Urgent need to revise the MDR

The EU Commission is urged to propose solutions by no later than the end of Q1, 2025.

The revisions will seek to address the many challenges and bottlenecks associated with placing and maintaining medical devices within the EU market, particularly from the perspective of manufacturers and notified bodies (NB) in ensuring timely access to safe medical device products throughout the EU.

This will likely include a systematic revision to all relevant articles of the MDR 2017/745 and IVDR  2017/746 and subsequent impact assessment, to be proposed no later than Q1 2025. Any new rules will be linked to appropriate transition periods.

Some of the highlights from the full text TA-10-2024-0028_EN

• Stressing that access to medical device products should not depend on where in the EU a patient is located.
• Encouraging NBs to ensure sufficient resources exist to meet demands in a timely manner
• Creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by NBs to avoid uncertainty for manufacturers.
• Reducing administrative overhead without a reduction in patient safety and provide support in particular to small and medium business enterprises (SMEs).
• Eliminating unnecessary recertification requirements for certain updates via harmonized procedures.
• Exploring fast-tracks and prioritization pathways for approval of areas in unmet medical need or public health emergencies
• Including e-health devices within the scope of the MDR to protect collected health data

Urgent full implementation of the EUDAMED database to allow better access of information and transparency for the public and healthcare professionals, with a focus on monitoring of device availability such that actions can be taken to keep them available in the EU market (particularly for ‘last of type’ device examples).