Standards, Legislation and other related documents

Regulations

Directives and Recommendations

  • German Ministry of Health (BMG) – Publication On Unannounced Audits
  • Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending the 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
  • Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
  • Directive 2000/70/EC 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
  • 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

Guidelines

Medical Device Single Audit Program (MDSAP) – Documents

CoC – Code of Conduct for Notified Bodies