At a glance
- Short name
- EU MDR
- Issuing / stewarding body
- European Commission
- Jurisdiction
- EU
- Also known as / related labels
- ISO 13485 · MDCG Guidance · MDR Annex VII (requirements for notified bodies) · Regulation (EU) 2023/607 (transition extension)
What this entry covers
Regulation (EU) 2017/745 on medical devices (MDR) has applied since 26 May 2021, replacing the earlier medical device directives. It covers device classification, conformity assessment by notified bodies, clinical evaluation, post-market surveillance and vigilance for manufacturers placing devices on the EU market. Guidance on applying it is published as MDCG documents endorsed by the Medical Device Coordination Group.
MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid, not legal advice, and is not a substitute for the official text.
Official documentation
- Primary official source: https://health.ec.europa.eu/medical-devices-new-regulations/overview_en
- Legal text (EUR-Lex): https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
- MDCG endorsed documents and other guidance: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
Recent changes
- 2025-12-16: The European Commission proposed a targeted revision of the MDR and IVDR, COM(2025) 1023. It is a proposal only and becomes binding only if adopted by the European Parliament and Council. European Commission
- 2023-03-15: Regulation (EU) 2023/607 extended the MDR transition period for legacy devices, subject to conditions, to 31 December 2027 for class III and most implantable class IIb devices and to 31 December 2028 for other class IIb, class IIa and certain class I devices, and removed the sell-off deadline. European Commission, EUR-Lex
How to use this index entry
- Open the official link above (or the agency home if the deep link drifts).
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Index only — not legal advice.
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