EU-IVDR
Regulation on in vitro diagnostic medical devices
EU regulation for in vitro diagnostic (IVD) medical devices. Establishes classification rules, performance evaluation requirements, and conformity assessment procedures for diagnostics including companion diagnostics and self-testing devices. Replaces Directive 98/79/EC.
- Document
- Regulation (EU) 2017/746
- URL
- https://eur-lex.europa.eu/eli/reg/2017/746/oj
- Label
- Regulation
- Keywords
- in vitro diagnostics IVD EU regulation companion diagnostics self-testing conformity assessment performance evaluation
Domain: Medical · Regulation