The new edition of the IMDRF Operating Procedures (Edition 13, 2025) clarifies the mechanisms for joining, developing and managing technical and regulatory documents in the medical devices sector. This document reinforces IMDRF's role in international harmonization, with a direct impact on the predictability of the rules applicable to manufacturers. The participation of regulatory authorities and industry stakeholders in these processes makes it possible to align technical requirements with global principles of compliance, safety and performance.

The coordinated assessment pilot project for clinical investigations and performance studies aims to harmonize the regulatory process for medical devices in the European Union. Based on Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), this pilot promotes transparency and efficiency, reducing the administrative burden and speeding up regulatory approval.