Regulatory pathway · all topics

EU Medical Device Regulation (MDR)

Regulation (EU) 2017/745 (MDR) replaced the Medical Device Directive on 26 May 2021. Stricter clinical evidence requirements, mandatory UDI, EUDAMED registration, more rigorous post-market surveillance. Class IIa/IIb/III devices require notified body conformity assessment. Transitional provisions extended for legacy devices through May 2027 (Class III) or Dec 2028 (Class IIb implants). Person Responsible for Regulatory Compliance (PRRC) is mandatory.

Source

Regulation (EU) 2017/745, Medical Device Regulation

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745

How MedTek OS handles this

Compass drafts the eu medical device regulation (mdr) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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