CELEX: 62015CN0219
Language: en
Date: 2015-05-13 00:00:00
Title: Case C-219/15: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 13 May 2015 — Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH

24.8.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 279/17
            
         Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 13 May 2015 — Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH
   (Case C-219/15)
   (2015/C 279/21)
   Language of the case: German
   
      Referring court
   
   Bundesgerichtshof
   
      Parties to the main proceedings
   
   
      Applicant: Elisabeth Schmitt
   
      Defendant: TÜV Rheinland LGA Products GmbH
   
      Questions referred
   
   Is it the purpose and intention of the Directive (1) that, in the case of Class III medical devices, the notified body responsible for auditing the quality system, examining the design of the product and surveillance acts in order to protect all potential patients and may therefore, in the event of a culpable infringement of an obligation, have direct and unlimited liability towards the patients concerned?
   Does it follow from the aforementioned points of Annex II to Directive 93/42/EEC that, in the case of Class III medical devices, the notified body responsible for auditing the quality system, examining the design of the product and surveillance is subject to a general obligation to examine devices, or at least to examine them where there is due cause?
   Does it follow from the aforementioned points of Annex II to Directive 93/42/EEC that, in the case of Class III medical devices, the notified body responsible for auditing the quality system, examining the design of the product and surveillance is subject to a general obligation to examine the manufacturer’s business records and/or to carry out unannounced inspections, or at least to do so where there is due cause?
   
      (1)  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ 2007 L 247, p. 21).