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
16 December 2025 · European Parliament and Council of the EU
Official records, titles and legal texts are shown in their original English version.
1. Official source details
- Official title
- 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
- Issuing authority
- European Parliament and Council of the EU
- Document type
- Proposal for a regulation
- Publication date
- 16 December 2025
- Identifier
- CELEX 52025PC1023
- Official source
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC1023 (opens official source in a new tab)
- Collected via
- EUR-Lex / EU Publications Office
2. Executive summary
Official metadata: Proposal for a regulation dated 2025-12-16. In the official EU Publications Office metadata this document proposes to amend the AI Act.
Not yet analysed.
3. Legal status and effective date
Proposal — not adopted law (Legislative process)
Effective / application date: Not stated in the source metadata.
4. Relevant articles
No AI Act article is explicitly referenced in the source metadata.
5. Potentially affected stakeholders
Not identified in the source metadata.
6. Practical implications
Not yet analysed. The legal status above is taken from the official document type.
7. Suggested control considerations
Not yet analysed.
8. References and official links
- EUR-Lex / EU Publications Office (opens official source in a new tab) (first retrieved 13 November 2026, 11:35 UTC)
- Regulation (EU) 2024/1689 (Artificial Intelligence Act) on EUR-Lex (opens official source in a new tab)
9. Last source verification
13 November 2026, 12:18 UTC · first retrieved 13 November 2026, 11:35 UTC
This monitor is regulatory intelligence, not legal advice. Official metadata, titles and dates come directly from EU sources; legal status labels follow the official document type. Only texts published in the Official Journal of the European Union are legally authentic. Interpretations marked “OrbletiQ AI-assisted analysis” are generated with AI and published only after OrbletiQ review.