On the urgent need to revise the Medical Devices Regulation
B-10-2024-0121
on behalf of The Left Group · Rapporteur: Catarina Martins
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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.¶¶¶ It regrets possible shortages of medical devices, especially in paediatric care and orphan devices, and stresses the need for full implementation of EUDAMED and for any future revision to be patient-centred.¶¶¶
Key points
- Expresses continued support for strong protection of patient health and safety through correct implementation of the MDR and IVDR, underlining that patient safety must never be compromised.¶
- Regrets possible shortages of medical devices and risks thereof, notably in paediatric care and orphan devices, resulting mainly from suboptimal implementation of the legal framework.¶
- Welcomes the Commission's ongoing non-legislative actions to support the transition, including advice, training, and support for innovative and orphan devices.¶
- Stresses that the ongoing evaluation of the MDR and IVDR should be concluded and its results fully taken into account in any future revision, accompanied by a full impact assessment.¶
- Underlines that citizens, patients, governments, civil society, and manufacturers have a right to information on notified bodies' certification processes, including timelines and fees.¶
- Regrets that notified bodies seem to have been misusing their critical position in the value chain, endangering patient safety and treatment options.¶
- Expects all manufacturers to meet MDR and IVDR requirements without further delay, and all notified bodies to ensure safe and reliable devices get timely and affordable market access.¶¶
- Calls on the Commission to step up efforts for common and transparent working methods among notified bodies, and to explore harmonisation via implementing or delegated acts.¶
- Calls on the Commission to investigate ways to increase transparency of the entire certification process so that the public, civil society, academia, and governments can scrutinise the work.¶
- Calls for full implementation of EUDAMED in accordance with the agreed timeline.¶
- Underlines that any future legislative proposal on medical devices should be patient-centred and put patient safety first.¶
Who is affected
- Manufacturers of medical devices: expected to meet MDR and IVDR requirements without delay.¶
- Notified bodies: expected to ensure timely and affordable market access for safe devices and to use transparent methods.¶¶
- Patients and citizens: have a right to information on certification processes and benefit from increased transparency.¶¶
Legal basis: Article 168 of the Treaty on the Functioning of the European Union¶