New UK PMS Update to the Medical Devices Regulations 2024

The passing of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which amends the UK Medical Devices Regulations (UK MDR) 2002 by inserting a new Part 4A on PMS requirements for medical devices, including IVD devices and AIMD, is now in force as of 16 June 2025. These new measures aim to facilitate greater traceability of incidents and trends and support better risk management, containment of safety issues, and reduce harm. In alignment with these requirements, the MHRA has enhanced its processes for identifying potential risks and safety concerns in medical devices, resulting in updated data schemas for Manufacturer Incident Reports (MIR) and Field Safety Corrective Action (FSCA) reports, which improve data quality and support submissions under the new regulations.  

Key Changes Introduced by the New UK PMS Regulation 

• Timelines for reporting serious incidents (reporting timeline decreased from 30 to 15 days). 
• The obligation to establish a Post-Market Surveillance (PMS) system that actively collects and evaluates data on devices available in the markets.  
• The requirement to report notable rises in the frequency or severity of incidents involving a device, if the manufacturer believes that such an increase could significantly affect the risk assessment. More detailed information can be found here: New Post-Market Surveillance Rules for UK Medical Devices – MedEnvoy 

Manufacturer’s Online Reporting Environment

As of 16 June 2025, Manufacturer’s Online Reporting Environment (MORE), incorporates these new schemas for user acceptance testing, with updates to webforms and APIs for GB submissions. The new GB data schemas are now operational in the MORE production environment, allowing compliance with the new regulations. Existing EU schemas will remain available for non-GB submissions, as Northern Ireland (NI) must still follow the PMS rules set out in the EU MDR and detailed in guidance on the Regulation of devices in Northern Ireland. Manufacturers using APIs must update their systems to align with the new schemas.  

Users of MORE should continue to refer to the MORE Registrations – user reference guide and MORE Submissions – user reference guide, which will be updated to reflect the new requirements. In the MORE portal, registered users can submit data through manual entry via web forms, XML report uploads, or APIs. The available web forms include: 

• Manufacturer Incident Reports (MIR)  
• Field Safety Corrective Actions (FSCAs) 
• Trend Reports 
• Periodic Summary Reports (PSRs) 
• Serious Adverse Events (SAEs).  

Notably, updates to the MIR and FSCA report schemas include collection of information more specifically for the GB market, such as collection of contact information for the UKRP, identification of the UK Approved Body (UKAB) ID and certificate numbers, and removal of references to EUDAMED (MIR only). Trend Reports, PSRs, and SAEs remain unchanged.  

To facilitate comparison with the existing MIR 7.2.1 schema, the MIR help text has been annotated to highlight changes to the fields. Differences between the EU MIR 7.2.1 and the GB schema can be found in the tab labeled ‘7.2 Help text GB’. Be aware that some elements within the xsd will be modified, which are not included in the current help text. For a detailed list of each modification to the MIR xsd, please refer to the GB MIR and FSCA schema implementation guide. 

Please note that PDF format is not a supported submission method and has not been since the launch of the current MORE portal in 2022. Submissions must be made through MORE, and reports can be sent via API, post, or webform. 

Field Safety Notices and Periodic Safety Update Reports

The MHRA guidance on how to write clear and effective FSNs for medical devices has been updated to reflect the coming into force of the Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024 and provides supplementary information and advise on how to create and distribute effective FSNs.  These updates form part of the broader implementation of the UK PMS Regulation, aimed at improving post-market safety communication.

The MHRA has also released an updated guidance “Medical Devices Periodic Safety Update Report (PSUR),” which was first published in January 2025. The guidance is intended to instruct manufacturers on the data to include within a PSUR. 

Implementation Steps and Resources

To ensure compliance with the new UK PMS regulations, manufacturers should utilize the provided resources to update systems and processes according to the GB xsd schemas. Submissions under the PMS legislation for Great Britain must use the GB schemas, with the correct schema included in the xml header. Reports for Northern Ireland can continue to follow EU requirements.  

If submitting a new report related to a previously submitted MIR or FSCA, users should update the schema per the new requirements, and it will be linked in the MHRA system as usual. Initially, it is permissible to submit the first report using the EU schema and a subsequent report using the GB schema. During the transition period, submissions can be made using either the EU or new GB schemas, provided additional required information is included (outlined in tables 2 and 3 of the guidance), until 16 October 2025. After this period, the GB schema must be used to meet reporting obligations under the PMS legislation. This phased approach aims to facilitate a smooth transition while ensuring regulatory compliance. 

The MHRA provides supporting documentation to assist users of MORE in implementing the new Post-market Surveillance (PMS) regulations. This documentation includes an overview of the changes made, an updated submissions guidance document, a bridging document for MIR helptext, updated xsds, and example xmls.  

Support is available via email at aic@mhra.gov.uk, using the subject heading “PMS implementation information request: Entity Name.” 

Learn More About UK PMS Regulations with MedEnvoy

At MedEnvoy, we understand that navigating the complexities of UK PMS regulations can be daunting. That’s why we are committed to guiding you every step of the way. Whether you are looking to ensure full compliance with UK MDR 2002, seeking tailored market strategies, or support with MORE registration, our team is here to support you. 

Contact us to speak with our regulatory experts and learn how we can support your MHRA PMS efforts.