On January 15th, the MHRA announced the following guidance on implementation regarding Post-market Surveillance Requirements (PMS) in Great Britain.
This guidance is designed to help medical device manufacturers understand and prepare for the new PMS regulation for medical devices in Great Britain (GB), which will come into force on June 16, 2025.
A new set of regulations has been introduced that amends the UK Medical Devices Regulations (MDR) 2002. A new Part 4A is inserted on post-market surveillance (PMS) requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, which apply within Great Britain (GB).
Key new requirements are enhanced data collection, shorter timelines for reporting serious incidents and summary reporting to enable the MHRA and manufacturers to identify safety issues earlier, and clearer obligations for risk mitigation and communication to protect patients and users.
The PMS requirements cover the following, referencing the regulation of the statutory instrument 2024 No. 1368:
- 44ZC: Clarification of important terms
- 44ZE: Post-market surveillance syste
- 44ZF: Post-market surveillance plan
- 44ZG: Preventive and corrective actions
- 44ZH: Initial reporting of serious incidents
- 44ZI: Investigation and final reporting of serious incidents
- 44ZJ: Field safety corrective actions and field safety notices
- 44ZK: Field safety corrective actions outside Great Britain
- 44ZL: Post-market surveillance report
- 44ZM: Periodic safety update report
- 44ZN: Trend reporting
- 44ZO: Reports received by the Secretary of State
- 44ZP: Analysis of information received
- 44ZQ: Retention of post-market surveillance documentation
- 44ZR: Requests for post-market surveillance documentation
Below is a table summarizing the changes introduced with the new PMS requirements. The first column provides the reference to the associated guidance.
This table outlines the key regulatory changes and their implications for manufacturers, UK Responsible Persons (UKRPs), and Authorised Representatives (ARs).
This guidance document guides the interpretation of certain requirements in the regulation. It is not intended to address every requirement. The full text of the regulation can be found here: Statutory Instrument (SI) 2024 No. 1368, in which Chapter 4A covers the newly introduced PMS requirements. Qserve encourages manufacturers to review and implement the guidance promptly to ensure compliance by the June 16, 2025 deadline.
Qserve will make available a comparison table between the new PMS requirements for the UK and the existing PMS requirements in the EU (MDR/IVDR).
A gap analysis detailing the main differences and possible remediation between the two documents will be made available for Qserve UK RP customers.
This blog summarizes the changes in regulations in the UK. Full details, including more regulatory changes and impact assessments, can be found on the Qserve regulatory intelligence platform, Qserve InSight.
