Medical Device Regulations in Europe
Log into RAMS to download the documents listed below along with more regulations and guidances for the European Union.
| 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 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | MDCG Guidance Documents | English |
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