MHRA Performance Data
Page summary:
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
Change made:
Performance data published for May 2025.
Time updated:
9:33am, 16 June 2025
Medical devices: examples of reportable incidents
Page summary:
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Change made:
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 16 June 2025
Field safety notice (FSN): what it is and why it’s important
Page summary:
A flyer to circulate to customers alongside a field safety notice covering what it is and why it’s important to take action.
Change made:
published new version of flyer.
Time updated:
10:00am, 16 June 2025
Medical devices: post-market surveillance requirements
Page summary:
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Change made:
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 16 June 2025
Custom-made medical devices in Great Britain
Page summary:
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Change made:
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 16 June 2025
Field safety notices: guidance for manufacturers
Page summary:
How to write clear and effective field safety notices (FSNs) for medical devices.
Change made:
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 16 June 2025
Medical devices: post-market surveillance
Page summary:
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
Change made:
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 16 June 2025
First major overhaul of medical device regulation comes into force across Great Britain
Page summary:
New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
Change made:
First published.
Time updated:
11:16am, 16 June 2025
Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation
Page summary:
New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.
Change made:
First published.
Time updated:
10:58am, 18 June 2025
Medical devices: periodic safety update report
Page summary:
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Change made:
Added periodic safety update report
Time updated:
4:24pm, 18 June 2025
The Innovative Devices Access Pathway (IDAP)
Page summary:
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Change made:
Attachment added – The IDAP Unmet Clinical Need Authorisation (UCNA)
Time updated:
4:49pm, 19 June 2025
