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Case C-662/15: 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 (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)
ECLI:EU:UNKNOWN:62015CA0662
62015CA0662
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30.1.2017
Official Journal of the European Union
C 30/14
(Case C-662/15) (<a id="ntc1-C_2017030EN.01001401-E0001" href="#ntr1-C_2017030EN.01001401-E0001"> (<span class="super note-tag">1</span>)</a>)
((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
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.
Language of the case: German
(<a id="ntr1-C_2017030EN.01001401-E0001" href="#ntc1-C_2017030EN.01001401-E0001">(<span class="super">1</span>)</a> <a href="./../../../../legal-content/EN/AUTO/?uri=OJ:C:2016:118:TOC">OJ C 118, 4.4.2016</a>.)
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