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 5 May 2017
- In force
- In force since 25 May 2017 · CELEX 32017R0745
- Procedure
- Regulation · Ordinary legislative procedure
- Last activity
- 25 May 2017
Where it stands
Latest: Delegated act published: Expansion of the list of well-established technologies, 29 Jun 2026.
- 19 Mar 2026
- Scrutiny finished: Expansion of the list of well-established technologies
- 29 Jun 2026
- Delegated act published: Expansion of the list of well-established technologies
Amendments
Tabled on 29 Mar 2017. The texts are in the amendment documents below.
By article
- –2
Delegated and implementing acts beneath it
By status: 17 published, 1 cancelled.
Titles link to EUR-Lex where the act has been published.
Documents
Newest first. Each opens at its source.
- Report · A7-0324/2013Parliament
- Report · A8-0068/2017Parliament
- Proposal · COM(2017)0129Commission
- Proposal · COM(2024)0560Commission
- Text adopted · Corrigendum to final act 32017R0745R(01)Commission
- Text adopted · Corrigendum to final act 32017R0745R(02)Commission
- OJ C 358 07.12.2013, p. 0010Commission
- Text adopted · OJ L 117 03.05.2019, p. 0009Commission
- Text adopted · OJ L 117 05.05.2017, p. 0001Commission
- Text adopted · OJ L 334 27.12.2019, p. 0165Commission
- Committee opinion · PE506.249Parliament
- Report · PE507.972Parliament
- Committee opinion · PE507.987Parliament
- Amendments · PE510.741Parliament
- Amendments · PE510.765Parliament
ShowHide the other 8 documents
- Amendments · PE510.766Parliament
- Amendments · PE510.767Parliament
- Report · PE601.098Parliament
- Text adopted · Regulation 2017/0745Commission
- Text adopted · SP(2014)471Parliament
- Text adopted · T7-0266/2014Parliament
- Text adopted · T7-0428/2013Parliament
- Text adopted · T8-0107/2017Parliament
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: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.
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