EU MDR Compliance Updates

Updates on EU Medical Device Regulation changes, MDCG guidance, notified body requirements, and EUDAMED implementation.

9 articles | Last updated: 2026-02-23

Article	Topic	Year
Impact of EU AI Act on Medical Devices: Compliance Roadmap & Implementation Strategy	AI Act	2024
New Clinical Investigation Report Requirements: Compliance Path Without EUDAMED	Clinical	2024
EU Medical Device Regulatory Framework: Cybersecurity & Liability Innovations	Cybersecurity	2024
EUDAMED Phased Implementation Policy Update	EUDAMED	2025
Official Guide: EUDAMED UDI/Device Module Operations (v3.11.0)	EUDAMED	2025
MDCG 2019-6 Rev5: Q&A on Notified Body Requirements	MDCG	2025
PMCF Survey: Ethics Review and Informed Consent	PMCF	2025
Notified Body Certification Process: Key Path to EU MDR Compliance	NB	2024
TEAM-NB Consensus Paper on MDR Certification Process	NB	2025

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Articles link to the Chinese version. English translations are in progress for selected articles.