DIMDI - Medical Devices Law

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

• Gesetz über Medizinprodukte - MPG (The Act on Medical Devices)
• The Act on Medical Devices - Medical Devices Act (PDF, 152 kB)
  non-official translation
• German Regulations Notifications

European Directives (EUR-Lex)

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 Homepage
• Official Journal of the European Union

Guidelines and Standards

• European Commission - Consumer Affairs - Medical Devices
• Guidance MEDDEVs - Guidelines relating to medical devices Directives
• New Approach - Directives and Standards