CELEX: 62015CA0277
Language: en
Date: 2016-10-13 00:00:00
Title: Case C-277/15: Judgment of the Court (First Chamber) of 13 October 2016 (request for a preliminary ruling from the Bundesgerichtshof — Germany) — Servoprax GmbH v Roche Diagnostics Deutschland GmbH (Reference for a preliminary ruling — Approximation of laws — In vitro diagnostic medical devices — Directive 98/79/EC — Parallel imports — Translation by the importer of the information and instructions for use provided by the manufacturer — Supplementary conformity assessment procedure)

12.12.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 462/6
            
         Judgment of the Court (First Chamber) of 13 October 2016 (request for a preliminary ruling from the Bundesgerichtshof — Germany) — Servoprax GmbH v Roche Diagnostics Deutschland GmbH
   (Case C-277/15) (1)
   
   ((Reference for a preliminary ruling - Approximation of laws - In vitro diagnostic medical devices - Directive 98/79/EC - Parallel imports - Translation by the importer of the information and instructions for use provided by the manufacturer - Supplementary conformity assessment procedure))
   (2016/C 462/08)
   Language of the case: German
   
      Referring court
   
   Bundesgerichtshof
   
      Parties to the main proceedings
   
   
      Applicant: Servoprax GmbH
   
      Defendant: Roche Diagnostics Deutschland GmbH
   
      Operative part of the judgment
   
   Article 9 of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices must be interpreted as meaning that it does not require a parallel importer of a device for self-diagnosis for measuring blood sugar that bears a CE marking and that was the subject of a conformity assessment by a notified body to undertake a further assessment in order to certify the conformity of the labelling of that device and the instructions for its use as a result of their translation into the official language of the Member State of importation.
   
      (1)  OJ C 294, 7.9.2015.