[2025-09-01] On September 1st, 2025, the IMDRF (International Medical Device Regulators Forum) published its annual report summarizing the degree of document implementation by the various participating regulatory authorities (members and official observers).
This 14-page document, entitled“IMDRF/MC/N84 FINAL:2025 (Edition 2) – IMDRF Document Implementation Report”, consists of a series of tables showing the level of implementation of each IMDRF document by country.
3 levels of implementation are possible:
- “Implemented” in full;
- “Partially implemented” , when the document has not been fully considered, or the range of medical devices (MD) covered is reduced;
- “Not implemented“, sometimes with an “NA” when the document is not applicable to the country or region concerned.
Focus on MD software
If we focus on the subject of software medical devices (MD), in the broadest sense, the findings are as follows:
- Concerning documents related to DM software (Software as a Medical Device (SaMD) working group):
- The USA have caught up, having now fully implemented all the guides. Indeed, at the time of the previous report, the USA had only partially implemented some of them.
- The UK, on the other hand, is still lagging behind, with all the guides in this section partially implemented.
- The most recent guide (IMDRF/SaMD WG/N81 FINAL:2025 – Characterization Considerations for Medical Device Software and Software-Specific Risk) has already been fully implemented by Canada, the European Union, Japan, South Korea, Singapore and the USA.
- With regard to cybersecurity (“Medical Device Cybersecurity (Cyber)” working group):
- The “IMDRF/CYBER WG/N70 FINAL:2023 – “Principles and Practices for the Cybersecurity” guide has already been fully implemented by the European Union, the USA, South Korea and Switzerland.
- the “IMDRF/CYBER WG/N73 FINAL:2023 – Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity” guide has only been fully implemented by Canada, the USA and South Korea.
- the UK has not implemented any of the guides.
- Finally, for the “Artificial Intelligence (AI)” working group:
- The majority of IMDRF members, with the exception of Japan, Singapore, Brazil and Australia, apply the guide “IMDRF/AIMD WG/N67 FINAL:2022 – Machine Learning-enabled Medical Devices: Key Terms and Definitions”. This guide is indicated as not applicable for the UK.
- The vast majority of IMDRF members (European Union, Japan, South Korea, Switzerland, United Kingdom and United States) have fully implemented the “IMDRF/AIML WG/N88 FINAL:2025 – Good Machine Learning Practice for Medical Device Development: Guiding Principles” guide.
Conclusion
IMDRF documents cover many other topics in addition to software MD. This summary details the status of their implementation.
This table shows the efforts still required for full harmonization towards a common regulatory framework within the organization. The UK seems to be stalling on many issues (with the exception of Artificial Intelligence). It is also interesting to note the very rapid adoption of the IMDRF 2025 guide on Artificial Intelligence.
Article written by Karim Chelly, member of the DMEXPERTS network.