EU-Regulations and Directives
EU-Directives
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
(EUR-Lex)
Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
(EUR-Lex)
EU-Regulations
Council Directive 93/42/EEC
concerning medical devices (EUR-Lex)
Directive 98/79/EC
of the European Parliament and of the Council on in vitro diagnostic medical devices (EUR-Lex)
Directive 2000/70/EC
of the European Parliament and of the Council amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (EUR-Lex)
Directive 2001/104/EC
of the European Parliament and of the Council amending Council Directive 93/42/EEC concerning medical devices (EUR-Lex)
Directive 2001/95/EC
of the European Parliament and of the Council on general product safety (EUR-Lex)
Commission Decision of 7 May 2002
on common technical specifications for in vitro-diagnostic medical devices (EUR-Lex)
Commission Directive 2003/12/EC
on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (EUR-Lex)
Directive 2002/95/EC
of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EUR-Lex)
Commission Directive 2003/32/EC
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 (EUR-Lex)
Commission Directive 2005/50/EC
on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (EUR-Lex)
Directive 2007/47/EC
of the European Parliament and of the Council 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 (EUR-Lex)
Commission Directive 2011/100/EU
amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices (EUR-Lex)