Medical Device Regulations in Europe

Log into RAMS to download the documents listed below along with more regulations and guidances for the European Union.


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