Medipac-Kazantzidis AE v Venizeleio-Pananeio (PE.S.Y. KRITIS).
Date: 2007-06-14
33. 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).
34. 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).
42. 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.
43. 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.
46. 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.
47. 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.
51. 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.
52. 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.
54. 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.
55. 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
60. 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).