Judgment — ECLI:EU:C:2016:903
Date: 2016-11-24
Language of the case: German
Court formation: Sixth Chamber
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary — Judgment of the Court (Sixth Chamber), 24 November 2016 Approximation of laws — Medical devices –Directive 93/42 — Parallel imports — Addition to the labelling of information relating to the importer — No obligation on the importer to carry out a supplementary conformity assessment of those medical devices (Council Directive 93/42, Arts 1(2)(f), 8(1), 10, 11 and 14b) Article 1(2)(f) and Article 11 of Directive 93/42 concerning medical devices, as amended by Directive 2007/47, must be interpreted as not requiring a parallel importer of a medical device, which bears a CE marking and which has been subjected to a conformity assessment within the meaning of that provision, to carry out a further assessment designed to certify the conformity of the information allowing its identification which that parallel importer adds to the labelling of that device with a view to that device being placed on the market of the Member State of importation. Where a person purchases medical devices in a Member State, after they have been placed on the market in the European Union by their manufacturer, in order then to resell them in another Member State under the manufacturer’s name, without altering their packaging or their original presentation other than by affixing a label designating that person as responsible for placing the devices on the market and indicating its contact details and a code intended to identify those devices, that person cannot be considered to have repackaged or placed those devices on the market ‘under its own name’. In such circumstances, the parallel importer of medical devices, as it is not marketing those devices under its own name, cannot be regarded as coming within the scope of Article 1(2)(f) of Directive 93/42. Consequently, that importer cannot be required to cause the devices in question to undergo a further conformity assessment procedure under Article 11 of that directive. In addition, the combination of the procedures for safeguarding, vigilance and health surveillance, such as laid down in Articles 8(1), 10 and 14b of Directive 93/42, thus ensures protection for the health and safety of persons, while at the same time limiting the adverse effects on the free movement of goods which would be entailed by the application of national measures requiring the importer to carry out an assessment as to the conformity of the alterations which it makes to the labelling of a medical device already bearing a CE marking. (see paras 32, 33, 38, 39, operative part)