New medical devices Post-market Surveillance regulations in force
From today, new legal requirements for monitoring the safety of medical devices take effect, as part of our broader transformation of the UK’s medical device regulatory framework.
The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. Today’s reform applies to all UKCA- and CE-marked devices placed on the GB market from today (16 June 2025). It requires device manufacturers to actively track the safety and performance of their products. This will help identify potential safety issues earlier and strengthen protection for patients and the public through faster responses to incidents and emerging risks.
Following stakeholder feedback, guidance has been updated to improve clarity and provide further support for manufacturers to help understand the changing obligations.
