Medical Devices Regulation
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- Stage
- In force, reached 19 Mar 2026
- In force
- In force since 25 May 2017 · CELEX 32017R0745
- Procedure
- Regulation
- Last activity
- 28 Jun 2026
Where it stands
Latest: Delegated act published: Expansion of the list of well-established technologies, 28 Jun 2026.
- 19 Mar 2026
- Delegated act published: Expansion of the list of well-established technologies
- Scrutiny finished: Expansion of the list of well-established technologies
- 28 Jun 2026
- Delegated act published: Expansion of the list of well-established technologies
Delegated and implementing acts beneath it
By status: 15 published, 1 cancelled.
Titles link to EUR-Lex where the act has been published.
Summary
GeneratedThe EU Medical Devices Regulation (2017/745) governs placing on the market, making available, and putting into service of medical devices for human use in the EU, replacing the previous directives. It applies from 26 May 2021, with transitional provisions allowing certain legacy devices to remain on the market until 31 December 2028.
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Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
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