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Medical Devices Law

EUR-Lex - the access to European Union law - and the European Commission - DG for Enterprise and Industry offer an overall view on medical devices, e.g. Directives, Guidelines, harmonised standards and other important documents.

German Laws

European Directives

EUR-Lex provides direct access to European Union law including the Official Journal of the European Union.

  • 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
  • Council Directive 93/42/EEC
    of 14 June 1993 concerning medical devices
  • Directive 2000/70/EC (PDF, 106 kB)
    of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2001/104/EC (PDF, 95 kB)
    of the European Parliament and of the Council of 7. December 2001 amending Council Directive 93/42/EEC concerning medical devices
  • Commission Directive 2003/32/EC (PDF, 123 kB)
    of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin
  • Council Directive 90/385/EEC
    of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
  • Directive 98/79/EC
    of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

EUR-Lex

Guidelines and Standards