The European Parliament has published the adopted text of the resolution for the “Urgent need to revise the medical devices regulation

The resolution aims to ensure that regulations adapt to evolving medical needs and innovation while maintaining patient safety.

The resolution stresses the need for:
• Reduce administrative burdens without compromising patient safety
• Support measures for SMEs
• To eliminate the unnecessary re-certification of products
• Calls for transparency in notified bodies’ fees and fee structure
• Fast-track approval for innovative technologies
• Support for small markets such as orphan and paediatric devices
• The inclusion of e-health applications within the MDR
• An urgent full implementation of EUDAMED

The Commission is urged to propose solutions by Q1 2025.