The European Commission has just confirmed that, due to the current health emergency, in early April it will present a legislative proposal to pospone the MDR application date by 1 year (May 26, 2021)
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- EU CTR Q&A Version 7.3 is Out
- New WHO guide on Artificial intelligence-related health research
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- MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- New ISO Guidance for AI-Powered Medical Devices: ISO/TS 24971-2:2026 Published!
- Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
- MDCG Position Paper: UDI assignment between manufacturers and distributors