Opinion of the Advocate General — ECLI:EU:C:2008:638
Date: 2008-11-20
Language of the case: Greek
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Action for failure to fulfil obligations - successful
Origin: Greece

Summary of the Judgment 1. Approximation of laws – Medical devices – Directive 93/42 (Council Directives 93/36, as amended by Directive 2001/78, Art. 8(2), and 93/42, as amended by Regulation No 1882/2003, Arts 8, 17 and 18) 2. Actions for failure to fulfil obligations – Proof of failure – Burden of proof on Commission – Presumptions – Not permissible – Failure to fulfil obligations arising from an administrative practice contrary to Community law (Art. 226 EC) 1. Contracting authorities which have issued an invitation to tender for the supply of medical devices bearing the CE marking cannot reject, on grounds of protection of public health, the tender in respect of such products, directly and without following the safeguard procedure provided for in Articles 8 and 18 of Directive 93/42 concerning medical devices, as amended by Regulation No 1882/2003. If a contracting authority considers that the tender in respect of medical devices bearing the CE marking may compromise public health, it is required to inform the competent authority with a view to setting that safeguard procedure in motion. In that context, a practice of the contracting authorities, which demonstrates a certain degree of consistency and generality, consisting of rejecting tenders in respect of medical devices bearing the CE certification marking, without the procedure provided for in Directive 93/42 being respected amounts to a failure on the part of a Member State to fulfil its obligations under Article 8(2) of Directive 93/36 coordinating procedures for the award of public supply contracts, as amended by Directive 2001/78, and Articles 17 and 18 of Directive 93/42. (see paras 43, 53, 56) 2. In proceedings under Article 226 EC for failure to fulfil obligations, in order for a failure to fulfil obligations to be found on the basis of the administrative practice followed in a Member State, the failure to fulfil obligations can be established only by means of sufficiently documented and detailed proof of the alleged practice; that practice must be, to some degree, of a consistent and general nature; and, in order to find that there has been a general and consistent practice, the Commission may not rely on any presumption. Where the Commission has adduced sufficient evidence to show that a Member State’s authorities have developed a repeated and persistent practice which is contrary to the provisions of a directive, it is incumbent on that Member State to challenge in substance and in detail the information thus produced and the consequences flowing therefrom. (see paras 48, 54)