What EU MDR Annex IX - Conformity Assessment Procedures for High-Risk Devices requires
Detailed procedures for Class IIb and III devices including QMS audits, technical documentation review, and clinical evaluation consultation. 2026 amendments strengthen scrutiny for AI/ML components under Rule 11.
Pillar: Medical & Healthcare · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
SHA-256 integrity: 0520e608f60e725be7c24822a4b2eae8f7925c1c297b3e023f8cb14700e572a8
Primary Citations — 5 traced to source
- Regulation (EU) 2017/745 (MDR) Annex IX Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
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