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Revision of the Medical Devices Regulation

COMCMT1R-EP1R-C2R-EPCNCADO

Updated 22mo ago

This resolution calls for urgent revisions to the EU's rules for medical devices and in vitro diagnostic devices to address implementation challenges and ensure patient safety and access to essential technologies.

The rules affect manufacturers of medical devices, particularly small and medium-sized enterprises (SMEs), notified bodies responsible for certification, healthcare providers, and ultimately, patients across the EU who rely on these devices.

Key changes aim to streamline complex regulatory procedures, improve transparency in certification, and create faster pathways for innovative devices, while also addressing potential shortages and ensuring consistent access to devices across Member States.

The Commission is urged to propose necessary acts by the first quarter of 2025 and to conduct a systematic revision of the regulations, including impact assessments, to tackle bottlenecks and ensure a smoother transition for all stakeholders.

Documents

Urgent need to revise the medical devices regulation

position · EN · 2026-04-01

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Analysis

AI-generated·2 Apr 2026·Source document·Unverified

Medical devices and in vitro diagnostic medical devices are essential for high-quality healthcare and directly impact the health, safety, and well-being of EU patients.

What changes

The Commission is called upon to propose delegated and implementing acts to address pressing challenges and bottlenecks in the MDR and IVDR, and to propose a systematic revision of all relevant articles.
The resolution calls for the creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by notified bodies.
The resolution stresses the need to eliminate unnecessary re-certification of products and harmonize provisions related to product updates or adjustments.
The resolution calls for the introduction of adapted rules for orphan and paediatric medical devices, with more efficient conformity assessment procedures tailored to smaller markets.
The resolution calls for the urgent full implementation of EUDAMED to enhance transparency, improve access to information, and strengthen coordination between Member States.

Expected impact

The MDR and IVDR introduced more robust requirements for clinical evaluations, post-market surveillance, and vigilance reporting.
Challenges in MDR and IVDR implementation have resulted in failures to achieve certification and approval of medical devices.
Manufacturers may face unpredictable timelines for certification and market access due to a lack of harmonised procedures across notified bodies.

Limitations

The document is a resolution from the European Parliament and does not contain the full text of proposed legislative changes, only calls and recommendations.
Specific details of the proposed revisions to the MDR and IVDR, including precise wording of amendments, are not provided.
The impact assessment mentioned in Article 1 is called for but not included within this document.
The document does not provide specific data on the number of devices affected by shortages or certification delays.

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