Medical Device Regulations in Europe

Major Regulations
Document Number Published Language
Download IVDR White Paper 12/02/2021
Log in Council Directive 90.385.EEC (AIMDD) 90/385/EEC 06/1990 English
Log in Council Directive 93.42.EEC (MDD) 93/42/EEC 06/1993 English
Log in Council Directive 98.79.EC (IVDD) 98/79/EC 12/2011 English
Log in Regulation (EU) 2017.746 (IVDR) 2017.746 05/2017 English
Log in Regulation (EU) 2017.745 (MDR) 2017.745 05/2017 English
General Guidance Documents
Document Number Published Language
Log in MDCG Guidance Documents English