The International Medical Device Regulators Forum (IMDRF) has released its updated Standard Operating Procedures (IMDRF/MC/N2FINAL:2025, Edition 13 Version 2). This critical document lays out the framework for how international medical device regulatory convergence is managed across member and observer jurisdictions.
Key highlights of the document:
Clear roles and application pathways for Management Committee Members, Official Observers, Affiliate Members, and Regional Harmonization Initiative (RHI).
7-stage process for developing technical guidance, with public consultation at the Proposed Document stage.
Structured processes for document revision, translation, and training dissemination.
Clarified rules for membership suspension, termination, and withdrawal.
Greater focus on inclusivity, contribution, and accountability among IMDRF participants.
This update reinforces IMDRF’s mission to strategically accelerate medical device regulatory convergence and support safe, effective technologies globally through structured cooperation and document governance.
Link to the document: https://lnkd.in/ewJnutZR