30.1.2017
EN
Official Journal of the European Union
C 30/14
Judgment of the Court (Sixth Chamber) of 24 November 2016 (request for a preliminary ruling from the Oberlandesgericht Düsseldorf — Germany) — Lohmann & Rauscher International GmbH & Co. KG v BIOS Medical Services GmbH, formerly BIOS Naturprodukte GmbH
(Case C-662/15) (1)
((Reference for a preliminary ruling - Approximation of laws - Directive 93/42/EEC - Medical devices - Class I device (sterile wound dressings) which has been the subject of a conformity assessment procedure by the manufacturer - Parallel imports - Addition to the labelling of information relating to the importer - Supplementary conformity assessment procedure))
(2017/C 030/15)
Language of the case: German
Referring court
Oberlandesgericht Düsseldorf
Parties to the main proceedings
Applicant: Lohmann & Rauscher International GmbH & Co. KG
Defendant: BIOS Medical Services GmbH, formerly BIOS Naturprodukte GmbH
Operative part of the judgment
Article 1(2)(f) and Article 11 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, must be interpreted as not requiring a parallel importer of a medical device, such as that at issue in the main proceedings, which bears a CE marking and which has been subjected to a conformity assessment within the meaning of that Article 11, 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.
(1) OJ C 118, 4.4.2016.
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