FDA expands its TAP Pilot with more devices and new areas. Key updates and what medical device manufacturers need to know.

Team-NB warns that proposed MDR and IVDR revisions could reduce regulatory scrutiny and create unintended consequences for EU manufacturers, despite improvements in digitalisation and innovation pathways.

MHRA updates guidance on medical device regulation in Northern Ireland. Key impacts for manufacturers under EU MDR and IVDR.

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.