IMDRF Updates Operating Procedures: What Manufacturers Should Know
The International Medical Device Regulators Forum (IMDRF) has published the updated version of its Standard Operating Procedures document (IMDRF/MC/N2FINAL:2025, Issue 13), establishing formal guidelines for the operation of the organization and the development of technical and regulatory documents in the medical device sector.
This guiding document reinforces IMDRF's strategic role in international regulatory convergence, establishing clear rules for the organizational structure, membership and participation criteria, and the development, revision and implementation of technical and information documents.
What changes with this edition?
The new version provides greater clarity and systematization:
Membership criteria for members, official observers, affiliates and regional harmonization initiatives (RHIs);
Formal procedures for suspending or terminating members, with defined deadlines and transparency rules;
Rules for creating new working groups and subcommittees, including composition, functions and selection criteria;
Life cycle of technical documents, from initial proposal (NWIP) to publication and implementation;
Document classification and coding, promoting consistency and traceability;
Mechanisms for interaction with stakeholders, including industry, through public consultations, invited observers and participation in open working groups.
For manufacturers, why is it important?
Although this document is aimed at regulators, medical device manufacturers should be aware for several reasons:
Greater predictability and transparency in the processes of drawing up documents that can directly impact technical and regulatory requirements;
Potential for indirect participation in open working groups and public contributions;
Alignment with the IMDRF principles can facilitate access to multiple markets, thanks to the harmonization of requirements;
Better understanding of the roles and influences of national and regional authorities in developing guidelines that shape the sector.
Smart MDR closely follows regulatory developments promoted by international bodies such as IMDRF and supports manufacturers in aligning with global regulatory best practices.
Contact us to find out how these changes could impact your compliance and market access strategy.
