Where the law stands, Dossier 2024/2849(RSP)
Urgent need to revise the medical devices regulation
Resolution on a topical subject (RSP): Parliament states its view. It is not binding. · First reading
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’s position
Parliament adopted the text on 23 October 2024. This is its final position on the matter.
- Tabled for plenary(done)
- Plenary vote(done) Adopted 23 October 2024
- Parliament’s position(done) Final
Decided in plenary
23 October 2024 · decision 5
Economy & single market, Resolution
Urgent need to revise the Medical Devices Regulation
Adopted Decided by show of hands: no count recorded.
AI summary:The revision should address implementation challenges, consider stakeholders' views, and focus on timely availability of medical technologies, a more predictable system, and less administrative burden for manufacturers.
What changed
Latest Tabled for plenary → Adopted by Parliament
AI summary: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.
The text, version by version
Newest first.
Adopted by Parliament· 23 Oct 2024
AI summary: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.
Tabled for plenary· 21 Oct 2024
Tabled for plenary· 16 Oct 2024
Motion for a resolution B10-0125/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0124/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0121/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0126/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0122/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0127/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0123/2024
AI summary: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· 16 Oct 2024
Motion for a resolution B10-0128/2024
AI summary: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.
Timeline
Newest first.
Plenary stage 2 steps
23 October 2024
Plenary vote
Sitting of 23 Oct 2024 Motion for a resolution B10-0121/2024Motion for a resolution B10-0122/2024Motion for a resolution B10-0123/2024Motion for a resolution B10-0124/2024Motion for a resolution B10-0125/2024Motion for a resolution B10-0126/2024Motion for a resolution B10-0127/2024Motion for a resolution B10-0128/2024Adopted text TA10-0028/2024
9 October 2024
Debated in plenary
MEPs debated the text in the chamber ahead of the vote.
Official record: Legislative Observatory, 2024/2849(RSP)