Urgent need to revise the medical devices regulation
TA-10-2024-0028 · P10_TA(2024)0028 · PE764.132
- Adopted in plenary on · Adopted 0–0–0 · See the decision →
- Full procedure 2024/2849
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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.¶ It demands measures to prevent device shortages, ensure equal access across the EU, streamline certification, increase transparency of notified bodies, and support small manufacturers and orphan and paediatric devices.¶¶¶ It calls for fast-track approval for innovative technologies, inclusion of e-health applications in the revised rules, a definition of 'orphan device', and full implementation of the European Database on Medical Devices.¶¶¶
Key points
- Calls on the Commission to propose delegated and implementing acts by the end of Q1 2025 and a systematic revision of all relevant articles of the MDR and IVDR, with an impact assessment.¶
- Urges full use of legislative and non-legislative tools to resolve divergent interpretations, streamline processes, improve transparency, and reduce administrative burden, especially for SMEs, without compromising patient safety.¶
- Deplores the risk of shortages and unequal access to medical devices and in vitro diagnostics across the EU; stresses that access should not depend on location.¶
- Encourages notified bodies to have sufficient resources; calls on the Commission and Member States to support them to achieve optimal capacity.¶
- Advocates transparent and binding timelines, including clock stops, for conformity assessment by notified bodies to create predictability for manufacturers.¶
- Calls for transparency in notified bodies' fees and fee structures to allow comparison and informed choices.¶
- Stresses the need to eliminate unnecessary re-certification, harmonise provisions, ensure correct classification, and foster cooperation among authorities.¶
- Calls on the Commission to consider fast-track and prioritisation pathways for innovative technologies in unmet medical need and health emergencies.¶
- Stresses the need to protect health data from e-health applications by including them in the revised MDR with appropriate provisions.¶
- Highlights the need for a clear definition of 'orphan device' and a system to prevent misuse through artificial 'orphanisation'.¶
- Calls for adapted rules for orphan and paediatric devices, more efficient conformity assessment for small markets, and support for SMEs including model documents and guidance.¶¶
- Calls for continuous monitoring of device availability, especially last remaining devices, and urgent full implementation of EUDAMED.¶
Who is affected
- Manufacturers of medical devices and in vitro diagnostics, particularly small and medium-sized enterprises, will face revised rules and potential changes in certification processes.¶¶¶
- Notified bodies will need to ensure sufficient resources and may face new transparency requirements on fees and timelines.¶¶¶
- Patients and healthcare professionals across the EU could benefit from improved access to devices and information, but may face transition periods during rule changes.¶¶¶
- Developers of e-health applications will see their products brought under the medical devices regulation.¶
Figures and deadlines
- Q1 2025: deadline for the Commission to propose delegated and implementing acts.¶
Legal basis: Article 168 of the Treaty on the Functioning of the European Union¶