EuromContact’s contribution to the targeted evaluation of the EU MDR: Proposals for a more effective and proportionate regulation

With the ongoing targeted evaluation of the MDR, EuromContact has conducted a comprehensive review of the EU Medical Devices Regulation (MDR) to assess its impact and identify areas for improvement from the point of view of manufacturers of class IIa and IIb devices.

Today EuromContact published its in-depth analysis, emphasizing the need for a more proportionate and risk-based approach. The paper presents concrete proposals to enhance regulatory clarity, reduce unnecessary complexity, and maintain high safety standards across various MDR chapters, including Identification and traceability of devices,  Classification and conformity assessment, General Safety and Performance Requirements, Clinical evaluation and investigations, Post-market surveillance and vigilance and Annex XVI products.

By prioritizing patient safety and quality while minimizing bureaucratic obstacles, these proposed measures aim to improve regulatory harmonization and efficiency across Europe.

More about this : Read EuromContact contribution to the targeted evaluation of the EU MDR