What EU IVDR 2017/746 (Diagnostics) requires
EU Regulation 2017/746 (In-Vitro Diagnostic Medical Device Regulation - IVDR) is the primary framework for diagnostic devices in the European Union. It replaces the previous 98/79/EC directive and dramatically increases the oversight of IVDs, requiring nearly 80% of devices to undergo notified body audit (vs. 20% previously).
Pillar: Medical & Healthcare · Authority: European Parliament and the Council of the European Union · Version: 1.1.0 · Last updated:
Primary source: https://eur-lex.europa.eu/eli/reg/2017/746/oj
SHA-256 integrity: 4341d19c58cfdad0f1b10f3e52c1fbb41b6fd452709d0a01d69f84d376bc8649
Primary Citations — 7 traced to source
- EU Regulation 2017/746, Article 15: Person responsible for regulatory compliance (PRRC)
- EU Regulation 2017/746, Article 47 & Annex VIII: Classification rules for in vitro diagnostic medical devices
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