What Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices requires
The EU In Vitro Diagnostic Regulation 2017/746 requires manufacturers of in vitro diagnostic medical devices to comply with the requirements outlined in Article 17, including the conduct of performance studies and the establishment of a quality management system. This regulation applies to all manufacturers of in vitro diagnostic medical devices that are placed on the EU market.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and Council · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
SHA-256 integrity: 2c61cad120f80cdc11ac32e042ac4f549737e775aa3dbfb08fca5b80d77dba40
Primary Citations — 5 traced to source
- Regulation (EU) 2017/746, Article 17 - Device classification
- Regulation (EU) 2017/746, Article 18 - Notified body conformity assessment
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