Resolution on a topical subject (RSP): Parliament states its view. It is not binding. Resolution on a topical subject First reading
Urgent need to revise the medical devices regulation
A resolution tabled by political groups, usually on an urgent matter or in reaction to a statement by the Commission or Council. Not binding.
Where it stands: Parliament adopted the text on 23 October 2024. This is its final position on the matter.
- ✓ Tabled for plenary
- ✓ Plenary vote Adopted 23 October 2024
- ✓ Parliament’s position Final
How a file moves through Parliament
A file is referred to one lead committee (others may give an opinion). Its rapporteur writes a draft report, committee members table amendments, and the committee votes to adopt the report. The report is then tabled for all MEPs; political groups can table further amendments, which are voted on before the final vote in plenary. The adopted resolution is Parliament’s final position; it is not itself law.
The text, version by version
Adopted by Parliament · latest Adopted text TA10-0028/2024 23 October 2024 ✦ Parliament calls on the Commission to propose delegated and implementing acts by the end of Q1 2025 and a systematic revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, with an impact assessment, to address implementation challenges.⇄ what changed Tabled for plenary Joint motion RC-B10-0123/2024 21 October 2024 ⇄ what changed Tabled for plenary Motion for a resolution B10-0125/2024 16 October 2024 ✦ This resolution calls on the Commission to propose a systematic revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation within the first hundred days of the new mandate.← Tabled for plenary Motion for a resolution B10-0124/2024 16 October 2024 ✦ This resolution addresses the urgent need to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), citing shortages, access inequalities, and administrative burdens.← Tabled for plenary Motion for a resolution B10-0121/2024 16 October 2024 ✦ This resolution addresses the urgent need to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), expressing support for strict patient safety and calling for improved implementation and transparency.← Tabled for plenary Motion for a resolution B10-0126/2024 16 October 2024 ✦ Parliament stresses support for swift implementation of the Medical Devices Regulation and In Vitro Medical Devices Regulation, and urges action to prevent device shortages, improve transparency, and strengthen post-market surveillance.← Tabled for plenary Motion for a resolution B10-0122/2024 16 October 2024 ✦ The resolution calls for urgent revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, citing excessive bureaucracy, certification backlogs, and product shortages.← Tabled for plenary Motion for a resolution B10-0127/2024 16 October 2024 ✦ Parliament calls on the Commission to propose a revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation to address implementation challenges.← Tabled for plenary Motion for a resolution B10-0123/2024 16 October 2024 ✦ This resolution addresses the urgent need to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). It calls for action to improve implementation, harmonise procedures, and ensure patient safety.← Tabled for plenary Motion for a resolution B10-0128/2024 16 October 2024 ✦ Parliament expresses concern about delays in implementing the Medical Devices Regulation (MDR) and calls on the Commission to urgently revise it to simplify approval procedures, reduce administrative burden, and address unmet medical needs.
Latest Tabled for plenary → Adopted by Parliament: The new version adds two recitals and one paragraph on substance-based medical devices and e-health applications, calling for their inclusion in the revised regulation to protect health data and foster innovation. see the changes →
Newest version first. Open a version to read it in full. “What changed” shows the differences paragraph by paragraph; ✦ lines are AI-written from the texts themselves.
Timeline
- Plenary stage
- 23 October 2024 Plenary voteSitting of 23 October 2024 📄 Motion for a resolution B10-0121/2024📄 Motion for a resolution B10-0122/2024📄 Motion for a resolution B10-0123/2024📄 Motion for a resolution B10-0124/2024📄 Motion for a resolution B10-0125/2024📄 Motion for a resolution B10-0126/2024📄 Motion for a resolution B10-0127/2024📄 Motion for a resolution B10-0128/2024📄 Adopted text TA10-0028/2024Adopted Adopted
Show all 17 ballots in voting order
1. Separate vote on paragraph 1RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded2. Separate vote on paragraph 1RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded3. Separate vote on paragraph 1Rejectedelectronic vote (totals only) — no individual positions recordedAdoptedAdopted6. Vote on text inserted after paragraph 8Adoptedelectronic vote (totals only) — no individual positions recorded7. Vote on text inserted after recital NAdoptedelectronic vote (totals only) — no individual positions recorded8. Vote on text inserted after recital NAdoptedelectronic vote (totals only) — no individual positions recorded9. Final vote — text as a whole Motion for a resolution (as a whole)AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded10. Alternative motion for a resolution B10-0121/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded11. Alternative motion for a resolution B10-0122/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded12. Alternative motion for a resolution B10-0123/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded13. Alternative motion for a resolution B10-0124/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded14. Alternative motion for a resolution B10-0125/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded15. Alternative motion for a resolution B10-0126/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded16. Alternative motion for a resolution B10-0127/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded17. Alternative motion for a resolution B10-0128/2024Not put to a vote, because an earlier vote already settled the matter.A vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded - 9 October 2024 Debated in plenary
MEPs debated the text in the chamber ahead of the vote.