Guidance

Post-market surveillance (PMS) obligations by medical device type

Published 15 January 2025

Applies to England, Scotland and Wales

© Crown copyright 2025

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This publication is available at https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type

These requirements do not apply to devices subject to clinical investigation, performance evaluation or exceptional use authorisation in Great Britain (GB). They also do not apply to medical devices manufactured in house by healthcare establishments (regardless of whether custom made) which should follow the existing guidance on in-house manufacture of medical devices in Great Britain on the MHRA website.  

Type of device Relevant part and regulation of UK MDR 2002 Basis for conformity assessment (UKCA, EU MDD/IVDD/AIMDD or EU MDR/IVDR) PMS System (Reg 44ZE) PMS Plan (Reg 44ZF) Corrective and Preventative Actions (Reg 44ZG) Initial reporting of serious incidents (Reg 44ZH) Investigation and final reporting of serious incidents (Reg 44ZI) FSCA & FSN (Reg 44ZJ) FSCA outside of Great Britain (Reg 44ZK) PMS reports (Reg 44ZL) PSUR reports (Reg 44ZM) Trend Reporting (Reg 44 ZN) Reports from HCPs, user, patients (Reg 44ZO) Analysis of information under Part 4A (Reg 44ZP) Retention of PMS documentation (Reg 44ZQ)
General medical device Part 2 UKCA All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class I Class IIa, IIb, III All risk classes All risk classes All risk classes All risk classes
General medical device Part 2, Regulation 19B EU MDD All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class I Class IIa, IIb, III All risk classes All risk classes All risk classes All risk classes
General medical device Part 2, Regulation 19C EU MDR All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class I Class IIa, IIb, III All risk classes All risk classes All risk classes All risk classes
Active Implantable medical devices Part 3 UKCA Class III Class III Class III Class III Class III Class III Class III N/A Class III Class III Class III Class III Class III
Active Implantable medical devices Part 3, Regulation 30A EU AIMDD Class III Class III Class III Class III Class III Class III Class III N/A Class III Class III Class III Class III Class III
Active Implantable medical devices Part 3 EU MDR Class III Class III Class III Class III Class III Class III Class III NA Class III Class III Class III Class III Class III
In Vitro Diagnostic devices Part 4 UKCA All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes General IVD List A, List B All risk classes All risk classes All risk classes All risk classes
In Vitro Diagnostic devices Part 4, Regulation 44ZA EU IVDD All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes General IVD List A, List B All risk classes All risk classes All risk classes All risk classes
In Vitro Diagnostic devices Part 4, Regulation 44ZB EU IVDR All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class A, B Class C and D All risk classes All risk classes All risk classes All risk classes
Custom Made devices Part 2 UKCA All risk classes All risk classes2 All risk classes All risk classes All risk classes All risk classes N/A N/A N/A N/A All risk classes All risk classes All risk classes
Custom Made devices Part 2 EU MDD1 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Custom Made devices Part 3 EU AIMDD1 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Custom Made devices Part 2, Regulation 19C EU MDR All risk classes^ All risk classes2 All risk classes All risk classes All risk classes All risk classes N/A N/A N/A N/A All risk classes All risk classes All risk classes
Systems and procedure packs Part 2 UKCA All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class I3 Class IIa, IIb and III3 All risk classes All risk classes All risk classes All risk classes
Systems and procedure packs Part 2, Regulation 19B EU MDD All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class I3 Class IIa, IIb and III3 All risk classes All risk classes All risk classes All risk classes
Systems and procedure packs Part 2, Regulation 19C EU MDR All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes All risk classes Class I3 Class IIa, IIb and III3 All risk classes All risk classes All risk classes All risk classes

1 Manufacturers can no longer place an EU AIMDD or EU MDD compliant custom-made device on the GB market (or EU or Northern Ireland). This has been the case since 26 May 2021 and the PMS SI doesn’t change this – it allows for continued acceptance of CE marked and EU compliant devices currently permitted on the GB market 

2 Custom made devices are exempt from the following requirements of the PMS Plan: paragraphs 3, g & h 

3 Only applies to system or procedure packs which are required to be either UKCA or CE-marked in order to be placed on the market.

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