Medical devices: post-market surveillance requirements (MHRA, last updated 16 June 2025)

Summary

Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.

Content

New regulations have come into effect in the UK which place a greater emphasis on medical device manufacturers to monitor the safety and performance of their products.

The new Post-Market Surveillance (PMS) regulations came into effect from Monday (16 June) requiring device manufacturers to actively track the safety and performance of products already in use. The reforms, which are a part of a wider effort by the Medicines and Healthcare products Regulatory Agency (MHRA) to overhaul the UK’s medical device regulatory framework, are intended to identify potential safety issues earlier and to strengthen protection for patients and the public through faster responses to incidents and emerging risks.

The reform applies to all UKCA- and CE-marked devices placed on the market in Great Britain after 16 June. This includes in vitro diagnostic devices, active implantable medical devices as well as other technologies used in a clinical setting and within the home.