# C_2006326EN.01005001.xml

| 30.12.2006 | EN | Official Journal of the European Union | C 326/50 |
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30.12.2006

EN

Official Journal of the European Union

C 326/50

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Action brought on 27 November 2006 — Commission of the European Communities v Hellenic Republic

(Case C-489/06)

(2006/C 326/102)

Language of the case: Greek

Parties

Applicant: Commission of the European Communities (represented by: M. Patakia and X. Lewis)

Applicant:

Defendant: Hellenic Republic

Defendant:

Form of order sought

| — | declare that, by rejecting tenders in respect of medical devices bearing the CE certification marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Directive 93/42/EEC, the Hellenic Republic has failed to fulfil its obligations under Article 8(2) of Directive 93/36/EEC of 14 June 1993 (1) coordinating procedures for the award of public supply contracts and Articles 17 and 18 of Council Directive 93/42/EEC of 14 June 1993 (2) concerning medical devices; |
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declare that, by rejecting tenders in respect of medical devices bearing the CE certification marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Directive 93/42/EEC, the Hellenic Republic has failed to fulfil its obligations under Article 8(2) of Directive 93/36/EEC of 14 June 1993 (1) coordinating procedures for the award of public supply contracts and Articles 17 and 18 of Council Directive 93/42/EEC of 14 June 1993 (2) concerning medical devices;

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| — | order the Hellenic Republic to pay the costs. |
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order the Hellenic Republic to pay the costs.

Pleas in law and main arguments

The Commission received a complaint relating to the phenomenon of rejection of medical devices, in the context of calls for competition for supplies to public hospitals in Greece, on grounds relating to the ‘general sufficiency and safety of use’ thereof, notwithstanding their certification with the CE marking, and without, in any event, the procedure provided for in Directive 93/42/EEC concerning medical devices being followed.

Under Directive 93/36/EEC coordinating procedures for the award of public supply contracts, the tender procedures must be conducted on the basis of the relevant national technical standards implementing European standards, of European technical approvals or of common technical specifications. The Commission considers that, by deciding in the instances at issue that the CE marking did not constitute an appropriate and binding guarantee of the suitability of the products in the tenders, without any of the prescribed exceptions which justify divergence from the directive's provisions being applicable, the Greek contracting authorities infringed the obligations owed by them in that regard under Article 8(2).

At the same time, the Commission points out an infringement of Directive 93/42/EEC concerning medical devices, which lays down specific and exclusive procedures for certifying such devices and placing them on the market, as well as for contesting their suitability. The information available to the Commission reveals continual breach, by the competent Greek authorities which have rejected tenders, of the legal procedures for checking the suitability of medical devices. None of the stages of the procedure provided for in Article 18 of the directive was observed where the correctness of certification — pursuant to Article 17 of the directive — with the CE marking was disputed.

Also, in the Commission's submission, the Greek authorities' claim that the measures which they have taken to eliminate the abovementioned phenomenon are sufficient is contradicted by the very facts and, in any event, in accordance with the Court of Justice's case-law, the existence of national procedures which are designed to deal with every infringement relating to public procurement does not justify infringement of the relevant Community rules by the Member State.

The Commission considers therefore that the Hellenic Republic has infringed its obligations under Directive 93/36/EEC, in particular Article 8(2), and under Directive 93/42/EEC, in particular Articles 17 and 18.

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(1)  OJ No L 199, 9.8.1993, p. 1.

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(2)  OJ No L 169, 12.7.1993, p. 1.

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