IMDRF Publishes Report on Implementation of IMDRF Guidance

By Beth Pugh and Evangeline Loh

Background on IMDRF Report 

The International Medical Device Regulators Forum (IMDRF) published a report on Sept. 1, 2026 (IMDRF/MC/N84 FINAL:2026), on the implementation status of guidance among IMDRF members (Australia, Brazil, Canada, China, the EU, Japan, Russia, Singapore, South Korea, Switzerland, U.K., U.S.) and Official Observers (Argentina, Saudi Arabia). 

The report is organized by the IMDRF Working Group (WG) and each document is delineated as well as the level of implementation: implemented, partly implemented and not implemented. In addition, NA is used as a footnote if the guidance is not relevant. The report doesn’t discuss MDSAP documents.

Status of documents

All the guidance documents were implemented in at least three IMDRF members, except for the 2023 guidance on Personalized Medical Devices — Production Verification and Validation, which was only implemented in Singapore.

The most well-implemented guidance appears to be from the Adverse Event Terminology (AET) WG, and the document on IMDRF Terminologies for Categorized Adverse Event Report (AER) Terms, Terminology Structure and Codes, which had been fully implemented by all members except China and Russia.

IMDRF AE codes

The IMDRF AE codes are used by nearly all IMDRF members and play a pivotal role in helping manufacturers identify trends and safety signals. For example, the new ANVISA e-Notivisa system for initial reports submitted by hospitals and users also requires the inclusion of an IMDRF AE code.

Emergo by UL recommends that manufacturers use IMDRF AE codes in risk management files and map complaint codes to IMDRF AE codes to detect potential product problems as quickly as possible. 

Concluding remarks

The results of the IMDRF Report reflect ongoing implementation of IMDRF guidance among members and Official Observers.

In addition to the concept of regulatory reliance and the work of the Regulated Products Submission WG and other WGs, tremendous progress has been made in the adoption and use of the IMDRF AE codes.

IMDRF continues to make progress in global harmonization and regulatory reliance activities.