CELEX: 62015CN0277
Language: en
Date: 2015-06-09 00:00:00
Title: Case C-277/15: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 June 2015 — Servoprax GmbH v Roche Diagnostics Deutschland GmbH

7.9.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 294/28
            
         Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 June 2015 — Servoprax GmbH v Roche Diagnostics Deutschland GmbH
   (Case C-277/15)
   (2015/C 294/34)
   Language of the case: German
   
      Referring court
   
   Bundesgerichtshof
   
      Parties to the main proceedings
   
   
      Appellant on a point of law: Servoprax GmbH
   
      Respondent in the appeal on a point of law: Roche Diagnostics Deutschland GmbH
   
      Questions referred
   
   
               1.
            
            
               In the case of an in vitro diagnostic medical device for self-testing blood sugar levels which has undergone a conformity assessment by the manufacturer in accordance with Article 9 of Directive 98/79/EC (1) in Member State A (specifically: in the United Kingdom), which bears the CE marking of conformity in accordance with Article 16 of that directive and which meets the essential requirements set out in Article 3 of, and Annex I to, that directive, is a third party required to subject that device to a new or additional conformity assessment in accordance with Article 9 of Directive 98/79/EC before it places the device on the market in Member State B (specifically: in the Federal Republic of Germany) in packaging which contains instructions in the official language of Member State B, which differs from the official language of Member State A (specifically: German as opposed to English) and the instructions for the use of which are enclosed in the official language of Member State B rather than in that of Member State A?
            
         
               2.
            
            
               Does it make any difference in this case whether the instructions for use enclosed by the third party correspond word-for-word to the information which the manufacturer of the device uses for the purpose of distribution in Member State B?
            
         
      (1)  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ 1998 L 331, p. 1), as amended by Commission Directive 2011/100/EU of 20 December 2011 (OJ 2011 L 341, p. 50).