Opinion of the Advocate General — ECLI:EU:C:2006:724
Date: 2006-11-21
Language of the case: Greek
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Greece

Summary of the Judgment 1. Approximation of laws – Medical devices – Directive 93/42 (Council Directive 93/42, as amended by European Parliament and Council Regulation No 1882/2003) 2. Approximation of laws – Medical devices – Directive 93/42 (Council Directive 93/42, as amended by European Parliament and Council Regulation No 1882/2003) 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 to a public hospital 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 concerning medical devices, as amended by Regulation No 1882/2003, 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. (see para. 55, operative part 1) 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 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. (see para. 62, operative part 2)