CELEX: 62015CA0662
Language: en
Date: 2016-11-24 00:00:00
Title: 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)

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.