On 16 June 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) implemented the first major overhaul of medical device regulations in Great Britain, starting with new Post-Market Surveillance (PMS) requirements that apply to UKCA- and CE-marked devices placed on the GB market.
This marks the first active step in the UK's broader reform agenda to modernize and strengthen regulatory oversight of medical devices while aligning with real-world safety needs.
What the New PMS Regulation Requires
The regulation mandates that manufacturers proactively monitor their devices once on the market, ensuring earlier detection of safety risks and more agile response to incidents. This includes:
- Real-world safety and performance data across all device types, including IVDs, active implantable devices, and technologies used across hospitals, clinics, and at home
- Shortened timelines: serious incidents must be reported within 15 days (previously 30 days)
- Pre-submission of Field Safety Notices to MHRA before notifying users
- Faster data submissions: PMS Reports or PSURs must be sent within 3 days of MHRA request
UK approved bodies will provide added oversight, particularly for higher-risk devices.
Key Enhancements Introduced
- Harmonized real-world data collection to better detect emerging safety and performance concerns
- Expanded incident reporting to include serious side effects
- Trend and summary reporting, offering earlier detection of trends without excessive burden
- Stronger duties on risk mitigation and communication, helping safeguard patients
The new PMS regulation provides stronger data transparency, particularly for lower-risk devices, while building trust in the system through smarter surveillance practices.
Supporting Guidance and Background
The regulation is backed by updated guidance released in January 2025 and refined with industry input. It also builds on the Independent Medicines and Medical Devices Safety (IMMDS) Review, reinforcing the UK’s commitment to patient-first regulation.
Manufacturers can refer to the following for implementation:
These resources clarify reporting timelines, document submission formats, and risk communication expectations under the new framework.
Official Source: First major overhaul of medical device regulation comes into force across Great Britain
Published by MHRA on 16 June 2025
 Regulation Comes into Force Across Great Britain){kind=link}