# C_2005069EN.01000701.xml

| 19.3.2005 | EN | Official Journal of the European Union | C 69/7 |
| --- | --- | --- | --- |

19.3.2005

EN

Official Journal of the European Union

C 69/7

---

Reference for a preliminary ruling from the Simvoulio tis Epikratias by decision of that court of 17 November 2004 in Medipac — Th. Kazantzidis A.E. v Venizelio-Pananio (PE.S.I. Kritis)

(Case C-6/05)

(2005/C 69/14)

Language of the case: Greek

Reference has been made to the Court of Justice of the European Communities by decision of the Simvoulio tis Epikratias (Council of State, Greece) of 17 November 2004, received at the Court Registry on 5 January 2005, for a preliminary ruling in the proceedings between Medipac — Th. Kazantzidis A.E. and Venizelio-Pananio (PE.S.I. Kritis) on the following questions:

| (1) | Whenever tender procedures governed by Council Directive 93/36/EEC for the supply of medical devices under Directive 93/42/EEC are conducted under the lowest-tender system, is the contracting authority as the purchaser of the relevant goods able, in accordance with Directive 93/42, interpreted in conjunction with Directive 93/36, 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)? |
| --- | --- |

(1)

Whenever tender procedures governed by Council Directive 93/36/EEC for the supply of medical devices under Directive 93/42/EEC are conducted under the lowest-tender system, is the contracting authority as the purchaser of the relevant goods able, in accordance with Directive 93/42, interpreted in conjunction with Directive 93/36, 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 and the abovementioned 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? |
| --- | --- |

(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 and the abovementioned 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 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 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? |
| --- | --- |

(3)

In 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 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?

---