On the urgent need to revise the Medical Devices Regulation
B-10-2024-0128
on behalf of the ECR Group · Rapporteur: Ruggero Razza, Pietro Fiocchi, Michele Picaro, Laurence Trochu, Aurelijus Veryga
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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.¶¶ It asks for temporary certification extensions, support for SMEs, strengthened notified bodies, fast-track approvals in health crises, inclusion of e-health apps, supply chain resilience, transparency, binding timelines, correct product classification, tailored EUDAMED transparency, a shortage report, and harmonised implementation.¶¶¶
Key points
- Expresses deep concern about negative effects of MDR implementation delays on innovation, SME competitiveness, certification companies, and patient access to medical devices.¶
- Calls on the Commission to urgently revise the MDR to simplify approval procedures, particularly for low-risk devices and technological innovations, reduce administrative burden, and lessen unmet medical needs.¶
- Invites the Commission to introduce a temporary mechanism to extend existing certifications pending full implementation of the new framework, and to streamline certification to prevent shortages.¶
- Stresses the need to balance rigorous safety requirements with rapid approval processes, especially for innovative devices with significant benefits.¶
- Calls for specific support measures for SMEs, including technical and financial assistance, and for measures to strengthen notified bodies' capacity to handle innovation.¶¶
- Suggests considering a fast-track procedure for vital medical devices during health crises, focusing on shortages caused by the transition to MDR and IVDR.¶
- Stresses the need to protect health data from e-health applications by including them in the revised MDR's scope with appropriate provisions.¶
- Calls on the Commission and Member States to strengthen supply chain resilience through diversified production and better coordination to avoid shortages.¶
- Stresses the importance of transparency in certification and invites the Commission to publish regular progress reports on MDR implementation.¶
- Stresses the need for predictable timelines and costs, and calls for binding legislative measures requiring notified bodies and manufacturers to respect mutual obligations.¶
- Emphasises the importance of promoting correct classification of products to embrace innovation and avoid obstacles to innovative therapies from the medical device sector.¶
- Points out that EUDAMED transparency may be exploited to interfere with the EU and Member States, so information should be tailored to the audience; calls for a detailed report on shortages and increased collaboration.¶¶¶
Who is affected
- Medical device manufacturers, particularly SMEs, will face simplified procedures and support measures.¶¶
- Notified bodies will need to strengthen capacity and adhere to binding timelines.¶¶
- Patients and healthcare systems will benefit from reduced shortages and faster access to innovative devices.¶¶
- E-health application developers will be subject to the revised MDR's scope.¶
Legal basis: Article 168 and Article 114 of the Treaty on the Functioning of the European Union¶¶