On January 15th, the MHRA announced the following guidance on implementation regarding Post-market Surveillance (PMS) Requirements 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, 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 PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, which apply within Great Britain.
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).
|
Setion of Guidance |
Regulation of the SI |
Change Introduced |
Requirement Applies to |
|
B b) |
44ZC |
Definition of the Post-Market Surveillance Period |
Manufacturer |
|
B d), & D c) |
44ZC |
Definition for reportable side-effects |
Manufacturer |
|
B d), & D c) |
44ZC |
Clarification on interventions for serious health deterioration |
Manufacturer |
|
C |
44ZE |
Mandatory requirement for a PMS plan |
Manufacturer |
|
C a) (i) |
44ZF |
Clarification on feedback, including patient and public engagement |
Manufacturer |
|
C b) (i) |
44ZG 2 |
The requirement to inform UK RP and AB of preventive/corrective actions |
Manufacturer |
|
C b) (i) |
44ZG 3 |
AB review of CAPA for certification impact |
Approved Body |
|
C c) |
44ZL and 44ZM |
Provision of PMSR or PSUR to MHRA within 3 days |
Manufacturer |
|
C c) (i) |
44ZL and 44ZM |
Timing for first PMSR and updates every 3 years |
Manufacturer |
|
C c) (ii) |
44ZL and 44ZM |
Standardized PSUR format updated at intervals |
Manufacturer |
|
C c) (ii) 2 |
44ZL and 44ZM |
Submission and AB review of PSUR |
Manufacturer, Approved Body |
|
C c) (ii) 2 |
44ZL and 44ZM |
AB report on PSUR review for certain devices |
Approved Body |
|
D c) |
44ZC |
Use error reportability criteria |
Manufacturer, UKRP, orAuthorisedRep |
|
D d) |
44ZH(3)(b) |
Timeframefor reporting serious health deterioration |
Manufacturer, UKRP, or Authorised Rep |
|
D f) |
44ZH(2)(d) |
Inclusion of UDI in incident reports (where available) |
Manufacturer, UKRP, or Authorised Rep |
|
D g) & D j) |
44ZI(3)(b), 44ZJ(8) |
Timely provision of incident investigation info to MHRA |
Manufacturer, UKRP, or Authorised Rep |
|
D g) |
44ZI(3)(c) |
Detailed requirements for destructive testing |
Manufacturer, UKRP, or Authorised Rep |
|
D g) |
44ZO |
Action requirements post-MHRA incident notification |
Manufacturer, UKRP, or Authorised Rep |
|
D g) |
44ZP(2) |
Investigation and reporting on MHRA-notified risks |
Manufacturer, UKRP, or Authorised Rep |
|
Di) |
44ZN(1), 44ZN(5) |
Trend reporting criteria and requirements |
Manufacturer, UKRP, or Authorised Rep |
|
Di) |
44ZD(2) |
Exemption from trend reports for custom-made devices |
Manufacturer, UKRP, or Authorised Rep |
|
D j) |
44ZJ(1), 44ZJ(3) |
FSN submission and distribution requirements |
Manufacturer, UKRP, or Authorised Rep |
|
D j) |
44ZJ(6)(a) |
UDI inclusion in FSN and format requirements |
Manufacturer, UKRP, or Authorised Rep |
|
D j) |
44ZK(1) |
Notification requirement for non-affected devices in GB |
Manufacturer, UKRP, or Authorised Rep |
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 a comparison table available 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.