Medical Device Regulations in Europe

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

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Major Regulations
Document Number Published Language
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