MHRA guidance on new UK PMS Regulations

The Medical Devices Post-market Surveillance Requirements Regulations 2024 amends the UK Medical Devices Regulations (MDR) 2002 and includes a new section on post-market surveillance (PMS) requirements for medical devices. The Regulations apply also to in vitro diagnostic (IVD) devices and active implantable medical devices. The new Regulations apply from 16 June 2025.

In June 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance document on the new Post-Market Surveillance requirements. Specifically, the new revision includes an overview of documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations.

Main changes introduced by the new PMS Regulations

Compared to the previous Regulations, drafting a PMS plan is now mandatory. The minimum aspects to address in the PMS plan are:

• PMS system objectives
• Processes to gather information
• Data analysis’ methods
• Vigilance reporting obligations
• Preventive and corrective actions as part of a risk management process

A post-market surveillance reports (PMSR) and periodic safety update reports (PSUR) are also mandated by the new Regulations, depending on the device’s class.

Overview of documents on PMS requirements in Great Britain

With the latest update, the MHRA provides documentation to support changes made to reporting Manufacturer Incident Reports (MIRs), and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices, which can be accessed here.

In addition, the Agency gives access to (not exhaustive list):

• A supplementary guidance on a manufacturer’s vigilance system, including a guidance on effective field safety notices  and examples of incidents which should be reported under the vigilance system
• Guidance on the Manufacturers online reporting environment (MORE)
• MIR and FSCA schema implementation guide
• Implementation of data requirements under the new Post-Marketing Surveillance regulations
• Device-specific vigilance guidance
• Field safety notices: guidance for manufacturers

Our MDlaw library of documents provides a full overview of all relevant guidance documents for manufacturers. For any questions or support on compliance of medical devices, contact us.

References:

Gov.uk (2025). Medical devices: post-market surveillance. Retrieved on 11/06/2025.