U.K. news..

The process of producing new UK medical device regulations to replace the UK MDR 2002 has been a long drawn out affair, complicated by the UK's withdrawal from the EU ('Brexit) in January 2020 and the COVID-19 epidemic.

Fast forward to the recent past, and the MHRA conducted a public consultation on proposed new regulations in late 2021. At that point, the revised regulations were planned for June 2023. In December 2024, the UK issued a Statutory Instrument (S.I) on post market surveillance of medical devices, which came into force in July 2025.

The remainder of the new UK medical device regulations (3 more S.I's) are expected by early 2026. Until then, Great Britain continues to be governed by the UK's 2002 Medical Device Regulations, which are based on the old EU Medical Device Directives. Note that Northern Ireland is subject to EU MDR17 under the special arrangements made following Brexit. Click here for more information.

U.S. News

The FDA is pressing ahead with its planned programme of changes (including the new QMSR regulation, which comes into force in February 2026) but there are concerns that recent job losses at the Agency will lead to longer delays in getting devices (especially AI-enabled devices) approved for market. At present, these are just concerns, so the situation is being monitored.

For more information on how the various regulatory agencies are planning to deal with medical device software in general, and AI-enabled medical device software in particular, click here.

This page was last updated: 22 Sept 2025