From 16 June 2025, the Medical Devices Post-market Surveillance (PMS) Regulations apply to medical devices and IVDs placed on the market in Great Britain. Published in 2024, the new UK PMS Regulations amends the UK Medical Devices Regulations (MDR) 2002.
Changes for manufactures of medical devices and IVDs
The Regulations bring some key changes for PMS processes. They apply to both UKCA and CE-marked devices. Among the main changes, drafting a PMS plan is now mandatory. The PMS plan has to include at least the following:
- PMS system objectives
- Processes to gather information
- Data analysis’ methods
- Vigilance reporting obligations
- Preventive and corrective actions as part of a risk management process
Other changes include:
- Mandated post-market surveillance reports (PMSR) and periodic safety update reports (PSUR), depending on the device class.
- Definition of “post-market surveillance period”, “serious incident”, “life-time”
- Stricter serious incident reporting obligations
- Defined obligations when conducting a Field Safety Corrective Action (FSCA)
- Detailed requirements relating to Field Safety Notices (FSN)
- Stricter requirements for manufacturers when conducting reviews of their PMS data.
Updates of MHRA guidance documents
In June 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance documents. In particular, the updates include revised PMS guidance, Manufacturer Incident Reports (MIRs), and Field Safety Corrective Action Reports (FSCAs).
Pathways to enter the UK market
To enter Great Britain (England, Scotland, and Wales), the UK recognises both CE and UKCA marks, while Northern Ireland recognizes CE or UKNI mark. For Great Britain, a UK responsible person is always required, independently from the compliance process.
Do you have any questions on compliance of cosmetics in the EU, UK, US, or Canada? Get in touch.
References:
Gov.uk (2025). Medical devices: post-market surveillance. Retrieved on 24/06/2025.
Regulatory Intelligence & Innovation Junior Consultant
24/06/2025