(Free movement of goods Directive 93/42/EEC Hospital purchase of medical devices bearing the CE marking Protective measures Public supply contract Contract falling below the threshold of application of Directive 93/36/EEC Principle of equal treatment and obligation of transparency)
- This reference for a preliminary ruling concerns the interpretation of Council Directive 93/36/EEC of 14 June 1993 coordinating procedures for the award of public supply contracts (OJ 1993 L 199, p. 1), as amended by European Parliament and Council Directive 97/52/EC of 13 October 1997 (OJ 1997 L 328, p. 1) ('Directive 93/36'), and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ 2003 L 284, p. 1) ('Directive 93/42').
- The reference was made by the Simvoulio tis Epikratias (Greek Council of State) in the context of proceedings between the company Medipac-Kazantzidis AE ('Medipac') and Venizelio'Pananio (PE.S.Y. KRITIS) ('Venizelio'Pananio'), which is the general hospital of Heraklion, concerning an invitation to tender issued by that hospital and to which that company responded.
Legal context
Community legislation
- Article 5(1) of Directive 93/36 provides:
'(a) Titles II, III and IV and Articles 6 and 7 shall apply to public supply contracts awarded by:
(i) the contracting authorities referred to in Article 1 (b), ... where the estimated value net of value-added tax (VAT) is not less than the equivalent in [euros] of 200 000 special drawing rights (SDRs);
...
(b) This Directive shall apply to public supply contracts for which the estimated value equals or exceeds the threshold concerned at the time of publication of the notice in accordance with Article 9(2);
...
(d) The thresholds laid down in subparagraph (a) and the values of the thresholds expressed in [euros] and in national currencies shall be published in the Official Journal of the European Communities at the beginning of the month of November which follows the revision laid down in the first paragraph of subparagraph (c).'
- The values of the thresholds provided for by the directives governing public contracts applicable as from 1 January 2002 were published in the Official Journal of the European Communities of 27 November 2001 (OJ 2001 C 332, p. 21). A table in point 1 of that notice shows that 200 000 SDR is equivalent to EUR 249 681.
- The 3rd, 5th, 8th, 13th, 17th and 21st recitals in the preamble to Directive 93/42 state:
'Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonised in order to guarantee the free movement of such devices within the internal market;
...
Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive;
...
Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonisation and standardisation ..., rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;
...
Whereas, for the purpose of this Directive, a harmonised standard is a technical specification (European standard or harmonisation document) adopted, on a mandate from the Commission, by either [the European Committee for standardisation (CEN) or by the European Committee for Electrotechnical Standardisation (Cenelec)] or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations ..., and pursuant to the ... [general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984]; ... whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonised standards;
...
Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;
...
Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level'.
- Article 1(1) of Directive 93/42 provides that it is to apply to medical devices and their accessories. For the purposes thereof, accessories are to be treated as medical devices in their own right.
- Under Article 2 of Directive 93/42, Member States are to take all necessary steps to ensure that medical devices may be placed on the market and/or put into service only if they comply with the requirements laid down in that directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.
- Under Article 3 of that directive, medical devices must meet the essential requirements set out in Annex I thereto which apply to them, taking account of their intended purpose.
- Article 4(1) of Directive 93/42 prohibits Member States from creating any obstacle to the placing on the market or the putting into service within their territory of medical devices bearing the CE marking provided for in Article 17 of that same directive which indicates that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11 thereof.
- Under Article 5(1) of Directive 93/42, Member States are to presume compliance with the essential requirements referred to in Article 3 in respect of medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards, the references of which have been published in the Official Journal of the European Communities.
- Article 5(2) provides that, for the purposes of Directive 93/42, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures, the references of which have been published in the Official Journal of the European Communities.
- Article 5(3) of Directive 93/42 refers to Article 6(2) thereof with respect to the procedure to be followed by the Member States where they consider that the harmonised standards do not entirely meet the essential requirements referred to in Article 3 of that directive.
- Article 8 of that directive, entitled 'Safeguard clause', reads as follows:
'1. Where a Member State ascertains that the devices referred to in Article 4(1) and (2) second indent, when correctly installed, maintained and used for their intended purpose, may jeopardise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:
(a) failure to meet the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied;
(c) shortcomings in the standards themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6,
the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the Community.
3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.'
- Article 10 of Directive 93/42 provides:
'1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally:
(a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative established in the Community, is also informed of the incident.
3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which relevant measures have been taken or are contemplated.'
- Article 11 of Directive 93/42 governs the procedure for assessing the conformity of medical devices with the requirements of that directive. To that end, as set out in the 15th recital in the preamble to the directive, medical devices are grouped into four product classes and the tests to which they are subjected are made progressively more stringent based on the vulnerability of the human body and taking account of the potential risks associated with the technical design and manufacture of the devices.
- Article 14b of that directive provides:
'Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States giving the reasons for its decision. The Commission shall, whenever possible, consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).'
- Under Article 17(1) of Directive 93/42, medical devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.
- Under Article 18 of that directive:
'Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.
...'.
- Annex I to Directive 93/42, entitled 'Essential requirements', sets out the following in Part I, entitled 'General requirements':
'1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not jeopardise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
eliminate or reduce risks as far as possible (inherently safe design and construction),
where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
inform users of the residual risks due to any shortcomings of the protection measures adopted.
3. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1(2)(a), as specified by the manufacturer.
...'.
National rules
- Joint Ministerial Decree No DI7/ik.2480, making Greek legislation consistent with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, of 19 August 1994 (FEK B' (Greek Official Journal) 679), transposed that directive into Greek law.
The main proceedings and the questions referred for a preliminary ruling
- By notice No 146/2003 of 8 December 2003, Venizelio-Pananio issued a public invitation to tender, on the basis of lowest price as the award criterion, for the supply of various surgical sutures with a value of EUR 131 500 (including VAT). The notice specified that the sutures had to be certified in accordance with the European Pharmacopoeia and bear the CE marking.
- Medipac was one of the nine companies which submitted a tender. The materials proposed by Medipac bore the required marking.
- On 17 March 2004, the committee conducting the tendering procedure issued a recommendation to Venizelio'Pananio's Administrative Board, reiterating a suggestion from the surgeons of that hospital that the PGA type sutures proposed by Medipac be excluded. According to that recommendation, it had been found that knots done with PGA type materials slipped easily and closed prematurely, that needles frequently twisted or broke and that sutures did not hold sufficiently.
- By Decision No 108 of 24 March 2004, Venizelio-Pananio's Administrative Board stated that the PGA type sutures proposed by Medipac did not meet the technical specifications for the contract and accordingly rejected its tender.
- On 5 April 2004, Medipac submitted an appeal against that rejection decision to Venizelio-Pananio's administration. In its appeal, it stated, inter alia, that the technical specifications on which the rejection of its tender was based had not been set out in the invitation to tender, were imprecise to the point of being incomprehensible, did not permit a proper assessment of the requirements relating to the materials to be supplied, and diverged from the technical characteristics for such materials referred to in Directive 93/42. Medipac also maintained that the materials it proposed, which comply with the requirements of the European Pharmacopoeia, did not and could not have the technical imperfections referred to by the hospital. The hospital rejected the appeal by an initial decision of 7 April 2004, which was subsequently repealed and replaced by a second decision adopted on 28 April 2004.
- An action against that rejection decision has been brought before the Simvoulio tis Epikratias. In its action, Medipac puts forward the same reasons that it had raised in its appeal.
- In those circumstances, the Simvoulio tis Epikratias decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
'(1) Whenever tender procedures governed by ... Directive 93/36/EEC for the supply of medical devices under Directive 93/42/EEC are conducted under the lowest-price system, is the contracting authority as the purchaser of the relevant goods able, in accordance with Directive 93/42/EEC, interpreted in conjunction with Directive 93/36/EEC, to reject a tender for medical devices which bear the CE marking and have been the subject of a quality check by the competent certification body, as technically unacceptable at the stage of the technical assessment, in reliance upon sound objections relating to their adequacy in terms of quality which are connected with the protection of public health and the specific form of use for which those devices are intended and in view of which objections the devices are considered inappropriate and unfit for that use (with the self-evident precondition that those objections are subject to review of their validity by the court having jurisdiction if there is a dispute as to whether they pertain)?
(2) If the preceding question is answered in the affirmative, is the contracting authority as the purchaser of the relevant goods able, for the foregoing reason, directly to consider medical devices which bear the CE marking unsuitable for the form of use for which they are intended, or must the safeguard clauses first be applied which are contained in Directive 93/42/EEC and the ... Joint Ministerial Decree DI7/ik.2480/1994 and which enable the relevant competent authority which in Greece is the Ministry of Health, Welfare and Social Security acting through the Directorate for Biomedical Technology to take measures either in accordance with the procedure in Article 8 of the directive, if correctly installed and maintained medical devices may jeopardise the life or safety of patients or users, or under Article 18 of the directive, if it is established that the CE marking has been affixed unduly?
(3) In the light of the answer to the second question, and in the event that the abovementioned safeguard clauses must first be applied, is the contracting authority obliged to await the outcome of the procedure initiated either under Article 8 or under Article 18 of Directive 93/42/EEC and, further, is it bound by that outcome in the sense that it is obliged to procure the article in question even though its use demonstrably gives rise to risks for public health and generally it is unsuitable for the use for which the contracting authority intends it?'
Admissibility of the reference for a preliminary ruling
Arguments of the Austrian Government
- The Austrian Government considers that the answer to the questions referred by the national court is not liable to help that court adjudicate on the main proceedings and that the reference for a preliminary ruling is accordingly inadmissible. First, those questions relate expressly to the interpretation of Directive 93/36, but the tendering procedure at issue in the main proceedings does not fall within the scope of application of that directive, since the amount of the contract under the invitation to tender is lower than the threshold laid down in Article 5 of that directive.
- Second, the reference for a preliminary ruling does not contain the information necessary for the Court to be able to answer the questions referred in a manner that will be helpful to the continuation of the main proceedings. The Austrian Government observes that the reference does not state whether the surgical sutures in question really are considered to be dangerous for human health or whether they simply do not meet the qualitative expectations of the surgeons concerned, which is a crucial factor in the assessment of the rights and obligations of the contracting authority.
Findings of the Court
- Regarding, in the first place, the applicability of Directive 93/36, it is common ground that it applies only to contracts the value of which is equal to or greater than the threshold laid down in Article 5(1) of that directive (see, to that effect, order in Case C-59/00 Vestergaard [2001] ECR I-9505, paragraph 19). The file shows that the value of the contract at issue in the main proceedings is EUR 131 500 (including VAT), which is lower than the threshold of application laid down in that directive.
- In those circumstances, the Court, pursuant to Article 104(5) of its Rules of Procedure, made a written request for clarifications from the national court as to the reasons why it considered that Directive 93/36 was applicable to the contract. That court replied that, for procedural reasons, it was not able to answer such a request. Consequently, the Court decided to hold a hearing, during which the Greek Government confirmed that the value of the contract was lower than the threshold for application of that directive and maintained that the directive did not apply to the main proceedings. The Court accordingly finds that the Austrian Government is correct in arguing that, in those circumstances, an interpretation of Directive 93/36 has no bearing on the outcome of those proceedings.
- However, a useful reply to the questions referred by the national court calls for the consideration of certain general principles applicable to public procurement.
- The Court notes that the national court has categorised Venizelio-Pananio as a 'contracting authority'. That classification is also accepted by the Greek Government, which stated at the hearing that that hospital is a body governed by public law equated with the State. According to settled case-law, even if the value of a contract which is the subject-matter of an invitation to tender does not attain the threshold of application of the directives by which the Community legislature has regulated the field of public procurement, and the contract in question therefore does not fall within the scope of application of those directives, contracting authorities awarding contracts are nevertheless bound to abide by the general principles of Community law, such as the principle of equal treatment and the resulting obligation of transparency (see, to that effect, Case C-324/98 Telaustria and Telefonadress [2000] ECR I-10745, paragraphs 60 and 61; order in Vestergaard, paragraphs 20 and 21; Case C-231/03 Coname [2005] ECR I-7287, paragraphs 16 and 17, and Case C-458/03 Parking Brixen [2005] ECR I-8585, paragraphs 46 to 48).
- Admittedly, the national court does not refer directly in its reference for a preliminary ruling to the general principles of Community law. It is settled case-law, however, that in order to provide a satisfactory answer to a national court which has referred a question to it, the Court may deem it necessary to consider rules of Community law to which the national court has not referred in its reference (Case 35/85 Tissier [1986] ECR 1207, paragraph 9; Case C-315/88 Bagli Pennacchiotti [1990] ECR I-1323, paragraph 10; Case C-107/98 Teckal [1999] ECR I-8121, paragraph 39, and Telaustria and Telefonadress, paragraph 59).
- Second, regarding the Austrian Government's line of argument relating to insufficient information on the facts of the main proceedings, the Court notes that the information contained in the reference for a preliminary ruling has been supplemented by the written observations submitted to the Court. Moreover, an audience has been held, which has enabled the Greek and Austrian Governments and the Commission to submit additional observations. The Court is thus sufficiently enlightened to be able to respond to the questions referred.
- In the light of the foregoing, the Court finds that the reference for a preliminary ruling is admissible and that it is appropriate to reply to the questions referred by the national court.
The questions referred for a preliminary ruling
The first and second questions
- By its first and second questions, which are closely linked and must be examined together, the national court asks, essentially, whether under the general principles of Community law applicable to tendering procedures, a contracting authority which has initiated such a procedure with a view to purchasing medical devices may directly exclude a tender for products for reasons relating to the protection of public health although those products bear the CE marking as required by the specifications of the invitation to tender, or whether that authority is required first to apply the safeguard clauses provided for in Articles 8 and 18 of Directive 93/42.
Observations submitted to the Court
- With regard to Directive 93/42, Medipac states that Member States may not prohibit, restrict or impede the placing on the market of medical devices which satisfy the provisions of that directive and which bear the CE marking. It maintains, as does the Commission, that a combined reading of Articles 3 and 17 of Directive 93/42 indicates that medical devices bearing that marking satisfy all compliance and safety requirements as laid down in Annex I to that directive. It follows that that directive introduces a presumption of compliance for products bearing the CE marking which may be rebutted only in the context of the safeguard procedure referred to in Articles 8 and 18.
- Venizelio-Pananio and the Greek and Austrian Governments state that Directive 93/42 is intended to ensure that medical devices offer a high level of protection to patients, users and third parties. They infer therefrom that if a tender for medical devices certified in accordance with that directive is however inadequate from a technical standpoint, a contracting authority is entitled to exclude those devices directly from the tendering procedure. The Austrian Government adds, however, that the contracting authority is bound to inform the competent national authority of that exclusion so that the latter may take appropriate interim measures and commence the procedure provided for in Article 8 of that directive.
- The Greek Government adds that Directive 93/42 in principle lays down only minimum requirements to be satisfied by a medical device in order to be able to bear the CE marking within the Community. The Austrian Government states that a contracting authority is free to impose qualitative requirements which go beyond the minimum required at Community level.
Findings of the Court
- The Court finds as a preliminary point that the file does not show that, in the main proceedings, the contracting authority imposed particular requirements going beyond the minimum required by Community law.
- It follows from the provisions referred to in paragraphs 5 to 19 of this judgment that Directive 93/42 harmonises the essential requirements to be met by medical devices falling within its scope of application. Once those devices comply with the harmonised standards and are certified in accordance with the procedures provided for by that directive, they must be presumed to comply with those essential requirements and therefore be deemed to be appropriate for the use for which they are intended. Those medical devices must also be allowed to circulate freely throughout the Community.
- It follows from the Court's settled case-law that the obligations arising from Community directives are binding, inter alia, on bodies or entities which are subject to the authority or control of a public authority or the State (see, to that effect, Case 152/84 Marshall [1986] ECR 723, paragraph 49; Case 103/88 Fratelli Costanzo [1989] ECR 1839, paragraphs 30 and 31; Case C-188/89 Foster and Others [1990] ECR I-3313, paragraph 18; order in Case C-297/03 Sozialhilfeverband Rohrbach [2005] ECR I-4305, paragraph 27). Consequently, the obligation to presume that medical devices which meet the harmonised standards and bear the CE marking comply with the requirements of Directive 93/42 extends to Venizelio'Pananio in its capacity as a body governed by public law.
- The Court notes, however, as pointed out by the Advocate General in point 92 of her Opinion, that the presumption of compliance of medical devices may be rebutted. In that respect, Directive 93/42 provides for the implementation of safeguard measures where a finding is made that certain medical devices bearing the CE marking may nevertheless pose risks for patients or users.
- Article 10 of that directive provides that Member States are to take the necessary steps to ensure that information relating to incidents occurring after the placing on the market of medical devices which may pose a risk for the health of a patient or a user are recorded and evaluated centrally. If, following such an evaluation, Member States take or contemplate taking measures, they must inform the Commission immediately.
- Article 8(1) of Directive 93/42 requires Member States which have found there to be risks linked to medical devices which have been certified as being in compliance with that directive to take all appropriate interim measures to withdraw those medical devices from the market or prohibit or restrict their being placed on the market or put into service. In those circumstances, the Member State concerned is required by that same provision to notify the Commission immediately of the measures taken, indicating in particular the reasons for the measures. Under Article 8(2) of Directive 93/42, the Commission must in turn examine whether those interim measures are justified and, if so, inform immediately the Member State which initiated such measures and the other Member States.
- Under Article 8(3) of Directive 93/42, where a medical device bearing the CE marking nevertheless does not comply with the essential requirements provided for by that directive, the Member State concerned is to take appropriate action and to inform the Commission and the other Member States. Moreover, Article 18 of that same directive provides that where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the Community is to be obliged to end the infringement under conditions imposed by the Member State.
- It is clear from the wording of Article 8(1) of that directive that the obligations provided for therein are imposed on a body on which the Member State has conferred competence to ascertain the risks which devices which comply with that directive may nevertheless pose for public health and/or safety and to take, where necessary, measures of general application provided for by that article in order to deal with the situation.
- Since Venizelio-Pananio clearly was not given such competence by the Greek State, it is not entitled to implement on its own the safeguard measures referred to in Article 8 of Directive 93/42. It follows that, once that hospital had doubts as to the technical reliability of the surgical sutures proposed by Medipac, it was required, by virtue of the obligation imposed on it as an entity governed by public law, to assist in the correct application of Directive 93/42, to inform the competent national authority so that the latter could conduct its own checks and, where necessary, implement such safeguard measures. The file shows that in the main proceedings Venizelio-Pananio did refer the question of the appropriateness of the sutures for their intended use to the Greek national body overseeing medicinal products and that the latter confirmed that they complied with the standards in force. That reference was made only on 5 May 2004, however, that is, after the hospital had rejected Medipac's tender. Venizelio-Pananio thus rebutted the presumption of compliance of its own motion, without following the safeguard procedure introduced by the abovementioned directive.
- However, not only the wording of Article 8 of Directive 93/42 but also the purpose of the harmonisation system established by it preclude a contracting authority from being entitled to reject, outside that safeguard procedure and on grounds of technical inadequacy, medical devices which are certified as being in compliance with the essential requirements provided for by that directive.
- Directive 93/42, in so far as it amounts to a harmonisation measure adopted pursuant to Article 100a of the EEC Treaty (which became Article 100a of the EC Treaty, itself now, after amendment, Article 95 EC), is intended to promote the free movement of medical devices which have been certified as being in compliance with that directive, precisely by replacing the various measures taken in this field in the Member States, which may amount to an obstacle to that free movement.
- In that context, the need to reconcile the free movement of those devices with the protection of patients' health implies that, in the event of the emergence of a risk linked to devices which have been certified as being in compliance with Directive 93/42, the Member State concerned must implement the safeguard procedure provided for in Article 8 of that directive; bodies which are not empowered to do so may not themselves decide unilaterally on the action to be taken in such circumstances.
- Moreover, where proposed products, although bearing the CE marking, give rise to concern on the part of the contracting authority as to patients' health or safety, the principle of equal treatment of tenderers and the obligation of transparency, which apply irrespective of whether Directive 93/36 is applicable, preclude, in order to avoid arbitrariness, the contracting authority from being able itself to reject the tender in question directly and requires it to follow a procedure, such as the safeguard procedure provided for in Article 8 of Directive 93/42, which is such as to ensure objective and independent assessment and checking of the alleged risks.
- Moreover, that principle and that obligation prohibit the contracting authority from rejecting a tender which satisfies the requirements of the invitation to tender on grounds which are not set out in the tender specifications and which are relied on subsequent to the submission of the tender.
- In the light of the foregoing, the answer to the first and second questions must be that the principle of equal treatment and the obligation of transparency preclude a contracting authority, which has issued an invitation to tender for the supply of medical devices and specified that those devices must comply with the European Pharmacopoeia and bear the CE marking, from rejecting, directly and without following the safeguard procedure provided for in Articles 8 and 18 of Directive 93/42, on grounds of protection of public health, the materials proposed, if they comply with the stated technical requirement. If the contracting authority considers that those materials may jeopardise public health, it is required to inform the competent national authority with a view to setting that safeguard procedure in motion.
The third question
- By its third question, the national court asks the Court how the safeguard measures provided for by Directive 93/42 must be implemented by a contracting authority in the context of an ongoing tendering procedure. It asks in particular whether the contracting authority must await the end of the safeguard procedure and whether it is bound by the outcome of that procedure.
- As evidenced by the answer given to the first and second questions, a contracting authority is entitled to reject a tender for medical devices bearing the CE marking, on grounds of technical inadequacy, only in the context of the safeguard procedure provided for by Directive 93/42.
- More specifically, a contracting authority's power to reject the tender for medical devices bearing the CE marking on grounds of technical inadequacy is subject to the outcome of the safeguard procedure, namely the Commission's decision establishing, in accordance with Article 8(2) of that directive, that the adoption of measures prohibiting the placing on the market or putting into service of the devices is justified.
- It follows that a contracting authority, once it has decided to refer the matter to the competent national authority, is required to suspend the award procedure so as to set in motion the safeguard procedure provided for by Directive 93/42 and to await the end of the latter procedure. The Commission's decision is binding on the contracting authority. If the safeguard procedure were to lead to a finding that those materials do not comply with the requirements of that directive, the measures of general application taken by the Member State would entail the exclusion of those products from the award procedure which was suspended.
- The suspension of a tendering procedure for the supply of medical devices may, of course, lead to delays liable to give rise to problems in running a hospital such as Venizelio-Pananio. However, as pointed out by the Advocate General in point 118 of her Opinion and pursuant to Article 14b of Directive 93/42, the objective of the protection of public health constitutes an overriding public-interest requirement entitling Member States to derogate from the principle of the free movement of goods provided that the measures taken comply with the principle of proportionality (see Case 120/78 Rewe'Zentral [1979] ECR 649 ('Cassis de Dijon'), paragraph 8; Case C-270/02 Commission v Italy [2004] ECR I-1559, paragraphs 21 and 22; and Joined Cases C-158/04 and C-159/04 Alfa Vita Vassilopoulos and Carrefour-Marinopoulos [2006] ECR I-8135, paragraphs 20 to 23).
- Consequently, in a situation of urgency, a hospital such as Venizelio-Pananio is entitled to take all interim measures required to enable it to procure the medical devices necessary for its operation. In such cases, however, it must be able to show that there is a situation of urgency justifying such a derogation from the principle of free movement of goods and demonstrate that the measures taken are proportionate.
- In the light of the foregoing, the answer to the third question must be that a contracting authority, which has referred a matter to the competent national authority with a view to setting in motion the safeguard procedure provided for by Articles 8 and 18 of Directive 93/42 concerning medical devices bearing the CE marking, is required to suspend the tendering procedure until the end of that safeguard procedure, the outcome of that procedure being binding on the contracting authority. If the implementation of such a safeguard procedure gives rise to delays liable to jeopardise the operation of a public hospital and thereby public health, the contracting authority is entitled to take all interim measures required to enable it to procure the materials necessary for the smooth running of that hospital, subject to compliance with the principle of proportionality.
Costs
- Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.
On those grounds, the Court (First Chamber) hereby rules:
1. The principle of equal treatment and the obligation of transparency preclude a contracting authority, which has issued an invitation to tender for the supply of medical devices and specified that those devices must comply with the European Pharmacopoeia and bear the CE marking, from rejecting, directly and without following the safeguard procedure provided for in Articles 8 and 18 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, on grounds of protection of public health, the materials proposed, if they comply with the stated technical requirement. If the contracting authority considers that those materials may jeopardise public health, it is required to inform the competent national authority with a view to setting that safeguard procedure in motion.
2. A contracting authority, which has referred a matter to the competent national authority with a view to setting in motion the safeguard procedure provided for by Articles 8 and 18 of Directive 93/42, as amended by Regulation No 1882/2003, concerning medical devices bearing the CE marking, is required to suspend the tendering procedure until the end of that safeguard procedure, the outcome of that procedure being binding on the contracting authority. If the implementation of such a safeguard procedure gives rise to delays liable to jeopardise the operation of a public hospital and thereby public health, the contracting authority is entitled to take all interim measures required to enable it to procure the materials necessary for the smooth running of that hospital, subject to compliance with the principle of proportionality.
[Signatures]
* Language of the case: Greek.
