Current thinking on SaMD/AIaMD regulation
Global initiatives
The International Medical Devices Regulatory Forum (IMDRF) is a voluntary organisation that has representation from leading national regulatory authorities. It was the body that first coined the term 'software as a medical device' and the definition given on the Introduction page is due to the IMDRF. Its suggested Framework for risk categorisation of SaMD has provided the basis for much of the regulatory activity at national and European level.
European Union
The MDCG has produced various guidance documents on SaMD. They are listed (amongst numerous other documents) here. MDCG 2019-11 (on qualification and classification on MDSW) and MDCG 2019-16 (on cybersecurity) are the most relevant.
The EU AI Act (AIA) will have a significant effect on AIaMD manufacturers as most of the AI-specific requirements will come from the AIA. The Act defines most medical devices as high-risk AI systems, so manufacturers of AIaMD products will need to pay close attention to the AIA as well as the EU MDR. The MDCG has produced some initial guidance on the interplay between the AIA and the MDR (click here to read) but it leaves quite a few questions unanswered. There are numerous issues associated with the AIA. Some EU member states still calling for a "stop the clock" on full implementation plans and enforcement, but these have so far been rejected by the EC.
Meanwhile the EC has embarked on a broad programme of legislative simplification (known as the Digital Package or Digital Omnibus), which aims to cut the administrative burden on businesses. Immediate target areas include data legislation (rules on cookies etc), cybersecurity incident reporting, and "targeted adjustments to the Artificial Intelligence Act to ensure the optimal application of the rules". There was a call for evidence on the simplification package proposals in October 2025.
United States
The FDA launched its novel Software Precertification Pilot Program in 2017, based on the idea of trusted manufacturers. Unfortunately, it was withdrawn in 2022 after running into legal issues, but the Agency's Digital Health Center of Excellence (DHCoE) continues to refine concepts from the pilot, including regulatory science partnerships with organisations such as the Medical Device Innovation Consortium (MDIC) in order to encourage and promote consensus-based innovation.
Regarding AI, the FDA's concept of the Predetermined Change Control Plan (PCCP) is one of the cornerstones of its approach to AIaMD regulation; an idea that is also used - with some slight change of meaning - in the EU AI Act.
United Kingdom
We have already mentioned the MHRA "roadmap" for SaMD and AIaMD on the Radiology page. Things will become clearer when the remaining parts of the new UK Medical Device Regulation are published in 2026. For now, placing medical devices on the GB market is still governed by UK MDR 2002!* Note that special post-Brexit arrangements were established for Northern Ireland, which remains subject to the EU MDR.
*(with various periodic amendments).