STATUTORY INSTRUMENTS

S.I. No. 554 of 2003

EUROPEAN COMMUNITIES (MEDICAL DEVICES) (TISSUES OF ANIMAL ORIGIN) REGULATIONS, 2003

DUBLIN

PUBLISHED BY THE STATIONERY OFFICE

S.I. No. 554 of 2003

EUROPEAN COMMUNITIES (MEDICAL DEVICES) (TISSUES OF ANIMAL ORIGIN) REGULATIONS, 2003

I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 , ( No. 27 of 1972 ) and for the purpose of giving effect to Commission Directive 2003/32/EC of 23 April 2003, hereby make the following Regulations:

Citation and commencement

1.         These Regulations may be cited as the European Communities (Medical Devices) (Tissues Of Animal Origin) Regulations, 2003

2.         These Regulations shall come into force on 1 April 2004.

Definitions

3.         “For the purposes of these Regulations, the following definitions shall apply in addition to the definitions set out in the Principal Regulations:

(a)    “cell” means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;

(b)    “Competent Authority” means the Irish Medicines Board

(c) “derivative” means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;

(d) “Directive 93/42/EEC” means Council Directive No. 93/42/EEC of 14 June 1993¹

(e) “Directive 2003/32/EC” means Commission Directive No 2003/32/EC of 23 April 2003² .

(f) “inactivation” means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;

(g) ”non-viable” means having no potential for metabolism or multiplication;

 (h) ”reduction, elimination or removal” means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;

(i)“Principal Regulations” means the European Communities (Medical Devices) Regulations, 1994 ( S.I. No. 252 of 1994 ) as amended by the European Communities (Medical Devices) (Amendment) Regulations, 2001, ( S.I. No. 444 of 2001 ), European Communities (Medical Devices) (Amendment) Regulations 2002 (SI 576 of 2002), and the European Communities (Medical Devices) (Reclassification of Breast Implants) ( Amendment) Regulations 2003 ( S.I. No 358 of 2003 ).

(j) ”source country” means the country in which the animal was born, has been reared and/or has been slaughtered;

(k) ”starting materials” means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Regulation 5(1) are produced.

(l) “tissue” means an organisation of cells and/or extra-cellular constituents;

(m) “transmissible agents” means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalophathies agents and scrapie agents;

Amendment to Principal Regulations

4          Regulation 2 of the Principal Regulations is amended by substituting for the definition of “the Directive“ the following definition:

“The Directive “ means Council Directive No. 93/42EEC of 1993³ as amended by Council Directives No. 98/79/EC of 1998⁴ , 2000/70/EC of 2000⁵ and 2001/104/EC of 2001⁶ , and Commission Directives No. 2003/12/EC of 2003⁷ and 2003/32/EC of 2003⁸ .

Application

5          (1) These Regulations lay down detailed specifications in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

(2) The animal tissues covered by these Regulations are those originating from bovine, ovine and caprine species, as well as deer, elk, mink and cats.

(3) Collagen, gelatin and tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.

(4) These Regulations do not apply to medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.

Conformity Assessment Procedures

6.         Before lodging an application for a conformity assessment pursuant to Regulation 10 of the Principal Regulations, the manufacturer of medical devices referred to in Regulation 5(1), shall carry out the risk analysis and the risk management scheme set out in the Annex to Directive 2003/32/EC.

7.         (1). Conformity assessment procedures for medical devices referred to in Regulation 5(1), shall include the evaluation of their compliance with the essential requirements of the Principal Regulations and the specifications laid down in the Annex to Directive 2003/32/EC.

(2). Notified bodies shall evaluate the manufacturer's risk analysis and risk management strategy, and in particular:

(a) the information provided by the manufacturer;

(b) the justification for the use of animal tissues or derivatives;

(c) the results of elimination and/or inactivation studies or of literature search;

(d) the manufacturer's control of the sources of raw materials, finished products and subcontractors;

(e) the need to audit matters related to sourcing, including third party supplies.

(3) Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter referred to as the ‘TSE certificate’, for starting materials, where available.

(4) Except for medical devices using starting materials for which a TSE certificate has been issued as referred to in Regulation 7(3) the Competent Authority, shall seek the opinion of the Competent Authorities of the other Member States on their evaluation of and conclusions on the risk analysis and risk management of the tissues or the derivatives intended to be incorporated in the medical device as established by the manufacturer. Before issuing an EC design examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within 12 weeks from the date on which the opinion of the National Competent Authorities was sought.

Placing on the market & putting into service

8.         Medical devices referred to in Regulation 5(1) shall not be placed on the market and put into service unless they comply with the provisions of Directive 93/42/EEC and the specifications laid down in the Annex to Directive 2003/32/EC.

Transitional Arrangements

9.         (1). Holders of EC design-examination certificates of EC type examination certificates issued before 1 April 2004 for medical devices referred to in Regulation 5(1) shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in the Annex to Directive 2003/32/EC.

(2) Until 30 September 2004, medical devices referred to in Regulation 5(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1 April 2004 may be placed on the market and put into service.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation)

These regulations supplement the European Communities (Medical Devices) Regulations, 1994 ( S.I. No. 252 of 1994 ) to give effect to Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications with respect to medical devices manufactured utilising tissues of animal origin,

¹ OJ L 169, 12.7.1993 p1

² OJ L 105, 26.4.2003 p18

³ OJ L 169 12.7.1993 p1

⁴ OJ L 333 7.1.1998 p1

⁵ OJ L 313 13.12.2000 p22

⁶ OJ L 6 10.1.2002 p50

⁷ OJ L 28 4.2.2003 p43

⁸ OJ L 105 26.4.2003 p18