What Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC requires
The EU Medical Devices Regulation (MDR) 2017/745 establishes a comprehensive framework for the safety and performance of medical devices in the EU, requiring manufacturers to classify devices (Annex VIII), generate robust clinical…
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Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
SHA-256 integrity: 0c4c1cc775a606d54e83e4479cd227934be8f2f21b495a12ff70f6bac99c9221
Primary Citations — 5 traced to source
- Regulation (EU) 2017/745, Article 51 - Rules for classification of devices
- Regulation (EU) 2017/745, Annex VIII - Classification rules
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