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Adottati on 29/04/2026 - Bureau decision date: 02/12/2025ReferenzaINT/1116-EESC-2025-04298-00-00-AC-TRAOpinion TypeMandatoryCommission ReferencesOfficial JournalPlenary session number605-
European Economic
and Social Committee
Proposal for a Regulation - Targeted revision of the EU rules for medical devices and in vitro diagnostics - Timeline
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Procedure 2025/0404/COD
COM (2025) 1023: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
OngoingType: Ordinary legislative procedure (COD)- Legal basis:
Commission: 12010E294-A294 ; 12010E168-A168P4 ; 12010E114-A114- EuroVoc thesaurus:
- harmonisation of standards; medical device; public health
- Directory code:
- 15.20.30.00 Environment, consumers and health protection / Consumers / Protection of health and safety
- Type of the competence conferred on the EU:
- Shared competence
For a detailed overview of the procedure, please visit the EU Law Tracker.
EU Law TrackerSteps of procedure 2025/0404/COD
/Opinions
29/04/2026- Responsible body:
- Section for the Single Market, Production and Consumption
- Rapporteur:
- Danko RELIĆ
- Procedure:
- Ordinary legislative procedure (COD)
- Plenary session:
- 605
- Plenary date:
- 29/04/2026 - 30/04/2026
- Documents:
- EESC 2025-04298
- CELEX number of the main document:
- 52025AE4298
Proposal
17/12/2025- Leading person:
- Olivér VÁRHELYI
- Leading service:
- Directorate-General for Health and Food Safety
- Decision mode:
- Oral procedure
- Addressee for formal act:
- European Parliament ; Council of the European Union ; National parliaments
- Addressee for mandatory consultation:
- European Economic and Social Committee ; European Committee of the Regions
- Legal basis:
- 12010E294-A294 ; 12010E168-A168P4 ; 12010E114-A114
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- COM/2025/1023/FINAL
SWD/2025/1050/FINAL
SWD/2025/1051/FINAL
SWD/2025/1052/FINAL - CELEX number of the main document:
- 52025AE4298 ; 52025SC1050 ; 52025SC1051 ; 52025SC1052 ; 52025PC1023