EU-MDR
Regulation on medical devices
European Union regulation establishing requirements for medical devices placed on the EU market. Defines classification rules, conformity assessment procedures, clinical evaluation requirements, and post-market surveillance obligations. Replaces Directive 93/42/EEC.
- Document
- Regulation (EU) 2017/745
- URL
- https://eur-lex.europa.eu/eli/reg/2017/745/oj
- Label
- Regulation
- Keywords
- medical device regulation EU classification conformity assessment clinical evaluation post-market surveillance CE marking
Domain: Medical · Regulation