Page Last Reviewed: 12 January 2026

Background

The UK MHRA introduced a new Post-Market Surveillance (PMS) system via Statutory Instrument (SI) 2024 No. 1368. Its effective date is 16 June 2025.

Manufacturers already marketing CE marked devices in the EU were required to implement an MDR/IVDR compliant PMS system:

While significant portions of the two PMS requirements are the same, there are some differences, which we outline below.

Caveats

Vigilance Reporting

SI 2024 No. 1368 establishes requirements for PMS, vigilance reporting of serious incidents, trend reports, and field safety corrective actions (FSCAs). Under the MDR/IVDR, these items are addressed separately. Therefore, if manufacturers have separate vigilance reporting procedures, these must also be updated for compliance with SI 2024 No. 1368. Or, alternatively, ensure that UK vigilance reporting requirements are equally considered under the PMS procedure.

UK versus Great Britain

The UK is made up of four countries and all four countries have left the European Union:

Due to Brexit negotiations, Northern Ireland remains part of the European market and requires compliance with the MDR/IVDR. I.e., PMS requirements under SI 2024 No. 1368 are not applicable to devices placed on the market, or put into service, in Northern Ireland. Instead, MDR/IVDR requirements are applicable in Northern Ireland.

Therefore, it is recommended that PMS procedures/plans clearly address regulatory compliance for GB versus Northern Ireland (and EU).

Overview of Differences

UK References for PMS Procedure

References to relevant external documents, including PMS regulatory requirements and guidance, should be updated to add relevant UK MHRA references, including the below.

NOTE: The UK has its own regulatory framework for personal data (Data Protection Act 2018 (2018 c. 12)). Manufacturers for whom personal data is handled/managed by their devices, should strongly consider including provisions for reporting personal data breaches in their PMS system, if it is not already addressed under other QMS procedures. Personal data breaches in the UK must be reported to the Information Commissioner’s Office (ICO) using the ICO reporting tool. And assessments to determine breach reportability can be performed using the ICO self-assessment tool.

Terminology, Definitions, and Acronyms

There are some differences utilized between the EU and UK frameworks. For example:

UK SI 2024 No. 1368	EU MDR/IVDR
“Corrective action” means action taken in order to: eliminate the cause of a potential or actual non-conformity of a device; or reduce any other risk posed by a device, that has already been manufactured; may include recalling the device, withdrawing it from the market, and taking it out of service.	“Corrective action” means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
“Field Safety Corrective Action” (FSCA) means a corrective action taken by the manufacturer to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service.	“Field Safety Corrective Action” (FSCA) means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
“Incident” means in relation to a device that has been placed on the market or put into service: a malfunction or deterioration in the characteristics or performance of the device when used in accordance with the instructions for use; a side-effect that has a negative impact on—the health of an individual, patient management, or public health; an inadequacy in the design of the device, including an ergonomic feature, to enable the user to use the device safely and as intended by the manufacturer; an inadequacy in the information supplied with the device by the manufacturer to enable the user to use the device safely and as intended by the manufacturer; or an erroneous result provided by a diagnostic medical device, which informs a decision in relation to medical treatment.	“Incident” means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
“Lifetime of a device” means the shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended.	No corresponding formal definition in the MDR/IVDR. However, MDCG 2022-21 (Rev. 0; December 2022) does provide additional context: ‘The lifetime of a device is the time period specified by the manufacturer in the device documentation during which the device is expected to remain safe and effective for use / in use.’
“PMS period” means the period: beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, and ending with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later.	No corresponding formal definition in the MDR/IVDR. However, MDCG 2022-21 (Rev. 0; December 2022) does provide additional context: ‘A PSUR is no longer required to be updated when the last manufactured device of the device model has been placed on the market and the intended lifetime of that (individual) device; i.e. the overall lifetime of the device (model), has been achieved. The overall lifetime of a device (model) should include the time between the placing on the market of the last manufactured device and the end of the intended lifetime of that (individual) device.’
“Post-market surveillance” (PMS) means activities carried out by manufacturers to proactively collect and review experience gained from devices placed on the market or put into service for the purposes of identifying any need to apply corrective or preventive actions.	“Post-market Surveillance” (PMS) means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.
“Preventive action” means action taken by the manufacturer before completion of the manufacturing phase in order to eliminate the cause of a potential non-conformity or reduce a potential risk that could be posed by the finished device.	No corresponding formal definition in the MDR/IVDR.
“Required risk analysis” means the analysis required to weigh the risks posed by a device against the intended performance and benefits for the purposes of confirming conformity with the relevant essential requirements.	No corresponding formal definition in the MDR/IVDR.
“Serious deterioration of any person’s state of health” means any of the following— life-threatening illness or injury; permanent impairment of a body structure or a body function; hospitalisation or prolongation of hospitalisation; medical treatment, including surgical intervention and self-administered treatment, that is required to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; chronic disease; foetal distress, foetal death or a congenital physical or mental impairment or birth defect.	No corresponding formal definition in the MDR/IVDR. However, MDCG 2023-3 (Rev. 2; January 2025) provides the following:   ‘A serious deterioration in the state of health of a patient, user or other person can include: I. a life-threatening illness or injury, II. temporary or permanent impairment of a body structure or a body function, III. a condition necessitating hospitalisation or prolongation of existing hospitalisation, IV. medical or surgical intervention to prevent I or II, examples of this can be: professional medical care or additional unplanned medical treatment, a clinically relevant increase in the duration of a surgical procedure V. a chronic disease, VI. foetal distress, foetal death or any congenital abnormality (including congenital physical or mental impairment) or birth defects.   Please note that any indirect harm that may occur as a consequence of a medical decision or action taken/not taken on the basis of information or result(s) provided by a device can also lead to serious incidents, including a serious deterioration in a person’s state of health.’
“Serious incident” means an incident that directly or indirectly led, might have led or might lead to any of the following: the death of any person; the serious deterioration of any person’s state of health; a serious public health threat.	“Serious incident” means any incident that directly or indirectly led, might have led or might lead to any of the following: the death of a patient, user or other person, the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, a serious public health threat.
“Serious public health threat” means an event which could result in a risk: of death, serious illness, or serious deterioration of any person’s state of health; that affects a significant population; and that requires prompt remedial action.	“Serious public health threat” means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.
“Similar device” means a device which: has the same or a similar intended purpose; and is based on the same or similar technology.	No corresponding formal definition in the MDR/IVDR.

PMS Responsibilities

Manufacturers should ensure the UK PMS compliance responsibilities are clearly established in the PMS procedure/plan, such as responsibilities for reporting to the UK MHRA.

UK Responsible Person/Approved Body

Provisions on communication with your UK Responsible Person (UKRP) and/or UK Approved Body (UKAB) should be addressed in the PMS procedure/plan.

Manufacturers located in the UK are not required to appoint a UKRP. All others require a UKRP in order to legally market in Great Britain.

Manufacturers leveraging their CE Marking to register in Great Britain do not require a UKAB. The MHRA has implemented a transition period, and CE Marked devices are accepted until 2028-2030 (timeframe depends on type of device).

Timeframes to Provide PMS Data to MHRA

There is a strict timeframe for manufacturers to provide PMS information to the UK MHRA, upon request, of three (3) UK working days.

“The manufacturer and the UK responsible person (if there is one) must provide the PMS plan, including any post-market surveillance reports or periodic safety update reports and any reports issued by an approved body, to the Secretary of State upon request and within 3 working days of the date of any such request.”

This is opposed to the MDR/IVDR, which does not establish an explicit timeframe.

Device Lifetime & PMS Period

The UK PMS Plan must establish the device lifetime and PMS period for the subject device/device family.

Such a requirement is only inferred under the MDR/IVDR, with no explicit requirement established. However, MDCG 2022-21 (Rev. 0; December 2022) does provide additional context on “Device Lifetime” expectations:

“PSUR is required throughout the lifetime of the device: The lifetime of a device is the time period specified by the manufacturer in the device documentation during which the device is expected to remain safe and effective for use / in use. If the lifetime exceeds the administrative provisions in Annexes IX, X, XI, XIII of MDR, i.e. max 10 years for non-implantable devices and max 15 years for implantable devices, then the shorter timeline between the lifetime of the device and the retention period should prevail.”

As well as on the “end of the PSUR requirement”:

“A PSUR is no longer required to be updated when the last manufactured device of the device model has been placed on the market and the intended lifetime of that (individual) device; i.e. the overall lifetime of the device (model), has been achieved. The overall lifetime of a device (model) should include the time between the placing on the market of the last manufactured device and the end of the intended lifetime of that (individual) device.”

	UK SI 2024 No. 1368	EU MDR/IVDR Guidance
Device Lifetime	“Lifetime of a device” means the shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended.	The lifetime of a device is the time period specified by the manufacturer in the device documentation during which the device is expected to remain safe and effective for use / in use.
PMS Period	“PMS period” means the period: beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, and ending with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later.	A PSUR is no longer required to be updated when the last manufactured device of the device model has been placed on the market and the intended lifetime of that (individual) device; i.e. the overall lifetime of the device (model), has been achieved. The overall lifetime of a device (model) should include the time between the placing on the market of the last manufactured device and the end of the intended lifetime of that (individual) device.

PMS Reporting

The MDR/IVDR and SI 2024 No. 1368 both establish the same timeframe to prepare and update Periodic Safety Update Reports (PSURs). However, unlike the MDR/IVDR, SI 2024 No. 1368 also stipulates a PMS Report timeframe for Class I devices and Class A and B IVDs.

Device Class	UK SI 2024 No. 1368 Timeframe	EU MDR/IVDR Timeframe
Class IIb and III devices and Class C and D IVDs	Every (1) year	Every (1) year
Class IIa devices	Every (2) two years	Every (2) two years
Class I devices and Class A and B IVDs	Every (3) three years	“The report shall be updated when necessary…”

Device Bundling

SI 2024 No. 1368 details the criteria for manufacturers to prepare a single PSUR for a category or group of devices. It may be done if:

NOTE: “Similar device” means a device which has the same or similar intended purpose and is based on the same or similar technology.

The MDR/IVDR only briefly touches on this point under Article 86(1). However, MDCG 2022-21 (Rev. 0; December 2022) expands on this under Section 4, Grouping of devices.

“According to Article 86(1), a same PSUR may cover a “category or group of devices”. As a consequence, multiple Basic UDI-DIs (or device families) may be covered in one PSUR. Nevertheless the manufacturer should demonstrate the relevance of the grouping of several devices within the same PSUR by providing a justification.”

Field Safety Corrective Actions (FSCAs)

Manufacturers who undertake FSCAs outside of Great Britain (GB) must notify the UK MHRA within 3 UK working days, if the FSCA relates to a device which is of the same model as the device that has been placed on the market in Great Britain. This is even if the devices supplied in GB are not affected.

The manufacturer must provide the Field Safety Notice (or equivalent) and the initial FSCA Report Form (FSCARF) via [email protected] rather than the MORE portal.

NOTE: The UK MHRA considers devices that only differ by the name under which they are marketed in different geographical locations, to be the same ‘type’.

This language is different from the MDR/IVDR requirements. The MDR/IVDR states that the FSCA only needs to be reported in the EU if the reason for the FSCA is not limited to the device made available in the third country.

UK Only PMS Procedure/Plan Templates

The above information is for companies wishing to modify their existing MDR/IVDR PMS Procedure and Plan to include UK SI 2024 No. 1368 requirements.

If you wish to implement a UK specific PMS Procedure/Plan, Casus has free templates available for download: HERE