Following legislation amendments (EU)2023/607, (EU)2024/1860 and new PMS regulations applicable in Great Britain, BSI is providing updated information on PSUR.
When available, the PSUR and the Notified Body evaluation report for Class III and Implantable and Class D devices will be uploaded to the European Database on Medical Devices (EUDAMED).
As of 16 June 2025, manufacturers placing devices on the Great Britain (GB) market shall also comply with the PSUR obligations as set out in UK MDR 2002 Part 4A, Regulation 44ZM (SI 2024/1368). These obligations apply irrespective of whether the subject devices are placed on the GB market based on EU legislations (Directives or MDR/IVDR) or the UK regulations.
The BSI PSUR evaluation process
Class III and Implantable devices (MDR and UKCA/Class D devices (IVDR) and Annex II List A and B devices (UK MDR)
The flow chart below shows the BSI PSUR evaluation process:
Neither the MDR, IVDR, UK MDR Part 4A nor MDCG 2022-21 or MHRA’s published guidance provide a specific timeline to prepare, issue and submit the completed PSUR after the end of the data collection period. However, BSI encourages manufacturers to prepare and issue their PSURs and to submit them to the Notified Body or Approved Body within 90 days of the end of the data collection period of the PSUR. Doing so will assist in the planning and completion of the evaluation activity, increasing predictability for clients.
A client’s PSUR-related procedures and the PMS Plan may be reviewed during surveillance activities to confirm adequate controls for the PSUR production and issuance are in place.
Class IIa non-implantable and IIb non-Implantable (MDR and UKCA) /Class C devices (IVDR)
Manufacturers of Class IIa and IIb non-implantable and Class C devices are also required to generate a PSUR. They shall be generated annually for Class IIb devices and Class C devices and every other year for Class IIa devices.
For these device classifications, the PSUR shall be submitted as part of the surveillance technical documentation assessments and will be considered within those assessments. A standalone PSUR evaluation report for these devices will not be provided.
Combined reviews of PSUR under MDR/IVDR and UKCA schemes
When a manufacturer has provided a single PSUR document to meet the PSUR obligations for the EU and Great Britain regulations, BSI will undertake a combined review of the PSUR.
Manufacturers are advised to clearly indicate the PSUR has been prepared to meet both EU and Great Britain requirements on the cover page and executive summary of the PSUR as well as identifying the Notified Body and Approved Body certificate numbers relating to the medical devices covered by the PSUR. As per MDCG and MHRA guidance, the devices in scope of the PSUR and the data collection period should be identified on the cover page.
The combined PSUR evaluation process will broadly follow the process set out in this communication. The technical specialist or clinical evaluation specialist will consider whether the requirements for both EU and Great Britain have been fulfilled, taking into consideration the guidance issued by the MDCG and MHRA as well as the text of the applicable legislations.
Where there is a requirement for a Notified Body Evaluation and an Approved Body report to be issued to the manufacturer, BSI will issue two separate reports with conclusions and actions specific to either the EU regulation certification or the UKCA certification.
PSURs for legacy devices placed on the market under MDD, AIMDD
For MDD/AIMDD devices, the Notified Body shall confirm through quality management audits that the manufacturer is generating a PSUR and has modified their post-market surveillance (PMS) system to meet the new requirements specified in the MDR.
MDCG 2021-25 states that manufacturers of legacy devices (those that are continued to be placed on the market during this transitional period under MDD/AIMDD) should NOT submit their PSUR to the Notified Body for evaluation unless requested. Therefore, manufacturers of legacy devices should not submit their PSUR to BSI for evaluation unless requested or the PSUR is being submitted because it is also valid for a UKCA-certified device.
Circumstances when BSI may request a legacy device PSUR for review:
Trends or concerns arising from BSI review of manufacturer’s vigilance data (serious incidents, trend reports, PSR, FSCA) reported to BSI or uploaded in EUDAMED
As a result of Competent Authority enquiries or other regulatory intelligence
Surveillance assessments under the applicable Directives in cases where the MDR technical documentation submission is significantly delayed or overdue
MDR certification has been achieved but the manufacturer has yet to place the device(s) on the market or put into service*
PSUR has been prepared by the manufacturer to meet the UK MDR 2002 Part 4A PSUR requirements
*As a result of extended transition timelines to comply with the MDR, as well as the extension in the validity of Directive certificates and sell-off period as per Regulation (EU) 2023/607, BSI has seen an increase in the number of MDR-certified devices which are not yet being placed on the market, yet manufacturers continue to place their Directive-certified devices on the market. As a Notified Body, BSI has obligations to conduct surveillance activities and post certification monitoring, including PSUR evaluations. Therefore, a manufacturer who has received MDR certification for a device(s) but has yet to place the device(s) on the market or put into service and has limited or no PMS data on the MDR device(s), may be requested to provide the legacy device PSUR to BSI as part of technical file surveillance.
PMS Reports and PSURs for legacy devices placed on the market under IVDD
MDCG 2022-08 states that manufacturers of IVDD legacy devices (those that are continued to be placed on the market during the transitional period) should continue to prepare a PMS Report and may voluntarily prepare a PSUR if desired. These PMS reports or PSURs should NOT be submitted to the Notified Body unless requested.
Circumstances when the PMS report or PSUR may be requested are aligned with the section on PSURs for legacy devices placed on the market under MDD/AIMDD.
PSUR requirements under UK MDR 2002 Part 4A
Please refer to the table below for scenarios when manufacturers are required to produce a PSUR which meets the UK MDR 2002 Part 4A Regulation 44ZM requirements, including when the PSUR is reviewed by the Approved Body.
Device certification status
Status on the market
Manufacturer’s PSUR obligations
Approved body review required
Device has UKCA certification issued by Approved Body and does not have any Directives-based CE or EU Regulations certification
Device DoC is signed and device(s) is placed on GB market/put into service in GB
PSUR compliant to Regulation 44ZM is required to be produced within one year (or two years for Class IIa devices) of the device being placed on the GB market or put into service in GB following the 16 June 2025
YES.
Approved Body must review the PSUR as per 44ZM paragraph (10)
Device has UKCA certification issued by an Approved Body, a Directives-based CE or EU Regulations certification is also held for the device
No devices placed on the GB market under the UKCA-certification.
Devices are placed on the GB market using the CE/MDR/IVDR certification
PSUR compliant to Regulation 44ZM is required to be produced within one year (or two years for Class IIa devices) of the device being placed on the GB market or put into service in GB following the 16 June 2025
YES.
Approved Body must review the PSUR as per 44ZM paragraph (10)
Note: Approved Body reviews the PSUR even if the Notified Body for the CE certification is a different organisation to the Approved Body
Device has UKCA certification issued by Approved Body, and Directives-based CE or EU Regulations certification is also held for the device
Devices placed on the GB market under the UKCA-certification
PSUR compliant to Regulation 44ZM is required to be produced within one year (or two years for Class IIa devices) of the device being placed on the GB market or put into service in GB following the 16 June 2025
YES.
Approved Body must review the PSUR as per 44ZM paragraph (10)
Note: Approved Body reviews the PSUR even if the Notified Body for the CE certification is a different organisation to the Approved Body
Device has a Directives-based CE and/or EU Regulations certification. Manufacturer has a signed contract with an Approved Body but UKCA certification has not yet been issued by the Approved Body. Conformity Assessment process has not started
Devices are placed on the market in GB using the CE/MDR/IVDR certification
PSUR compliant to Regulation 44ZM is required to be produced within one year (or two years for Class IIa devices) of the device being placed on the GB market or put into service in GB following the 16 June 2025
NO.
Approved Body does not review the PSUR as there are no surveillance activities being carried out at this time
Note: PSUR reviewed by the associated Notified Body as per EU regulation requirements
Device has a Directives-based CE and/or EU Regulations certification but no UKCA certification for the device is held
Devices are placed on the market in GB using the CE/MDR/IVDR certification
PSUR compliant to Regulation 44ZM is required to be produced within one year (or two years for Class IIa devices) of the device being placed on the GB market or put into service in GB following the 16 June 2025
NO.
There is no Approved Body and no UKCA certification
Note: PSUR reviewed by the associated Notified Body as per EU regulation requirements
Further information
For more information on BSI’s expectations for PSUR submissions, please listen back to our recent webinars using the following links:
Best Practice for PSUR: Listen Now
Prepare for the new Post-market Surveillance Requirements in Great Britain: Listen Now
