Post-market surveillance (PMS) of Medical Devices in Great Britain plays a key role in ensuring user safety and compliance.
With the entry into force on June 16, 2025, of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, medical device manufacturers in Great Britain face new and more stringent requirements.
The amendment represents the first concrete step in the post-Brexit reform for Medical Devices in Great Britain and paves the way for further regulatory updates planned for 2025 and 2026. Understanding and adjusting to the new PMS rules for Medical Devices in Great Britain is not only an obligation, but also a strategic opportunity to preside over a competitive market.
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: Goals
The Amendment The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduces a new Part 4A to the existing UK Medical Devices Regulations (MDR) 2002, focusing on Post-Market Surveillance requirements for Medical Devices in Great Britain (England, Scotland and Wales).
The new provisions apply to all Medical Devices placed on the market in Great Britain, including in vitro diagnostic Medical Devices (IVDs) and active implantable Medical Devices, irrespective of PMS activities already carried out by manufacturers in other countries, such as the European Union.
The measures introduced are aimed at improving the traceability of incidents and trends, enabling the Medicines and Healthcare products Regulatory Agency (MHRA) to intervene promptly when necessary. This contributes to more effective risk management, facilitates the early identification of security problems and their rapid mitigation, resulting in a reduction of potential damage.
Main novelties for Post-Market Surveillance in Great Britain
The new provisions present significant novelties for the Post-Market Surveillance of Medical Devices in Great Britain, particularly regarding the timing of reporting and incident management.
1. Supervision: stricter reporting deadlines
- Serious threat to public health: report to the MHRA within 2 working days of knowledge of the fact.
- Death or serious and unforeseen worsening of the state of health: report to the MHRA within 10 working days of knowledge of the fact.
- Expected serious worsening of the health condition: reporting within 15 working days of knowledge, a considerable reduction from the previous 30 days.
- Manufacturers are responsible for investigating accidents and must provide any information requested by the MHRA within three working days.
In addition, foreign manufacturers not established in the UK are obliged to inform their UK Responsible Person, i.e. the figure responsible for regulatory compliance for Medical Devices placed on the UK market.
2. Corrective Actions (FSCA) and Safety Notices (FSN)
- Field Safety Corrective Actions (FSCAs) must be communicated to the MHRA before or simultaneously with their implementation.
- If the MHRA requests updates, the manufacturer is obliged to provide the information within three working days.
- All FSCAs must be communicated to affected customers using a Field Safety Notice (FSN).
- Safety Notices must be easy to find, clear, concise, without commercial messages, must include UDI, MHRA registration number (if available), description of the problem, required action and must effectively reach all end users. It is good practice to publish them on your website to ensure traceability and monitor the effectiveness of communication.
- If a Safety Corrective Action (FSCA) is taken outside Great Britain – excluding Northern Ireland – for devices similar to those also distributed in Great Britain, the MHRA must still be informed within 3 working days.
The requirements reflect greater transparency and traceability, raising the standards of manufacturer responsibility.
3. PMS and PSUR documentation: a proactive and verifiable system
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduce the requirement for a documented and risk-proportionate Post-Market Surveillance Plan (PMS Plan) for all devices, a requirement that was not always equally provided for and structured before.
- The MHRA can request the PMS Plan and, if applicable, the PSUR (Periodic Safety Update Report) at any time.
- Documents must be made available within 3 working days upon request of the authority
4. MORE system: mandatory digital reporting
All reports must be submitted via the Manufacturer Online Reporting Environment (MORE) The portal supports the sending of
- Accident information, such as Manufacturer Incident Reports (MIR).
- Survey results.
- Corrective actions taken.
The MHRA has published useful Guidelines on the use of XML files (XSD) for MIR and FSCA reports in the MORE system, valid for Great Britain.
UK Responsible Person: more responsibility
The responsibilities of the UK Responsible Person (UKRP) expand and become crucial to the proper management of Post-Market Surveillance of Medical Devices in Great Britain. The UKRP must request, maintain and monitor the PMS plans and any PSURs of the manufacturers it represents, ensuring compliance. In addition, manufacturers are obliged to inform the UKRP of any importer operating in the UK and to report any new appointment or removal promptly.
Conclusions and Implications for Manufacturers
The new Post-Market Surveillance framework for Medical Devices in Great Britain, introduced by the Medical Devices (Amendment) 2024, aims to close historical gaps with a more rigorous approach. Although inspired by international best practice and European regulations, significant differences remain, so a strategic approach is needed, combining international harmonisation and specific adaptation to British standards.
Medical Device manufacturers must adapt to the new regulations promptly in order to maintain their presence in the UK market.
>>> For support in compliance with Great Britain regulations, Thema, as UK Responsible Person, offers strategic regulatory consulting throughout the medical device lifecycle, including the Post-Market Surveillance phase.
Useful sources and resources:
GB MIR and FSCA scheme implementation guide – GOV.UK
Post-market surveillance requirements for Medical Devices: summary of main changes – GOV.UK
GB MIR and FSCA schema implementation guide
06/10/2025
