supply chain of the lifts or safety components, | ||
(iii) the nature of the risk involved, and | ||
(iv) the nature and the duration of the national measures taken. | ||
(2) An economic operator shall ensure that the corrective action required under paragraph (1) is taken in respect of all the lifts or safety components that the economic operator has placed or made available on the market throughout the European Economic Area. | ||
Formal non-compliance | ||
33. (1) Without prejudice to Regulation 30 the market surveillance authority shall require the relevant economic operator to put an end to the non-compliance concerned where it finds that— | ||
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No. 765/2008 or of Article 19 of the Directive or Regulation 20 of these Regulations, | ||
(b) the CE marking has not been affixed, | ||
(c) the identification number of the notified body has been affixed in violation of Article 19 of the Directive or Regulation 20 of these Regulations or has not been affixed where required by that Article or Regulation, | ||
(d) the EU declaration of conformity has not been drawn up, | ||
(e) the EU declaration of conformity has not been drawn up correctly, | ||
(f) the technical documentation referred to in Annex IV, Parts A and B, Annexes VII, VIII and XI to the Directive, the texts of which are set out in Schedules 4, 7, 8 and 11 to these Regulations, is either not available or not complete, | ||
(g) the name, registered trade name or registered trade mark or the address of the installer, manufacturer, or importer has not been indicated in compliance with Article 7(6), 8(6) or 10(3) of the Directive or Regulation 8(g), 9(h) or 11(2)(c) of these Regulations, | ||
(h) the information allowing identification of the lift or safety component has not been indicated in compliance with Article 7(5) or 8(5) of the Directive or Regulation 8(f) or 9(g) of these Regulations, or | ||
(i) a lift or safety component is not accompanied by the documents referred to in Article 7(7) or 8(7) of the Directive or Regulation 8(h) or 9(i) of these Regulations or those documents are not in compliance with the applicable requirements. | ||
(2) Where the non-compliance referred to in paragraph (1) persists, the market surveillance authority shall take all appropriate measures to restrict or prohibit the use of the lift or to recall it or to restrict or prohibit the making available on the market of the safety component or shall ensure that the component is recalled or withdrawn from the market. | ||
PART 6 | ||
POWERS OF THE MARKET SURVEILLANCE AUTHORITY | ||
General | ||
34. (1) The market surveillance authority shall perform its market surveillance duties in accordance with the relevant provisions of Article 37 of the Directive. | ||
(2) A person who for the time being stands appointed as an inspector under section 62 of the Act of 2005 shall be an inspector for the purpose of the Directive and these Regulations. | ||
(3) An inspector shall, when exercising any power conferred on him or her by these Regulations, if requested to do so by any person affected, produce the certificate of authorisation, or a copy of it, furnished to him or her under section 62(2) of the Act of 2005 together with a form of personal identification. | ||
Powers of inspectors | ||
35. (1) An inspector shall, for the purposes of the Directive and these Regulations, have power to do any one or more of the following: | ||
(a) subject to paragraph (4), at any time enter— | ||
(i) the premises of an economic operator, | ||
(ii) the premises where a product is installed, or | ||
(iii) any other place or premises where entry on same is necessary to ensure that the objectives of the Directive are achieved; | ||
(b) inquire into, search, examine and inspect— | ||
(i) any place referred to in paragraph 1(a), | ||
(ii) any activity, installation, process, procedure, matter or thing at or in that place, and | ||
(iii) any product or any record relating to such product, to ascertain whether the the Directive or these Regulations have been or are being complied with and, for that purpose, take with him or her and use any equipment or materials he or she considers necessary; | ||
(c) require that that place and anything at or in it be left undisturbed for so long as is reasonably necessary for the purposes of any search, examination, investigation, inspection or inquiry under the Directive or these Regulations; | ||
(d) require the person in charge to produce to the inspector— | ||
(i) any product or partly completed product which is in the possession or under the control of such person, and | ||
(ii) any records, and in the case of such information in a non-legible form, to reproduce it in a legible form, and to give to the inspector such information as the inspector may reasonably require in relation to any entries in those records; | ||
(e) inspect and take copies of or extracts from any such records or any electronic information system at that place, including in the case of information in a non-legible form, copies of or extracts from such information in a permanent legible form or require that such copies be provided; | ||
(f) require a person at or in that place by whom or on whose behalf a computer is or has been used to produce or store records or any person having control of, or otherwise concerned with the operation of the computer, to afford the inspector access thereto and all reasonable assistance as the inspector may require; | ||
(g) remove from that place and retain the records (including documents stored in a non-legible form) and copies taken and retain the records for such period as the inspector reasonably considers to be necessary for further examination or until the conclusion of any legal proceedings; | ||
(h) require that records at or in that place be maintained for such period as may be reasonable; | ||
(i) require the person in charge to give the inspector such information as the inspector may reasonably require for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations; | ||
(j) require the person in charge to give the inspector such assistance and facilities within the person’s power or control as are reasonably necessary to enable the inspector to exercise any of his or her powers under these Regulations; | ||
(k) require by notice, at a time and place specified in the notice, any person (including the person in charge) to give the inspector any information that the inspector may reasonably require in relation to the place, any product, equipment, item, activity, installation or procedure at or in the place, and to produce to the inspector any records that are under that person’s power or control; | ||
(l) examine any person whom the inspector reasonably believes to be able to give to the inspector information relevant to any search, examination, investigation, inspection or inquiry under these Regulations and require the person to answer such questions as the inspector may ask relative to the search, examination, investigation, inspection or inquiry and to sign a declaration of the truth of the answers; | ||
(m) require that any procedure be followed for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations; | ||
(n) take any measurements or photographs or make any tape, electrical or other recordings that the inspector considers necessary for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations; | ||
(o) take samples of air, soil, water or waste at or near that place; | ||
(p) where appropriate, install, use and maintain at that place monitoring instruments, systems and seals for the purposes of the Directive or these Regulations; | ||
(q) at that place, or at any other location, carry out, or have carried out, such testing, examination or analysis of any item or product found at that place, as he or she reasonably considers to be necessary, and for that purpose— | ||
(i) require the person in charge to supply to the inspector without charge any product, equipment or item, or samples thereof, or | ||
(ii) remove, or have removed, to another location, any product, equipment or item, or samples thereof; | ||
(r) cause any product found at that place in respect of which there has been or there appears to the inspector to have been a contravention of the Directive or these Regulations, to be subjected to any testing, examination or analysis in accordance with subparagraph (q) (but not so as to damage or destroy it unless same is necessary for the purposes of the Directive or these Regulations) and where an inspector proposes to exercise the power conferred by this subparagraph in the case of any such product found at any place, he or she shall, if so requested by the person in charge, cause anything that is to be done by virtue of that power to be done in the presence of that person, save that the person in charge is responsible for his or her own costs in attending at the exercise of the inspector’s powers and cannot unreasonably delay the inspector in the exercise of those powers; | ||
(s) remove and retain for such period as is necessary any product, equipment or item found at that place for all or any of the following purposes: | ||
(i) to examine or arrange for the examination, testing or analysis of the product, equipment or item; | ||
(ii) to ensure that it is not tampered with before the examination of it under subparagraph (i) is completed; | ||
(iii) to ensure that it is available for use as evidence in any proceedings; | ||
(t) where necessary— | ||
(i) require the disposal or destruction of any product presenting a serious risk in respect of which there has been or there appears to the inspector to have been a contravention of the Directive or these Regulations at the expense of the person in charge, or remove that product and arrange for it to be disposed of or destroyed at the expense of the person in charge, and | ||
(ii) require that such disposal or destruction shall be— | ||
(I) such as will prevent the product from being used or placed on the market, and | ||
(II) in compliance with requirements under the Waste Management Acts 1996 to 2003; | ||
(u) require the recall or removal from the market of a product by the person who has placed or made available that product on the market, where it appears to the inspector that, in relation to that product, the Directive or these Regulations have been contravened. | ||
(2) Where a product is found at a place, and an inquiry is made by an inspector in the course of a search, examination, investigation or inspection as to the identity of the person who supplied that product, the person in charge shall give the inspector the name and address of the supplier from whom the product was purchased or otherwise obtained. | ||
(3) Before exercising any of the powers conferred by subparagraphs (q) to (t) of paragraph (1), an inspector shall, in so far as it is practicable, consult such persons as appear to him or her to be appropriate for the purpose of ascertaining what dangers, if any, there may be in doing what he or she proposes to do under those subparagraphs. | ||
(4) An inspector shall not enter a dwelling other than— | ||
(a) with the consent of the occupier, or | ||
(b) in accordance with a warrant of the District Court issued under paragraph (7) authorising such entry. | ||
(5) The market surveillance authority may authorise such and so many other persons as it considers appropriate to accompany an inspector in the performance of his or her functions. | ||
(6) Where an inspector in the exercise of his or her powers under this Regulation is prevented from entering any of the places or premises specified in Regulation 35(1)(a), an application may be made to the District Court for a warrant under paragraph (7) authorising such entry. | ||
(7) Without prejudice to the powers conferred on an inspector by or under any other provision of this Regulation, if a judge of the District Court is satisfied by information on oath of an inspector that there are reasonable grounds for believing that— | ||
(a) there is any product, equipment or item at any place or premises or any records (including documents stored in a non-legible form) or information, relating to a place, premises or to a product, that the inspector requires to inspect for the purposes of the Directive or these Regulations, held at any place or premises, or | ||
(b) there is, or such an inspection is likely to disclose, evidence of a contravention of the Directive or these Regulations, | ||
the judge may issue a warrant authorising an inspector, accompanied by such other inspectors or such other competent persons as may be appropriate or members of the Garda Síochána as may be necessary, at any time or times, within one month from the date of issue of the warrant, on production of the warrant if requested, to enter that place or premises, if necessary by the use of reasonable force, and perform the functions conferred on an inspector by or under these Regulations. | ||
(8) Where an inspector has reasonable grounds for apprehending any serious obstruction in the performance of his or her functions or otherwise considers it necessary, he or she may be accompanied by a member or members of the Garda Síochána and by any other person or persons authorised by the market surveillance authority, when performing any functions conferred on him or her by or under the Directive or these Regulations. | ||
(9) Where an inspector, upon reasonable grounds, believes that a person has committed an offence under these Regulations he or she may require that person to provide him or her with the person’s name and the address at which the person ordinarily resides. | ||
(10) A statement or admission made by a person pursuant to a requirement under paragraph (1)(i), (k) or (l) shall not be admissible in proceedings brought against that person for an offence (other than an offence under Regulation 45(4)) relating to a breach of, or failure to comply with, an obligation in the said paragraph (1)(i), (k) or (l). | ||
Measures entailing refusal or restriction | ||
36. An inspector who finds that— | ||
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No. 765/2008, Article 19 of the Directive or of Regulation 20 of these Regulations, | ||
(b) the CE marking has not been affixed, | ||
(c) the identification number of the notified body has been affixed in violation of Article 19 of the Directive or Regulation 20, or has not been affixed, where required by said Article or Regulation, | ||
(d) the EU declaration of conformity has not been drawn up, | ||
(e) the EU declaration of conformity has not been drawn up correctly, | ||
(f) the technical documentation referred to in Annex IV, Parts A and B and Annexes VII, VIII and XI to the Directive, the texts of which are set out in Schedules 4, 7, 8 and 11 to these Regulations is either not available or not complete, | ||
(g) the name, registered trade name or registered trade mark or the address of the installer, manufacturer or importer has not been indicated in compliance with Article 7(6),8(6) or 10(3) of the Directive or Regulation 8(g), 9(h) or 11(2)(c), | ||
(h) the information allowing identification of the lift or the safety component has not been indicated in compliance with Article 7(5), 8(5) of the Directive or Regulation 8(f) or 9(g), or | ||
(i) the lift or the safety component for lifts is not accompanied by the documents referred to in Article 7(7), 8(7) of the Directive or Regulation 8(h) or 9(i), or those documents are not in compliance with the applicable requirements, | ||
may issue a direction in writing to the relevant economic operator to put an end to the non-compliance observed within a specified timeframe. | ||
Contravention notice | ||
37. (1) An inspector who is of the opinion that a person— | ||
(a) is contravening or has contravened any of the provisions of the Directive or these Regulations, or | ||
(b) has failed to comply with a direction under Regulation 36, | ||
may serve a notice on the person who has or may reasonably be presumed to have control of the activity concerned. | ||
(2) A contravention notice shall— | ||
(a) state that the inspector is of the opinion referred to in paragraph (1), | ||
(b) specify the grounds for the inspector being of the opinion referred to in paragraph (1) and specify the Regulation or Regulations concerned, | ||
(c) identify the relevant provision in respect of which that opinion is held, | ||
(d) direct the person, where required, to— | ||
(i) remedy the contravention or the matters occasioning that notice, | ||
(ii) cease placing or making available the product on the market or putting it into use, | ||
(iii) remove the product from the market, | ||
(iv) recall the product, | ||
(v) dispose of the product, | ||
(vi) destroy the product where it presents a serious risk, | ||
by a date specified in the notice that shall not be earlier than the end of the period within which an appeal may be made under Regulation (38(1)), | ||
(e) include information regarding the making of an appeal under Regulations 38(1) and (2), | ||
(f) include any other requirement that the inspector considers appropriate, | ||
(g) state that if the person to whom the notice is addressed fails to take such measures as are specified in the notice within the time period specified in that notice, that person commits an offence, and | ||
(h) be signed and dated by the inspector. | ||
(3) A contravention notice may include directions— | ||
(a) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and | ||
(b) to bring the notice to the attention of any person who may be affected by it, or to the public generally. | ||
(4) A person on whom a contravention notice has been served who is of the opinion that the contravention notice has been complied with shall confirm in writing to the inspector that the matters referred to in the notice have been so remedied. | ||
(5) Where a person on whom a contravention notice has been served confirms in writing to the inspector in accordance with paragraph (4) that the matters referred to in the contravention notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of compliance with the contravention notice. | ||
(6) An inspector may— | ||
(a) withdraw or amend a contravention notice at any time, or | ||
(b) where no appeal is made or pending under Regulation 38(1), extend the period specified under paragraph (2)(d) of this Regulation. | ||
(7) Where there is no appeal under Regulation 38(1), the contravention notice shall take effect on the later of— | ||
(a) the end of the period for making an appeal, or | ||
(b) the day specified in the notice. | ||
(8) A person shall comply with a contravention notice under this Regulation. | ||
Appeal against contravention notice | ||
38. (1) A person aggrieved by a contravention notice may, within 14 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served in and, in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice. | ||
(2) A person who appeals under paragraph (1) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal. | ||
(3) Where an appeal under paragraph (1) is taken, and the contravention notice is not cancelled, the notice shall take effect on the later of— | ||
(a) the day next following the day on which the notice is confirmed on appeal or the appeal is withdrawn, or | ||
(b) the day specified in the notice. | ||
(4) Subject to paragraph (5), in the case of a product which the inspector does not consider to present a serious risk requiring rapid intervention under Article 20 of EU Regulation 765/2008, the intended recipient of a measure referred to in Regulation 37(1) shall have the opportunity to make representations within 10 working days of first being advised of the inspector’s intention, to the market surveillance authority in advance of the measure being taken. | ||
(5) Where, due to the urgency of the measure referred to in Regulation 37(1), as justified in particular by public health, security or safety requirements, it is not possible to give the person concerned the opportunity to make representations in advance of the measure being taken, the market surveillance authority shall give such opportunity, as soon as may be, thereafter. | ||
Prohibition notice | ||
39. (1) A prohibition notice may be served by an inspector— | ||
(a) on the person who is or who may reasonably be presumed to be in control of the activity concerned, where that inspector is of the opinion that at any place there is occurring or is likely to occur any activity relating to a product that gives rise to or is likely to give rise to a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, or | ||
(b) on any person in relation to a product in respect of which a direction under Regulation 37 or a contravention notice has been issued but not complied with. | ||
(2) A prohibition notice shall— | ||
(a) state that the inspector is of the opinion referred to in paragraph (1), | ||
(b) state the reason for that opinion, | ||
(c) specify the activity in respect of which that opinion is held, | ||
(d) where in the opinion of the inspector the activity involves a contravention, or likely contravention of any provision of the Directive or these Regulations, specify the provision, | ||
(e) prohibit the carrying on of the activity concerned until the matters that give rise or are likely to give rise to the risk are remedied, | ||
(f) inform the person concerned that he or she may appeal the prohibition notice to the District Court in accordance with Regulation 40(1), | ||
(g) state that if the person to whom the prohibition notice is addressed fails to comply with the notice within the time period specified in the notice, that person commits an offence, and | ||
(h) be signed and dated by the inspector. | ||
(3) A prohibition notice may include directions— | ||
(a) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and | ||
(b) to bring the notice to the attention of any person who may be affected by it, or to the public generally. | ||
(4) A prohibition notice shall take effect— | ||
(a) when the notice is received by the person on whom it is served, or | ||
(b) where an appeal is brought against the prohibition notice, on the day immediately following— | ||
(i) the day on which the notice is confirmed on appeal or the appeal is withdrawn, or | ||
(ii) the day specified in the notice, | ||
whichever occurs later. | ||
(5) A person on whom a prohibition notice has been served who is of the opinion that the matters referred to in the prohibition notice have been remedied by the date specified in the notice shall confirm in writing to the inspector that those matters have been so remedied. | ||
(6) Where a person on whom a prohibition notice has been served confirms in writing to the inspector in accordance with paragraph (5) that the matters referred to in the prohibition notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of such compliance with the prohibition notice. | ||
(7) An inspector may at any time withdraw a prohibition notice if— | ||
(a) the inspector is satisfied that the activity to which the notice relates no longer gives rise to a serious risk to safety or health, or | ||
(b) the inspector is satisfied that the notice was issued in error or is incorrect in some material respect. | ||
(8) A person shall comply with a prohibition notice under this Regulation. | ||
Appeal against prohibition notice | ||
40. (1) A person on whom a prohibition notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice. | ||
(2) Where, on the hearing of an appeal under this Regulation, a prohibition notice is confirmed, notwithstanding Regulation 39(4), the judge by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition notice for such period as in the circumstances of the case the judge considers appropriate. | ||
(3) A person who— | ||
(a) brings an appeal under paragraph (1), or | ||
(b) applies for the suspension of the operation of a prohibition notice under this Regulation, | ||
shall at the same time notify the market surveillance authority of the appeal or the application, and the grounds for the appeal or application. | ||
(4) In the case of an appeal or any application to suspend the operation of the prohibition notice under this Regulation, the market surveillance authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application. | ||
(5) The bringing of an appeal against a prohibition notice shall not have the effect of suspending the operation of the notice but the appellant may apply to the court to have the operation of the notice suspended until the appeal is disposed of and, on such application, the court may, if it thinks proper to do so, direct that the operation of the notice be suspended until the appeal is disposed of. | ||
Order of the High Court | ||
41. (1) Where a person contravenes a prohibition notice an inspector may apply ex parte to the High Court for an order prohibiting the continued contravention of the notice. | ||
(2) The High Court may, upon an application under this Regulation, order the person on whom the prohibition notice concerned was served to cease doing such acts as the High Court directs. | ||
Information notice | ||
42. (1) An inspector, or the market surveillance authority, may, by notice served on a person, require the person to give, within such period and in such form as may be specified in the notice, any information specified in the notice that the inspector or the market surveillance authority may reasonably require for the proper performance of his or her or its functions under the Directive or these Regulations. | ||
(2) Upon the written application of the person on whom the notice is served, the period specified in the information notice may be extended by and at the discretion of— | ||
(i) the market surveillance authority, | ||
(ii) an inspector. | ||
(3) A person on whom an information notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice. | ||
(4) A person who appeals under paragraph (3) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal. | ||
(5) Where, on the hearing of an appeal under paragraph (3), an information notice is confirmed or varied, the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the judge considers appropriate. | ||
(6) Subject to paragraph (7), a person on whom an information notice is served shall comply with the notice before the later of— | ||
(a) the end of the period specified in the notice, or | ||
(b) where the period referred to in subparagraph (a) is extended under paragraph (2), the end of that extended period. | ||
(7) Where an appeal is brought under this Regulation, and the information notice to which the appeal relates is confirmed or varied or the appeal is withdrawn, the person on whom the notice is served shall comply with the notice before— | ||
(a) the day immediately following the day on which the notice is confirmed or varied or the appeal is withdrawn, | ||
(b) the end of the period specified in the notice, or | ||
(c) where the operation of the notice has been suspended under paragraph (5), the end of the period of suspension, | ||
whichever occurs latest. | ||
Service of notifications | ||
43. (1) Subject to paragraphs (2) and (3), a notice or other document required or authorised to be served on, sent or given to a person shall be addressed to the person concerned by name and may be given to the person in one of the following ways— | ||
(a) by delivering it to the person, | ||
(b) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address, | ||
(c) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address, | ||
(d) if the person concerned has agreed to service of notices by means of an electronic communication (within the meaning assigned by section 2 of the Electronic Commerce Act 2000 ), service by such means, provided that there is a facility for confirming receipt of electronic communication and that such receipt has been confirmed, | ||
(e) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the compliance notice relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises, or | ||
(f) by any other means that may be prescribed. | ||
(2) Where a notice or other document required or authorised to be served on, sent or given to a person is to be given to a person who is the owner or occupier of land or property and the name of the person cannot be ascertained by reasonable inquiry, it may be addressed to the person by using the words “the owner” or, as the case may require, “the occupier”. | ||
(3) For the purposes of this Regulation, a company within the meaning of the Companies Acts shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business. | ||
Sharing information on the application of the Directive | ||
44. (1) The market surveillance authority may provide information to any European Union information network, the European Commission or a competent authority of another Member State for the purpose of sharing information related to the application of the Directive. | ||
(2) The market surveillance authority may, in the interest of the protection of safety, take such measures as it considers appropriate to bring to the attention of the public, any matter of concern arising from the requirements of these Regulations. | ||
PART 7 | ||
OFFENCES AND PENALTIES | ||
Offences | ||
45. (1) A person who contravenes a provision or requirement of Regulation 5, 7, 8, 9, 10(3), 11, 12, 14, 17(2), 30(2), 30(6), or 32(2) commits an offence. | ||
(2) A person who contravenes a requirement of Regulation 35, 36, 37, 39 or 42 or a notice issued or measure taken thereunder, commits an offence. | ||
(3) A person who, in relation to the CE marking or any document required for the purposes of these Regulations— | ||
(a) forges or counterfeits any such document, | ||
(b) gives or signs a document or makes a marking knowing it to be false in any material particular, | ||
(c) knowingly uses a marking or document so forged or counterfeited, or which is false as aforesaid, | ||
(d) knowingly uses as applying to any person or product a marking or document which does not so apply, | ||
(e) knowingly connives at any such forging, counterfeiting, giving, signing, or using, | ||
(f) knowingly makes a false entry in any such document which is so required to be kept, served or sent, | ||
(g) knowingly uses any such false entry, or | ||
(h) knowingly has, without lawful authority, a forged marking or document or an altered marking or document in his or her possession, | ||
commits an offence. | ||
(4) Any person who obstructs or interferes with an inspector or a member of the Garda Síochána in the course of exercising a power conferred on him or her by these Regulations or a warrant under Regulation 35(7) or impedes the exercise by the inspector or member, as the case may be, of such power, or fails or refuses to comply with a request or requirement of, or to answer a question asked by, an inspector or such a member pursuant to a power conferred by these Regulations, or in purported compliance with such request or requirement, or who in answer to such question gives information to the inspector or member that he or she knows to be false or misleading in any material respect, commits an offence. | ||
(5) A person who falsely represents himself or herself to be an inspector commits an offence. | ||
(6) A person who, at any time during the period of 3 months immediately following the affixing of a notice in accordance with Regulation 43(1)(e), removes, alters, damages or defaces the notice without lawful authority commits an offence. | ||
(7) A person who, prevents or attempts to prevent any person from answering any question to which an inspector may require an answer under Regulation 35, commits an offence. | ||
(8) A person who, fails to comply with a bona fide request, instruction or directions from an inspector in the exercise of his or her functions under these Regulations, commits an offence. | ||
(9) Where an offence under any of these Regulations is committed by reason of a failure to do something at or within a time fixed by or under any of those provisions, the offence shall be deemed to continue until that thing is done. | ||
(10) A person who states to the market surveillance authority that another person has committed an offence under this Regulation or has failed to comply with a provision of these Regulations, knowing the statement to be false, commits an offence. | ||
(11) A person who, in purported compliance with a requirement in an information notice, furnishes information to the market surveillance authority that he or she knows to be false or misleading in a material respect commits an offence. | ||
Penalties | ||
46. (1) A person guilty of an offence under Regulation 45 shall be liable— | ||
(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 6 months or both, or | ||
(b) on conviction on indictment, to a fine not exceeding €500,000 or imprisonment for a term not exceeding 2 years or both. | ||
(2) Where a person is convicted of an offence under these Regulations in proceedings brought by the market surveillance authority, or instituted following an investigation by the authority, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the authority the costs and expenses, measured by the court, incurred by the authority in relation to the investigation, detection and prosecution of the offence, including the costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisers engaged by the authority. | ||
Offences by bodies corporate | ||
47. Where an offence under these Regulations has been committed by a body corporate and is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a person being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person as well as the body corporate commits an offence and shall be liable to be proceeded against and punished as if he or she had committed the first-mentioned offence. | ||
Prosecution of offences | ||
48. (1) Subject to paragraph (2), summary proceedings in relation to an offence under these Regulations may be brought and prosecuted by the market surveillance authority. | ||
(2) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act 1851 , summary proceedings for an offence under Regulation 45 may be instituted at any time within 12 months from the date on which the offence was committed or alleged to have been committed. | ||
PART 8 | ||
MISCELLANEOUS | ||
Appeal to Circuit Court from certain orders of District Court | ||
49. For the avoidance of doubt, an order of the District Court confirming, varying or cancelling a notice under Regulation 38, 40 or 42 is a decision of a judge of the District Court for the purposes of section 84 of the Courts of Justice Acts 1924. | ||
Notice or direction to be in writing | ||
50. Any notice or direction under these Regulations shall be in writing. | ||
Immunity | ||
51. None of the following persons, that is to say, the market surveillance authority, an inspector or a member or a member of staff of the market surveillance authority shall be liable in damages in respect of any act done or omitted to be done by it or him or her in the performance, or purported performance, of that person’s functions under these Regulations, unless the act or omission concerned was done in bad faith. | ||
Indemnification | ||
52. The market surveillance authority shall, subject to the provisions of any enactment or rule of law, indemnify an inspector appointed by it, or a member or a member of staff of the market surveillance authority, in respect of any act done or omitted to be done by him or her in the performance, or purported performance, of his or her functions under these Regulations as such inspector, member or member of staff, unless the act or omission concerned was done in bad faith. | ||
Restrictions on the disclosure of information | ||
53. A person in receipt of information as a result of the application of these Regulations shall treat same as confidential. In particular, business, professional and trade secrets shall be treated as confidential unless the divulging of such information is— | ||
(a) for the purpose of the discharge of functions under these Regulations, | ||
(b) made with the consent of the person to whom the information applies, or | ||
(c) for the purposes of— | ||
(i) any legal proceedings (including by means of a report to a coroner holding an inquest under the Coroners Acts 1962 and 2005 on the body of a person whose death may have been caused through personal injury), or | ||
(ii) any investigation or special report under section 70 of the Act of 2005, | ||
(d) necessary in order to protect the health and safety of persons, | ||
(e) required by the provisions of these Regulations or the Directive, or | ||
(f) ordered by a court of law. | ||
Transitional | ||
54. (1) The putting into service of lifts or the making available on the market of safety components for lifts, in conformity with Directive 95/16/EC or the Regulations of 1998, and which were put into service or placed on the market before 20 April 2016 continues to be lawful. | ||
(2) Certificates and decisions issued by notified bodies under Directive 95/16/EC or the Regulations of 1998 shall be valid under these Regulations. | ||
Revocation | ||
55. The European Communities (Lifts) Regulations 1998 ( S.I. No. 246 of 1998 ) and the European Communities (Lifts) (Amendment) Regulations 2008 ( S.I. No. 406 of 2008 ), cited together as the European Communities (Lifts) (Amendment) Regulations 1998 and 2008, are revoked. | ||
Regulations 2, 6, 7, 8, 9, 11, 12, 15, 17 and 18 | ||
SCHEDULE 1 | ||
TEXT OF ANNEX I TO THE DIRECTIVE | ||
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS | ||
PRELIMINARY REMARKS | ||
1. Obligations under essential health and safety requirements apply only where the corresponding risk exists for the lift or safety component for lifts in question when used as intended by the installer or the manufacturer. | ||
2. The essential health and safety requirements contained in the Directive are imperatives. However, given the present state of the art, the objectives which they lay down may not be attainable. In such cases, and to the greatest extent possible, the lift or safety components for lifts must be designed and constructed in such a way as to approximate to those objectives. | ||
3. The manufacturer and the installer are under an obligation to carry out a risk assessment in order to identify all the risks which apply to their products; they must then design and construct them taking account of the assessment. | ||
1. GENERAL | ||
1. 1. Application of Directive 2006/42/EC | ||
Where the relevant risk exists and is not dealt with in this Schedule, the essential health and safety requirements of Annex I to Directive 2006/42/EC of the European Parliament and of the Council5 apply. The essential health and safety requirements of point 1.1.2 of Annex I to Directive 2006/42/EC apply in any event. | ||
1. 2. Carrier | ||
The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer. | ||
Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them. | ||
1. 3. Means of suspension and means of support | ||
The means of suspension and/or support of the car, its attachments and any terminal parts thereof must be selected and designed so as to ensure an adequate level of overall safety and to minimize the risk of the car falling, taking into account the conditions of use, the materials used and the conditions of manufacture. | ||
Where ropes or chains are used to suspend the car, there must be at least two independent cables or chains, each with its own anchorage system. Such ropes and chains must have no joins or splices except where necessary for fixing or forming a loop. | ||
1. 4. Control of loading (including overspeed) | ||
1. 4.1. Lifts must be so designed, constructed and installed as to prevent normal starting if the rated load is exceeded. | ||
1. 4.2. Lifts must be equipped with an overspeed governor. | ||
These requirements do not apply to lifts in which the design of the drive system prevents overspeed. | ||
1. 4.3. Fast lifts must be equipped with a speed-monitoring and speed-limiting device. | ||
1. 4.4. Lifts driven by friction pulleys must be designed so as to ensure stability of the traction cables on the pulley. | ||
1. 5. Machinery | ||
1. 5.1. All passenger lifts must have their own individual lift machinery. This requirement does not apply to lifts in which the counterweights are replaced by a second car. | ||
1. 5.2. The installer must ensure that the lift machinery and the associated devices of a lift are not accessible except for maintenance and in emergencies. | ||
1. 6. Controls | ||
1. 6.1. The controls of lifts intended for use by unaccompanied disabled persons must be designed and located accordingly. | ||
1. 6.2. The function of the controls must be clearly indicated. | ||
1. 6.3. The call circuits of a group of lifts may be shared or interconnected. | ||
1. 6.4. Electrical equipment must be so installed and connected that: | ||
(a) there can be no possible confusion with circuits which do not have any direct connection with the lift; | ||
(b) the power supply can be switched while on load; | ||
(c) movements of the lift are dependent on electrical safety devices in a separate electrical safety circuit; | ||
(d) a fault in the electrical installation does not give rise to a dangerous situation. | ||
2. RISKS FOR PERSONS OUTSIDE THE CAR | ||
2. 1. The lift must be designed and constructed to ensure that the space in which the car travels is inaccessible except for maintenance or in emergencies. Before a person enters that space, normal use of the lift must be made impossible. | ||
2. 2. The lift must be designed and constructed to prevent the risk of crushing when the car is in one of its extreme positions. | ||
The objective will be achieved by means of free space or refuge beyond the extreme positions. However, in specific cases, in affording Members States the possibility of giving prior approval, particularly in existing buildings, where this solution is impossible to fulfil, other appropriate means may be provided to avoid this risk. | ||
2. 3. The landings at the entrance and exit of the car must be equipped with landing doors of adequate mechanical resistance for the conditions of use envisaged. | ||
An interlocking device must prevent during normal operation: | ||
(a) starting movement of the car, whether or not deliberately activated, unless all landing doors are shut and locked; | ||
(b) the opening of a landing door when the car is still moving and outside a prescribed landing zone. | ||
However, all landing movements with the doors open shall be allowed in specified zones on condition that the levelling speed is controlled. | ||
3. RISKS FOR PERSONS IN THE CAR | ||
3. 1. Lift cars must be completely enclosed by full-length walls, fitted floors and ceilings included, with the exception of ventilation apertures, and with full-length doors. These doors must be so designed and installed that the car cannot move, except for the landing movements referred to in the third subparagraph of point 2.3, unless the doors are closed, and comes to a halt if the doors are opened. | ||
The doors of the car must remain closed and interlocked if the lift stops between two levels where there is a risk of a fall between the car and the shaft or if there is no shaft. | ||
3. 2. In the event of a power cut or failure of components the lift must have devices to prevent free fall or uncontrolled movements of the car. | ||
The device preventing the free fall of the car must be independent of the means of suspension of the car. | ||
This device must be able to stop the car at its rated load and at the maximum speed anticipated by the installer. Any stop occasioned by this device must not cause deceleration harmful to the occupants whatever the load conditions. | ||
3. 3. Buffers must be installed between the bottom of the shaft and the floor of the car. | ||
In this case, the free space referred to in point 2.2 must be measured with the buffers totally compressed. | ||
This requirement does not apply to lifts in which the car cannot enter the free space referred to in point 2.2 by reason of the design of the drive system. | ||
3. 4. Lifts must be so designed and constructed as to make it impossible for them to be set in motion if the device provided for in point 3.2 is not in an operational position. | ||
4. OTHER RISKS | ||
4. 1. The landing doors and car doors or the two doors together, where motorized, must be fitted with a device to prevent the risk of crushing when they are moving. | ||
4. 2. Landing doors, where they have to contribute to the protection of the building against fire, including those with glass parts, must be suitably resistant to fire in terms of their integrity and their properties with regard to insulation (containment of flames) and the transmission of heat (thermal radiation). | ||
4. 3. Counterweights must be so installed as to avoid any risk of colliding with or falling on to the car. | ||
4. 4. Lifts must be equipped with means enabling people trapped in the car to be released and evacuated. | ||
4. 5. Cars must be fitted with two-way means of communication allowing permanent contact with a rescue service. | ||
4. 6. Lifts must be so designed and constructed that, in the event of the temperature in the lift machine exceeding the maximum set by the installer, they can complete movements in progress but refuse new commands. | ||
4. 7. Cars must be designed and constructed to ensure sufficient ventilation for passengers, even in the event of a prolonged stoppage. | ||
4. 8. The car should be adequately lit whenever in use or whenever a door is opened; there must also be emergency lighting. | ||
4. 9. The means of communication referred to in point 4.5 and the emergency lighting referred to in point 4.8 must be designed and constructed so as to function even without the normal power supply. Their period of operation should be long enough to allow normal operation of the rescue procedure. | ||
4. 10. The control circuits of lifts which may be used in the event of fire must be designed and manufactured so that lifts may be prevented from stopping at certain levels and allow for priority control of the lift by rescue teams. | ||
5. MARKING | ||
5. 1. In addition to the minimum particulars required for any machine pursuant to point 1.7.3 of Annex I to Directive 2006/42/EC, each car must bear an easily visible plate clearly showing the rated load in kilograms and the maximum number of passengers which may be carried. | ||
5. 2. If the lift is designed to allow people trapped in the car to escape without outside help, the relevant instructions must be clear and visible in the car. | ||
6. INSTRUCTIONS | ||
6. 1. The safety components for lifts referred to in Schedule 3 must be accompanied by instructions, so the following can be carried out effectively and without danger: | ||
(a) assembly; | ||
(b) connection; | ||
(c) adjustment; | ||
(d) maintenance. | ||
6. 2. Each lift must be accompanied by instructions. The instructions shall contain at least the following documents: | ||
(a) instructions containing the plans and diagrams necessary for normal use and relating to maintenance, inspection, repair, periodic checks and the rescue operations referred to in point 4.4; | ||
(b) a logbook in which repairs and, where appropriate, periodic checks can be noted. | ||
Regulation 18 | ||
SCHEDULE 2 | ||
TEXT OF ANNEX II TO THE DIRECTIVE | ||
A. CONTENT OF THE EU DECLARATION OF CONFORMITY FOR SAFETY COMPONENTS FOR LIFTS | ||
The EU declaration of conformity for safety components for lifts shall contain the following information: | ||
(a) name and address of the manufacturer; | ||
(b) where appropriate, name and address of the authorised representative; | ||
(c) description of the safety component for lifts, details of type or series and serial number (if any); it may, where necessary for the identification of the safety component, include an image; | ||
(d) safety function of the safety component for lifts, if not obvious from the description; | ||
(e) year of manufacture of the safety component for lifts; | ||
(f) all relevant provisions with which the safety component for lifts complies; | ||
(g) a statement that the safety component for lifts is in conformity with the relevant Union harmonisation legislation; | ||
(h) where appropriate, reference(s) to harmonised standard(s) used; | ||
(i) where appropriate, the name, address and identification number of the notified body which carried out the EU-type examination of safety components for lifts set out in Schedule 4, Part A and Schedule 4, and the reference of the EU-type examination certificate issued by that notified body; | ||
(j) where appropriate, the name, address and identification number of the notified body which carried out the conformity to type with random checking for safety components for lifts set out in Schedule 9; | ||
(k) where appropriate, the name, address and identification number of the notified body which approved the quality system operated by the manufacturer in accordance with the conformity assessment procedure set out in Schedule 6 or 7; | ||
(l) the name and function of the person empowered to sign the declaration on behalf of the manufacturer or his authorised representative; | ||
(m) place and date of signature; | ||
(n) signature. | ||
B. CONTENT OF THE EU DECLARATION OF CONFORMITY FOR LIFTS | ||
The EU declaration of conformity for lifts shall be drafted in the same language as the instructions referred to in Schedule 1, point 6.2 and contain the following information: | ||
(a) name and address of the installer; | ||
(b) where appropriate business name and address of the authorised representative; | ||
(c) description of the lift, details of the type or series, serial number and address where the lift is installed; | ||
(d) year of installation of the lift; | ||
(e) all relevant provisions to which the lift conforms; | ||
(f) a statement that the lift is in conformity with the relevant Union harmonisation legislation; | ||
(g) where appropriate, reference(s) to harmonised standard(s) used; | ||
(h) where appropriate, the name, address and identification number of the notified body which carried out the EU-type examination of lifts set out in Schedule 4, Part B and the reference of the EU-type examination certificate issued by that notified body; | ||
(i) where appropriate, the name, address and identification number of the notified body which carried out the unit verification for lifts set out in Schedule 7; | ||
(j) where appropriate, the name, address and identification number of the notified body which carried out the final inspection for lifts set out in Schedule 5; | ||
(k) where appropriate, the name, address, and identification number of the notified body which approved the quality assurance system operated by the installer in accordance with the conformity assessment procedure set out in Schedule 10, 11 or 12; | ||
(l) the name and function of the person empowered to sign the declaration on behalf of the installer or his authorised representative; | ||
(m) place and date of signature; | ||
(n) signature. | ||
Regulation 4 | ||
SCHEDULE 3 | ||
TEXT OF ANNEX III TO THE DIRECTIVE | ||
LIST OF SAFETY COMPONENTS FOR LIFTS | ||
1. Devices for locking landing doors. | ||
2. Devices to prevent falls referred to in point 3.2 of Schedule 1 to prevent the car from falling or uncontrolled movements. | ||
3. Overspeed limitation devices. | ||
4. (a) Energy-accumulating buffers: | ||
(i) non-linear, or | ||
(ii) with damping of the return movement. | ||
(b) Energy-dissipating buffers. | ||
5. Safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls. | ||
6. Electric safety devices in the form of safety circuits containing electronic components. | ||
Regulations 16, 17, 33 and 36 | ||
SCHEDULE 4 | ||
TEXT OF ANNEX IV TO THE DIRECTIVE | ||
EU-TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS | ||
(module B) | ||
A. Eu-Type Examination of Safety Components For Lifts | ||
1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a safety component for lifts and verifies and attests that it satisfies the applicable requirements of Schedule 1 and will enable a lift in which it is correctly incorporated to satisfy those requirements. | ||
2. The application for EU-type examination shall be lodged by the manufacturer, or his authorised representative, with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well and the place of manufacture of the safety components for lifts; | ||
(b) a written declaration that the same application has not been lodged with any other notified body; | ||
(c) the technical documentation; | ||
(d) a representative specimen of the safety component for lifts or details of the place where it can be examined. The notified body may request further specimens if needed for carrying out the test programme; | ||
(e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents, including other relevant technical specifications, that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. | ||
3. The technical documentation shall make it possible to assess whether the safety component for lifts meets the conditions referred to in point 1 and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the safety component for lifts. | ||
The technical documentation shall contain, where applicable, the following: | ||
(a) a description of the safety component for lifts, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements); | ||
(b) design and manufacturing drawings and diagrams; | ||
(c) explanations necessary for the understanding of those drawings and diagrams and the operation of the safety component for lifts; | ||
(d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to enable the safety component for lifts to meet one or both of the conditions referred to in point 1, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; | ||
(e) results of design calculations performed by or for the manufacturer; | ||
(f) test reports; | ||
(g) a copy of the instructions for the safety components for lifts; | ||
(h) steps taken at the manufacturing stage to ensure that series-produced safety components for lifts conform to the safety component for lifts examined. | ||
4. The notified body shall: | ||
(a) examine the technical documentation and the supporting evidence to assess the adequacy of the technical design of the safety component for lifts; | ||
(b) agree with the applicant on a location where the examinations and tests will be carried out; | ||
(c) verify that the representative specimen(s) has(have) been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications; | ||
(d) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the specifications of the relevant harmonised standards, these have been applied correctly; | ||
(e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the specifications of the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer, including those in other relevant technical specifications applied, enable the safety component for lifts to meet the conditions referred to in point 1. | ||
The notified body shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. | ||
5. Where the type of the safety component for lifts meets the conditions referred to in point 1, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer the conclusions of the EU-type examination, any conditions of validity of the certificate and the particulars necessary to identify the approved type. | ||
The EU-type examination certificate may have one or more annexes attached. | ||
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured safety components for lifts with the examined type to be evaluated and to allow for in-service control. | ||
Where the type of the safety component for lifts does not satisfy the conditions referred to in point 1, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. | ||
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation and the evaluation report, for 15 years from the date of issue of that certificate. | ||
6. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer meet the conditions referred to in point 1 and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. | ||
7. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of any modification to the approved type that may affect the conformity of the safety component for lifts with the conditions referred to in point 1 or the conditions of validity of the EU-type examination certificate. | ||
The notified body shall examine the modification and inform the applicant whether the EU-type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate, the notified body shall issue an addition to the original EU type- examination certificate or ask for a new application for an EU-type examination to be submitted. | ||
8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and any additions thereto refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. | ||
9. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the report on the examinations, verifications and tests carried out by the notified body. | ||
10. The manufacturer shall keep with the technical documentation a copy of EU-type examination certificates, its annexes and additions at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. | ||
11. Authorised representative | ||
The manufacturer’s authorised representative may lodge the application referred to in point 2 and fulfil the obligations set out in points 7 and 10, provided that they are specified in the mandate. | ||
B. EU-TYPE EXAMINATION OF LIFTS | ||
1. EU-type examination of lifts is the part of a conformity assessment procedure in which a notified body examines the technical design of a model lift, or a lift for which there is no provision for an extension or variant, and verifies and attests that it meets the applicable essential requirements set out in Schedule 1. | ||
EU-type examination of a lift includes an examination of a representative specimen of a complete lift. | ||
2. The application for EU-type examination shall be lodged by the installer or his authorised representative with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the installer; and, if the application is lodged by the authorised representative, his name and address as well; | ||
(b) a written declaration that the same application has not been lodged with any other notified body; | ||
(c) the technical documentation; | ||
(d) details of the place where the specimen lift can be examined. The specimen lift submitted for examination shall include the terminal parts and be capable of serving at least three levels (top, middle and bottom); | ||
(e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents, including other relevant technical specifications that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the installer, or by another testing laboratory on his behalf and under his responsibility. | ||
3. The technical documentation shall make it possible to assess the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1. | ||
The technical documentation shall contain, where applicable, the following: | ||
(a) a description of the model lift indicating clearly all the permitted variations of the model lift; | ||
(b) design and manufacturing drawings and diagrams; | ||
(c) explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift; | ||
(d) a list of the essential health and safety requirements taken into consideration; | ||
(e) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; | ||
(f) a copy of the EU declarations of conformity of the safety components for lifts incorporated in the lift; | ||
(g) results of calculations performed by or for the installer; | ||
(h) test reports; | ||
(i) a copy of the instructions referred to in point 6.2 of Schedule 1; | ||
(j) steps taken at the installation stage to ensure that the series-produced lift conforms to the essential health and safety requirements set out in Schedule 1. | ||
4. The notified body shall: | ||
(a) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the model lift or of the lift for which there is no provision for an extension or variant; | ||
(b) agree with the installer on a location where the examinations and tests will be carried out; | ||
(c) examine the specimen lift to check that it has been manufactured in accordance with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications; | ||
(d) carry out appropriate examinations and tests, or have them carried out, to check whether, where the installer has chosen to apply the specifications of the relevant harmonised standards, these have been applied correctly; | ||
(e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the specifications of the relevant harmonised standards have not been applied, the solutions adopted by the installer, including those in other relevant technical specifications applied, meet the corresponding essential health and safety requirements of the Directive. | ||
5. The notified body shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the installer. | ||
6. Where the type meets the essential health and safety requirements set out in Schedule 1 applicable to the lift concerned, the notified body shall issue an EU-type examination certificate to the installer. That certificate shall contain the name and address of the installer, the conclusions of the EU-type examination, any conditions of validity of the certificate and the particulars necessary to identify the approved type. | ||
The EU-type examination certificate may have one or more annexes attached. | ||
The EU-type examination certificate and its annexes shall contain all the information necessary to enable the conformity of lifts with the approved type to be assessed during the final inspection. | ||
Where the type does not comply with the essential health and safety requirements set out in Schedule 1, the notified body shall refuse to issue an EU-type examination certificate and shall inform the installer accordingly, giving detailed reasons for its refusal. | ||
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation and the evaluation report for 15 years from the date of issue of that certificate. | ||
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the essential health and safety requirements set out in Schedule 1, and shall determine whether such changes require further investigation. If so, the notified body shall inform the installer accordingly. | ||
8. The installer shall inform the notified body of any modifications to the approved type, including variations not specified in the original technical documentation, that may affect the conformity of the lift with the essential health and safety requirements set out in Schedule 1 or the conditions of validity of the EU-type examination certificate. | ||
The notified body shall examine the modification and inform the installer whether the EU-type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate the notified body shall issue an addition to the original EU-type examination certificate or ask for a new application for an EU-type examination to be submitted. | ||
9. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and any additions thereto refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and additions thereto which it has issued. | ||
10. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the report on the examinations, verifications and tests carried out by the notified body. | ||
11. The installer shall keep with the technical documentation a copy of the EU-type examination certificates, its annexes and additions at the disposal of the national authorities for 10 years after the lift has been placed on the market. | ||
12. Authorised representative | ||
The installer’s authorised representative may lodge the application referred to in point 2 and fulfil the obligations set out in points 8 and 11, provided that they are specified in the mandate. | ||
Regulations 17, 18 and 20 | ||
SCHEDULE 5 | ||
TEXT OF ANNEX V TO THE DIRECTIVE | ||
FINAL INSPECTION FOR LIFTS | ||
1. Final inspection is the part of a conformity assessment procedure whereby a notified body ascertains and certifies that a lift subject to an EU-type examination certificate or designed and manufactured according to an approved quality system satisfies the essential health and safety requirements set out in Schedule 1. | ||
2. Obligations of the installer | ||
The installer shall take all measures necessary to ensure that the lift being installed complies with the applicable essential health and safety requirements set out in Schedule 1 and with one of the following: | ||
(a) an approved type described in an EU-type examination certificate; | ||
(b) a lift designed and manufactured in accordance with a quality system pursuant to Schedule 11 and the EU design examination certificate if the design is not wholly in accordance with the harmonised standards. | ||
3. Final Inspection | ||
A notified body chosen by the installer shall carry out the final inspection of the lift about to be placed on the market in order to check the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1. | ||
3. 1. The installer shall lodge an application for final inspection with a single notified body of his choice and shall provide to the notified body the following documents: | ||
(a) the plan of the complete lift; | ||
(b) the plans and diagrams necessary for final inspection, in particular control circuit diagrams; | ||
(c) a copy of the instructions referred to in Schedule 1, point 6.2; | ||
(d) a written declaration that the same application has not been lodged with any other notified body. | ||
The notified body may not require detailed plans or precise information not necessary for verifying the conformity of the lift. | ||
The appropriate examinations and tests set out in the relevant harmonised standard(s) or equivalent tests shall be carried out in order to check the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1. | ||
3. 2. The examinations shall include at least one of the following: | ||
(a) examination of the documents referred to in point 3.1 to check that the lift conforms with the approved type described in the EU-type examination certificate pursuant to Schedule 4, Part B; | ||
(b) examination of the documents referred to in point 3.1 to check that the lift conforms with the lift designed and manufactured in accordance with an approved quality system pursuant to Schedule 11 and if the design is not wholly in accordance with the harmonised standards, with the EU design examination certificate. | ||
3. 3. The tests of the lift shall include at least the following: | ||
(a) operation of the lift both empty and at maximum load to ensure correct installation and operation of the safety devices (end stops, locking devices, etc.); | ||
(b) operation of the lift at both maximum load and empty to ensure the correct functioning of the safety devices in the event of loss of power; | ||
(c) static test with a load equal to 1.25 times the rated load. | ||
The rated load shall be that referred to in Schedule 1, point 5. | ||
After these tests, the notified body shall check that no distortion or deterioration which could impair the use of the lift has occurred. | ||
4. If the lift satisfies the essential health and safety requirements set out in Schedule 1, the notified body shall affix or have affixed its identification number adjacent to the CE marking in accordance with Articles 18 and 19 and shall issue a final inspection certificate which mentions the examinations and tests carried out. | ||
The notified body shall fill in the corresponding pages in the logbook referred to in Schedule 1, point 6.2. | ||
If the notified body refuses to issue the final inspection certificate, it shall state the detailed reasons for refusal and indicate the necessary corrective measures to be taken. Where the installer again applies for final inspection, he shall apply to the same notified body. | ||
5. CE marking and EU declaration of conformity | ||
5. 1. The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift. | ||
5. 2. The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity and the final inspection certificate at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. | ||
6. The Commission and the Member States may obtain a copy of the final inspection certificate on request. | ||
7. Authorised representative | ||
The installer’s obligations set out in points 3.1 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulations 16, 18 and 20 | ||
SCHEDULE 6 | ||
TEXT OF ANNEX VI TO THE DIRECTIVE | ||
CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS | ||
(module E) | ||
1. Conformity to type based on product quality assurance for safety components for lifts is the part of the conformity assessment procedure whereby a notified body assesses the quality system of a manufacturer in order to ensure that the safety components for lifts are manufactured and monitored in conformity with the type described in the EU-type examination certificate, satisfy the applicable requirements of Schedule 1 and will enable a lift to which they are correctly incorporated to satisfy those requirements. | ||
2. Obligations of the manufacturer | ||
The manufacturer shall operate an approved quality system for final inspection and testing of the safety components for lifts as specified in point 3, and shall be subject to surveillance as specified in point 4. | ||
3. Quality system | ||
3. 1. The manufacturer shall lodge an application for assessment of his quality system for the safety components for lifts concerned with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; | ||
(b) a written declaration that the same application has not been lodged with any other notified body; | ||
(c) the address of the premises where final inspection and testing of the safety components for lifts are carried out; | ||
(d) all relevant information on the safety components for lifts to be manufactured; | ||
(e) the documentation concerning the quality system; | ||
(f) the technical documentation of the approved safety components for lifts and a copy of the EU-type examination certificate. | ||
3. 2. Under the quality system, each safety component for lifts shall be inspected and appropriate tests as set out in the relevant harmonised standards or equivalent tests shall be carried out in order to ensure that it meets the applicable conditions referred to in point 1. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. | ||
It shall contain in particular an adequate description of: | ||
(a) the quality objectives; | ||
(b) the organisational structure, responsibilities and powers of the management with regard to product quality; | ||
(c) the examinations and tests that will be carried out after manufacture; | ||
(d) the means of monitoring the effective operation of the quality system; and | ||
(e) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc. | ||
3. 3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard. | ||
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Schedule 1. | ||
The audit shall include an assessment visit to the manufacturer’s premises. | ||
The auditing team shall review the technical documentation referred to in point 3.1(f), in order to verify the manufacturer’s ability to identify the relevant requirements of the Directive and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements. | ||
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. | ||
3. 4. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient. | ||
3. 5. The manufacturer or his authorised representative shall keep the notified body which has approved the quality system informed of any intended changes of the quality system. | ||
The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. | ||
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. | ||
4. Surveillance under the responsibility of the notified body | ||
4. 1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. | ||
4. 2. The manufacturer shall for assessment purposes allow the notified body access to the premises where final inspection, testing and storage are carried out and provide it with all necessary information, in particular: | ||
(a) the quality system documentation; | ||
(b) the technical documentation; | ||
(c) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned. | ||
4. 3. The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. | ||
4. 4. Additionally, the notified body may pay unexpected visits to the manufacturer’s premises where final inspection and testing of safety components for lifts are carried out. | ||
At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer, with a visit report and, if a test has been carried out, with a test report. | ||
5. CE marking and EU declaration of conformity; | ||
5. 1. The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1. | ||
5. 2. The manufacturer shall draw up a written EU declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. The EU declaration of conformity shall identify the safety component for lifts for which it has been drawn up. | ||
6. The manufacturer shall for a period ending 10 years after the safety component for lifts has been placed on the market, keep at the disposal of the national authorities: | ||
(a) the technical documentation referred to in point 3.1(f); | ||
(b) the documentation referred to in point 3.1(e); | ||
(c) the information relating to the change referred to in point 3.5; | ||
(d) the decisions and reports from the notified body which are referred to in the third paragraph of point 3.5 and in points 4.3 and 4.4. | ||
7. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn and, upon request, of approval decision(s) which it has issued. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued. | ||
8. Authorised representative | ||
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulations 16, 18, 20, 33 and 36 | ||
SCHEDULE 7 | ||
TEXT OF ANNEX VII TO THE DIRECTIVE | ||
CONFORMITY BASED ON FULL QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS | ||
(module H) | ||
1. Conformity based on full quality assurance for safety components for lifts is the conformity assessment procedure whereby a notified body assesses the quality system of a manufacturer to ensure that the safety components for lifts are designed, manufactured, inspected and tested in order to satisfy the applicable requirements of Schedule 1 and to enable a lift to which they are correctly incorporated to satisfy those requirements. | ||
2. Obligations of the manufacturer | ||
The manufacturer shall operate an approved quality system for the design, manufacture, final inspection and testing of safety components for lifts as specified in point 3 and shall be subject to surveillance as specified in point 4. | ||
3. Quality system | ||
3. 1. The manufacturer shall lodge an application for assessment of his quality system with a single notified body of his choice. The application shall include: | ||
(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; | ||
(b) the address of the premises where the safety components for lifts are designed, manufactured, inspected and tested; | ||
(c) all relevant information on safety components for lifts to be manufactured; | ||
(d) the technical documentation described in point 3 of Schedule 4, Part A for one model of each category of safety component for lifts to be manufactured; | ||
(e) the documentation on the quality system; | ||
(f) a written declaration that the same application has not been lodged with any other notified body. | ||
3. 2. The quality system shall ensure compliance of the safety components for lifts with the conditions referred to in point 1. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. | ||
It shall contain in particular an adequate description of: | ||
(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the design and product quality; | ||
(b) the technical design specifications, including standards that will be applied and, where the relevant harmonised standards will not be applied or not applied in full, the means, including other relevant technical specifications, that will be used to ensure that the conditions referred to in point 1 will be met; | ||
(c) the design control and design verification techniques, processes and systematic actions that will be used when designing the safety components for lifts; | ||
(d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; | ||
(e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; | ||
(f) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned; | ||
(g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. | ||
3. 3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard. | ||
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Schedule 1. The audit shall include an assessment visit to the manufacturer’s premises. | ||
The auditing team shall review the technical documentation referred to in point 3.1(d) to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Schedule 1 and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements. | ||
The decision shall be notified to the manufacturer and, where appropriate, to his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision. | ||
3. 4. The manufacturer shall undertake to fullfil the obligations arising from the quality system as approved and maintain it so that it remains adequate and efficient. | ||
3. 5. The manufacturer shall keep the notified body which has approved the quality system informed of any intended change to the quality system. | ||
The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. | ||
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision. | ||
4. Surveillance under the responsibility of the notified body | ||
4. 1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. | ||
4. 2. The manufacturer shall for assessment purposes allow the notified body access to the design, manufacture, inspection and testing, and storage locations, and shall provide it with all necessary information, in particular: | ||
(a) the full quality system documentation; | ||
(b) the quality records provided for in the design part of the quality system such as results of analyses, calculations, tests; | ||
(c) the technical documentation for the safety components for lifts manufactured; | ||
(d) the quality records provided for in the manufacturing part of the full quality system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned. | ||
4. 3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. | ||
4. 4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. | ||
5. CE marking and EU declaration of conformity | ||
5. 1. The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1. | ||
5. 2. The manufacturer shall draw up a written EU declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. The EU declaration of conformity shall identify the safety component for lifts for which it has been drawn up. | ||
6. The manufacturer shall, for a period ending 10 years after the safety component for lifts has been placed on the market, keep at the disposal of the national authorities: | ||
(a) the documentation referred to in point 3.1(e); | ||
(b) the technical documentation referred to in point 3.1(d); | ||
(c) the information relating to the change referred to in the first paragraph of point 3.5; | ||
(d) the decisions and reports from the notified body referred to in the third paragraph of point 3.5. and in points 4.3 and 4.4. | ||
7. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies of quality system approval decisions which it has refused, suspended or withdrawn and, upon request, of approval decisions which it has issued. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued. | ||
The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue. | ||
8. Authorised representative | ||
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulations 17, 18, 20, 33 and 36 | ||
SCHEDULE 8 | ||
TEXT OF ANNEX VIII TO THE DIRECTIVE | ||
CONFORMITY BASED ON UNIT VERIFICATION FOR LIFTS | ||
(module G) | ||
1. Conformity based on unit verification is the conformity assessment procedure whereby a notified body assesses whether a lift complies with the applicable essential health and safety requirements set out in Schedule 1. | ||
2. Obligations of the installer | ||
2. 1. The installer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1. | ||
2. 2. The installer shall apply to a single notified body of his choice for unit verification. | ||
The application shall contain: | ||
(a) the name and address of the installer, and if the application is lodged by the authorised representative, his name and address as well; | ||
(b) the location where the lift is installed; | ||
(c) a written declaration to the effect that a similar application has not been lodged with another notified body; | ||
(d) the technical documentation. | ||
3. The technical documentation shall allow an assessment of the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1. | ||
The technical documentation shall contain at least the following elements: | ||
(a) a description of the lift; | ||
(b) design and manufacturing drawings and diagrams; | ||
(c) explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift; | ||
(d) a list of the essential health and safety requirements taken into consideration; | ||
(e) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; | ||
(f) a copy of the EU-type examination certificates of the safety components for lifts incorporated in the lift; | ||
(g) results of design calculations performed by or for the installer; | ||
(h) test reports; | ||
(i) a copy of the instructions referred to in point 6.2 of Schedule 1. | ||
4. Verification | ||
The notified body chosen by the installer shall examine the technical documentation and the lift and carry out the appropriate tests as set out in the relevant harmonised standard(s), or equivalent tests, to check its conformity with the applicable essential health and safety requirements set out in Schedule 1. The tests shall include at least the tests referred to in point 3.3 of Schedule 5. | ||
If the lift meets the essential health and safety requirements set out in Schedule 1 the notified body shall issue a certificate of conformity relating to the tests carried out. | ||
The notified body shall fill in the corresponding pages of the logbook referred to in point 6.2 of Schedule 1. | ||
If the notified body refuses to issue the certificate of conformity, it shall state in detail its reasons for refusal and indicate the necessary corrective measures to be taken. When the installer reapplies for unit verification he shall apply to the same notified body. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity. | ||
5. CE marking and EU declaration of conformity; | ||
5. 1. The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of the Directive, and, under the responsibility of the notified body referred to in point 2.2, the latter’s identification number adjacent to the CE marking in the car of each lift. | ||
5. 2. The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. | ||
6. The installer shall keep with the technical documentation a copy of the certificate of conformity at the disposal of the national authorities for 10 years from the date on which the lift is placed on the market. | ||
7. Authorised representative | ||
The installer’s obligations set out in points 2.2 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulations 16, 18 and 20 | ||
SCHEDULE 9 | ||
TEXT OF ANNEX IX TO THE DIRECTIVE | ||
CONFORMITY TO TYPE WITH RANDOM CHECKING FORSAFETY COMPONENTS FOR LIFTS | ||
(module C 2) | ||
1. Conformity to type with random checking is the part of the conformity assessment procedure whereby a notified body carries out checks on safety components for lifts to ensure that they are in conformity with the approved type as described in the EU type examination certificate and satisfy the applicable requirements of Schedule 1 and will enable a lift in which they are correctly incorporated to satisfy those requirements. | ||
2. Manufacturing | ||
The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure that the manufactured safety components for lifts meet the conditions referred to in point 1. | ||
3. The manufacturer shall lodge an application for random checking with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; | ||
(b) a written declaration that the same application has not been lodged with any other notified body; | ||
(c) all relevant information on the safety components for lifts manufactured; | ||
(d) the address of the premises where the sample of the safety components for lifts can be taken. | ||
4. The notified body shall carry out or have carried out checks on safety components for lifts at random intervals. An adequate sample of the final safety components for lifts, taken on site by the notified body, shall be examined and appropriate tests set out in the relevant harmonised standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to check whether the safety components for lifts meets the conditions referred to in point 1. In cases where one or more of the safety components for lifts checked do not conform, the notified body shall take appropriate measures. | ||
The points to be taken into account when checking the safety components for lifts will be defined by joint agreement between all the notified bodies responsible for this procedure, taking into consideration the essential characteristics of the safety components for lifts. | ||
The notified body shall issue a certificate of conformity to type with respect to the examinations and tests carried out. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity to type. | ||
5. CE marking and EU declaration of conformity | ||
5. 1. The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1. | ||
5. 2. The manufacturer shall draw up a written EU declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. The EU declaration of conformity shall identify the safety component for lifts for which it has been drawn up. | ||
6. Authorised representative | ||
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative shall not fulfil the manufacturer’s obligations set out in point 2. | ||
Regulations 17, 18 and 20 | ||
SCHEDULE 10 | ||
TEXT OF ANNEX X TO THE DIRECTIVE | ||
CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR LIFTS | ||
(module E) | ||
1. Conformity to type based on product quality assurance is the part of the conformity assessment procedure whereby a notified body assesses the product quality system of an installer to ensure that the lifts are in conformity with the approved type as described in the EU-type examination certificate or with a lift designed and manufactured under a full quality system approved in accordance with Schedule 9, and satisfy the applicable essential health and safety requirements set out in Schedule 1. | ||
2. Obligations of the installer | ||
The installer shall operate an approved quality system for final inspection and testing of the lift as specified in point 3, and shall be subject to surveillance as specified in point 4. | ||
3. Quality system | ||
3. 1. The installer shall lodge an application for assessment of his quality system for the lifts concerned with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the installer, and if the application is lodged by the authorised representative, his name and address as well; | ||
(b) all relevant information on the lifts to be installed; | ||
(c) the documentation on the quality system; | ||
(d) the technical documentation of the lifts to be installed; | ||
(e) a written declaration that the same application has not been lodged with any other notified body. | ||
3. 2. Under the quality system, each lift shall be examined and appropriate tests as set out in the relevant harmonised standards or equivalent tests shall be carried out in order to ensure its conformity with the applicable essential health and safety requirements set out in Schedule 1. | ||
All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and quality records. | ||
It shall contain in particular an adequate description of: | ||
(a) the quality objectives; | ||
(b) the organisational structure, responsibilities and powers of the management with regard to product quality; | ||
(c) the examinations and tests that will be carried out before placing on the market, including at least the tests laid down in point 3.3 of Schedule 5; | ||
(d) the means of monitoring the effective operation of the quality system; | ||
(e) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned. | ||
3. 3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard. | ||
The auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Schedule 1. The audit shall include an assessment visit to the premises of the installer and a visit to the installation site. | ||
The decision shall be notified to the installer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. | ||
3. 4. The installer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient. | ||
3. 4.1. The installer shall keep the notified body which has approved the quality system informed of any intended change to the system. | ||
3. 4.2. The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. | ||
It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision. | ||
The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19. | ||
4. Surveillance under the responsibility of the notified body | ||
4. 1. The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality system. | ||
4. 2. The installer shall, for assessment purposes, allow the notified body access to the installation, inspection and testing locations, and shall provide it with all necessary information, in particular: | ||
(a) the quality system documentation; | ||
(b) the technical documentation; | ||
(c) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc. | ||
4. 3. The notified body shall periodically carry out audits to ensure that the installer maintains and applies the quality system and shall provide the installer with an audit report. | ||
4. 4. Additionally, the notified body may pay unexpected visits to the lift installation sites. | ||
At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system and of the lift. It shall provide the installer with a visit report and, if tests have been carried out, with a test report. | ||
5. The installer shall, for 10 years after the last lift has been installed, keep at the disposal of the national authorities: | ||
(a) the documentation referred to in point 3.1(c); | ||
(b) the technical documentation referred to in point 3.1(d); | ||
(c) the information relating to the changes referred to in point 3.4.1; | ||
(d) the decisions and reports from the notified body which are referred to in the second paragraph of point 3.4.2 and in points 4.3 and 4.4. | ||
6. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions, refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn and, upon request, of approval decision(s) which it has issued. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of quality 7stem approval decision(s) issued. | ||
7. CE marking and EU declaration of conformity | ||
7. 1. The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift. | ||
7. 2. The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. | ||
8. Authorised representative | ||
The installer’s obligations set out in points 3.1, 3.4.1, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulations 17, 18, 20, 33 and 36 | ||
SCHEDULE 11 | ||
TEXT OF ANNEX XI TO THE DIRECTIVE | ||
CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION FOR LIFTS | ||
(module H1) | ||
1. Conformity based on full quality assurance plus design examination for lifts is the conformity assessment procedure whereby a notified body assesses the quality system of an installer and, where appropriate, the design of the lifts, to ensure that the lifts satisfy the applicable essential health and safety requirements set out in Schedule 1. | ||
2. Obligations of the installer | ||
The installer shall operate an approved quality system for the design, manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the lifts shall have been examined in accordance with point 3.3. | ||
3. Quality system | ||
3. 1. The installer shall lodge an application for assessment of his quality system with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the installer, and, if the application is lodged by the authorised representative, his name and address as well; | ||
(b) all relevant information on the lifts to be installed, in particular information which makes for an understanding of the relationship between the design and operation of the lift; | ||
(c) the documentation on the quality system; | ||
(d) the technical documentation described in point 3 of Schedule 4, Part B; | ||
(e) a written declaration that the same application has not been lodged with any other notified body. | ||
3. 2. The quality system shall ensure compliance of the lifts with the applicable essential health and safety requirements set out in Schedule 1. All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and quality records. | ||
It shall contain in particular an adequate description of: | ||
(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; | ||
(b) the technical design specifications, including standards that will be applied and, where the relevant harmonised standards will not be applied in full, the means, including other relevant technical specifications that will be used to ensure that the applicable essential health and safety requirements set out in Schedule 1 will be met; | ||
(c) the design control and design verification techniques, processes and systematic actions that will be used when designing the lifts; | ||
(d) the examinations and tests that will be carried out on acceptance of the supplies of materials, components and sub-assemblies; | ||
(e) the corresponding assembly, installation, quality control and quality assurance techniques, processes and systematic actions that will be used; | ||
(f) the examinations and tests that will be carried out before (inspection of installation conditions: shaft, housing of machinery, etc.), during and after installation (including at least the tests laid down in point 3.3 of Schedule 5); | ||
(g) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned; | ||
(h) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. | ||
3. 3. Design examination | ||
3. 3.1. When the design is not entirely in accordance with harmonised standards, the notified body shall ascertain whether the design conforms to the essential health and safety requirements set out in Schedule 1 and, if it does, issue an EU design examination certificate to the installer, stating the limits of the certificate’s validity and giving the details required for identification of the approved design. | ||
3. 3.2. Where the design does not satisfy the applicable essential health and safety requirements set out in Schedule 1, the notified body shall refuse to issue an EU design examination certificate and shall inform the installer accordingly, giving detailed reasons for its refusal. | ||
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the essential health and safety requirements set out in Schedule 1, and shall determine whether such changes require further investigation. If so, the notified body shall inform the installer accordingly. | ||
3. 3.3. The installer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential health and safety requirements set out in Schedule 1 or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EU design examination certificate — in the form of an addition to the original EU design examination certificate. | ||
3. 3.4. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of EU design examination certificates and/or any additions thereto refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued. | ||
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body. | ||
3. 3.5. The installer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the lift has been placed on the market. | ||
3. 4. Assessment of the quality system | ||
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard. | ||
The auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Schedule 1. The audit shall include an assessment visit to the installer’s premises and a visit to an installation site. | ||
The auditing team shall review the technical documentation referred to in point 3.1(d), to verify the installer’s ability to identify the applicable essential health and safety requirements set out in Schedule 1 and to carry out the necessary examinations with a view to ensuring compliance of the lift with those requirements. | ||
The decision shall be notified to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision. | ||
3. 5. The installer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient. | ||
The installer shall keep the notified body that has approved the quality system informed of any intended change to the system. | ||
The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. | ||
It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision. | ||
The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19. | ||
4. Surveillance under the responsibility of the notified body | ||
4. 1. The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality system. | ||
4. 2. The installer shall, for assessment purposes, allow the notified body access to the design, manufacture, assembly, installation, inspection, testing and storage locations, and shall provide it with all necessary information, in particular: | ||
(a) the quality system documentation; | ||
(b) the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests; | ||
(c) the quality records provided for in the part of the quality system concerning acceptance of supplies and installation, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned. | ||
4. 3. The notified body shall carry out periodic audits to make sure that the installer maintains and applies the quality system and shall provide the installer with an audit report. | ||
4. 4. Additionally, the notified body may pay unexpected visits to the premises of the installer or to the installation site of a lift. At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the installer with a visit report and, if tests have been carried out, with a test report. | ||
5. The installer shall, keep at the disposal of the national authorities for a period ending 10 years after the lift has been placed on the market: | ||
(a) the documentation referred to in point 3.1(c); | ||
(b) the technical documentation referred to in point 3.1(d); | ||
(c) the information relating to the changes referred to in the second paragraph of point 3.5; | ||
(d) the decisions and reports from the notified body which are referred to in the fourth paragraph of point 3.5 and in points 4.3 and 4.4. | ||
6. Each notified body shall inform its notifying authority of full quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn, and, upon request, of approval decisions which it has issued. | ||
The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued. | ||
7. CE marking and EU declaration of conformity | ||
7. 1. The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift. | ||
7. 2. The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. | ||
8. Authorised representative | ||
The installer’s obligations set out in points 3.1, 3.3.3, 3.3.5, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulations 17, 18 and 20 | ||
SCHEDULE 12 | ||
TEXT OF ANNEX XII TO THE DIRECTIVE | ||
CONFORMITY TO TYPE BASED ON PRODUCTION QUALITY ASSURANCE FOR LIFTS | ||
(module D) | ||
1. Conformity to type based on production quality assurance for lifts is the part of the conformity assessment procedure whereby a notified body assesses the production quality system of a installer to ensure that the lifts installed are in conformity with the approved type as described in the EU-type examination certificate or with a lift designed and manufactured under a quality system approved in accordance with Schedule 11, and satisfy the applicable essential health and safety requirements set out in Schedule 1. | ||
2. Obligations of the installer | ||
The installer shall operate an approved quality system for manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4. | ||
3. Quality system | ||
3. 1. The installer shall lodge an application for assessment of his quality system with a single notified body of his choice. | ||
The application shall include: | ||
(a) the name and address of the installer, and, if the application is lodged by the authorised representative, his name and address as well; | ||
(b) all relevant information for the lifts to be installed; | ||
(c) the documentation on the quality system; | ||
(d) the technical documentation of the lifts to be installed; | ||
(e) a written declaration that the same application has not been lodged with any other notified body. | ||
3. 2. The quality system shall ensure compliance of the lifts with the applicable essential health and safety requirements set out in Schedule 1. | ||
All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. | ||
It shall contain in particular an adequate description of: | ||
(a) the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the product quality; | ||
(b) the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; | ||
(c) the examinations and tests that will be carried out before, during and after installation; | ||
(d) the quality records, such as inspection reports and test data, calibration data, reports on the qualification of the personnel concerned; | ||
(e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. | ||
3. 3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. | ||
The auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Schedule 1. | ||
The audit shall include an assessment visit to the installer’s premises and a visit to an installation site. | ||
The decision shall be notified to the installer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. | ||
3. 4. The installer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient. | ||
3. 4.1. The installer shall keep the notified body that has approved the quality system informed of any intended change to the system. | ||
3. 4.2. The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. | ||
It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision. | ||
The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19. | ||
4. Surveillance under the responsibility of the notified body | ||
4. 1. The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality system. | ||
4. 2. The installer shall, for assessment purposes, allow the notified body access to the manufacture, assembly, installation, inspection, testing and storage locations, and shall provide it with all necessary information, in particular: | ||
(a) the quality system documentation; | ||
(b) the technical documentation; | ||
(c) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned. | ||
4. 3. The notified body shall carry out periodic audits to make sure that the installer maintains and applies the quality system and shall provide the installer with an audit report. | ||
4. 4. Additionally, the notified body may pay unexpected visits to the installer. During such visits the notified body may, where necessary carry out tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the installer with a visit report and, if tests have been carried out, with a test report. | ||
5. The installer shall, keep at the disposal of the national authorities for a period ending of 10 years after the lift has been placed on the market: | ||
(a) the documentation referred to in point 3.1(c); | ||
(b) the technical documentation referred to in point 3.1(d); | ||
(c) the information relating to the changes referred to in point 3.4.1; | ||
(d) the decisions and reports from the notified body which are referred to in the second paragraph of points 3.4.2., and in points 4.3 and 4.4. | ||
6. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted. | ||
Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn, and, upon request, of approval decision(s) which it has issued. | ||
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued. | ||
7. CE marking and EU declaration of conformity | ||
7. 1. The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift. | ||
7. 2. The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. | ||
8. Authorised representative | ||
The installer’s obligations set out in points 3.1, 3.4.1, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. | ||
Regulation 2 | ||
SCHEDULE 13 | ||
TEXT OF ANNEX XIV TO THE DIRECTIVE | ||
CORRELATION TABLE | ||
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GIVEN under my Official Seal, | ||
26 May 2017. | ||
MARY MITCHELL O’CONNOR, | ||
Minister for Jobs, Enterprise and Innovation. | ||
EXPLANATORY NOTE | ||
(This note is not part of the Instrument and does not purport to be a legal interpretation.) | ||
The Regulations transpose into national legislation the provisions of Directive 2014/33/EU, which set out the requirements for the making available on the market and putting into service, as well as the essential health and safety requirements relating to the design and installation of lifts and the manufacture of and making available on the market of safety components for lifts. These Regulations also set out the obligations on economic operators in relation to these products and the required conformity assessment procedures for such products. These Regulations also give further effect to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93 and include duties to have proper market surveillance procedures consistent with EU Regulation 765/2008. | ||
The provisions of the Regulations come into immediate effect with the exception of Regulation 7(3) relating to the provisions of a refuge or free space beyond the extreme positions of a lift, which shall come into operation from 1 November 2017. | ||
The Regulations do not impede the making available on the market of products covered by Directive 95/16/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016. | ||
The Regulations revoke and replace the European Communities (Lifts) Regulations 1998, ( S.I. No. 246 of 1998 ) and European Communities (Lifts) (Amendment) Regulations 2008 ( S.I. No. 406 of 2008 ). | ||
1 OJ No. L 96, 29.3.2014, p.251. 2 OJ No. L 218, 13.8.2008, p.30. 3 OJ No. L 213, 7.9.1995, p.1. |