Guidance
Post-market surveillance requirements for medical devices: summary of main changes
Published 15 January 2025
Applies to England, Scotland and Wales
© Crown copyright 2025
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The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
Summary of main changes introduced with the statutory instrument (SI) and associated guidance
| Section of the guidance | Regulation of the SI | Change introduced with the SI/associated guidance compared to prior regulation/associated guidance | 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 that interventions to prevent serious deterioration in health include self-administered treatment | Manufacturer |
| C | 44ZE | Requirement for a PMS plan now mandatory within the regulations | Manufacturer |
| C a) (i) | 44ZF | Clarification that feedback should include patient and public engagement. | Manufacturer |
| C b) (i) | 44ZG 2 | Requirement to inform the UK RP and AB (where have one) of all preventive and corrective actions taken to address a risk or non-conformity compromising the performance or safety of the device | Manufacturer |
| C b) (i) | 44ZG 3 | AB to review CAPA for impact on certification | Approved Body |
| C c) | 44ZL and 44ZM | Provision of PMSR or PSUR to MHRA on request within 3 working days | Manufacturer |
| C c) (i) | 44ZL and 44ZM | Timing of requirement to prepare first PMSR, and to update at least every 3 years | Manufacturer |
| C c) (ii) | 44ZL and 44ZM | Preparation of a PSUR to a standardised format, updated at set intervals | Manufacturer |
| C c) (ii) 2 | 44ZL and 44ZM | Submission of PSUR to approved Body | Manufacturer |
| C c) (ii) 2 | 44ZL and 44ZM | AB to review PSUR for any impact on device certification | Approved Body |
| C c) (ii) 2 | 44ZL and 44ZM | AB to prepare a report on review of PSUR for certain device classifications | Approved Body |
| D c) | 44ZC | Serious deterioration in health need not have occurred for a use error to be reportable, just the risk it could occur. | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D d) | 44ZH(3)(b) | 15 days to report anticipated serious deterioration in health (was 30). | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D f) | 44ZH(2)(d) | Inclusion of UDI (where available) within the incident report | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D g) & D j) | 44ZI(3)(b) 44ZJ(8) | Provide MHRA within 3 working days any information requested relating to an ongoing incident investigation or FSCA. | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D g) | 44ZI(3)(c) | Detailed requirements on commencement of destructive device testing following notification to MHRA of intention to do so. | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D g) | 44ZO | Detailed requirements on action in response to notification of an incident by MHRA | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D g) | 44ZP(2) | Investigation and reporting in response to risk or safety concern MHRA brings to manufacturer’s attention | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D i) | 44ZN(1) | Trend reports should be submitted for incidents which are reportable individually, as well as those which do not meet the criteria for individual reporting | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D i) | 44ZN(5) | Detailed requirements for information to be included within a Trend report. Note UDI field not visible yet. | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D i) | 44ZD(2) | Trend reports are not required for custom-made devices | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D j) | 44ZJ(1) and (3) | Requirement to submit proposed FSN to MHRA prior to sharing with customers. And detailed requirements on subsequent timing of distribution to affected customers. | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D j) | 44ZJ(6)(a) | The FSN must contain UDI information where available and must be sent in a searchable format. | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |
| D j) | 44ZK(1) | If the manufacturer is undertaking FSCA outside Great Britain and the same type of devices are supplied in Great Britain but are not affected, they must notify MHRA | Manufacturer or delegated to UK Responsible Person (UKRP) or Authorised Rep for NI |