Changes to Post-Market Surveillance (PMS) requirements: What you need to know - Part two

In this second part of his exploration of the upcoming changes to Post-Market Surveillance (PMS) requirements for medical devices and in vitro diagnostics in the United Kingdom, Mike Picchioni, Associate Director of Regulatory Affairs at G&L Scientific, examines the key differences between the UK Statutory Instrument 2024 No. 1368 and the EU regulations.

Statutory Instrument 2024 No. 1368 on Post-market Surveillance (PMS) Requirements for Medical Devices and In Vitro Diagnostics was published on December 16, 2024, and will come into force on June 16, 2025.

These changes will apply to medical devices, in vitro diagnostic (IVD) devices, and active implantable medical devices in Great Britain (England, Scotland, and Wales). Notably, products sold in Northern Ireland will continue to comply with the EU requirements.

This article examines the significant differences between the UK’s new regulations and the EU MDR and IVDR and explains how these changes will affect manufacturers in terms of compliance and reporting obligations.

Key differences between UK and EU regulations

While the requirements in the 2024 No. 1368 closely mirror those in the EU MDR and IVDR, some differences are worth noting.

Both regulations emphasize the need to gather, record, and analyze data on the safety, performance, and quality of devices throughout their entire lifecycle. However, the EU regulations lack a precise definition of “lifetime.”

In contrast, the UK legislation defines the lifetime of a device as the period starting from the first time a device model is placed on the market or put into service and ending with the last device’s use or market placement.

The UK also encourages manufacturers to continue PMS data collection beyond the typical device lifecycle, extending to the expected lifespan of the device when it remains in use. Manufacturers must use their real-world experience to determine the longest reasonably foreseeable period of use.

Another key difference lies in the definitions of “incident” with the UK regulation providing a more detailed definition.

The UK Statutory Instrument 2024 No. 1368 states: “An incident has occurred with a medical device in any one or more of the following circumstances:

• The device malfunctions or deteriorates in characteristics or performance in any way (when used as intended)
• If used for diagnosis, the device provides incorrect or inaccurate results that then support a clinical decision (including by the patient for self-testing devices)
• Identification of any shortcomings related to the device design or difficulty in using the device safely, which may give rise to use errors - this includes any inadequacies in information or instructions provided, as these are considered an integral part of the device
• Use of the device gives rise to a side effect that has a negative impact on the health of the patient, or their care, or on wider public health.”

MDR and IVDR simply define an incident as “any malfunction or deterioration in the characteristics or performance of a device, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.”

Serious incidents: Definitions and reporting requirements

Both the UK and EU regulations share common ground when defining a “serious incident.”

However, the UK’s Statutory Instrument 2024 No. 1368 offers a detailed definition of “serious deterioration of any person’s state of health” that includes life-threatening illness or injury, permanent impairment of a body structure or function, hospitalisation, medical treatment being required to prevent life-threatening illness or injury or permanent impairment of a body structure or function, chronic disease and foetal distress, foetal death or a congenital physical or mental impairment or birth defect and a serious public health threat.

Compared to the definition of a ‘serious incident’ as “any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat” in the MDR/IVDR.

Furthermore, the UK regulation introduces a broad definition of “preventive action” to include any action aimed at reducing a risk posed by a device, even when no non-conformity has occurred. This broader approach ensures that risk management is proactive rather than reactive, encouraging manufacturers to act before any issues arise.

Reporting

Requirements for reporting and investigation of serious incidents are similar in the EU and GB however Statutory Instrument 2024 No. 1368 mandates what information is to be included in the report, so manufacturers should check the list of required information before reporting serious incidents in GB.

The exception of expected and documented side-effects does not appear in the UK legislation.

The final report must be submitted to the MHRA via the MORE portal.

Post-market surveillance report (PMSR)

The requirements in EU and GB regulations overlap other than

• PMSR is required for Class I general medical devices (both in the EU and GB), or class A and B of the IVDR (EU) vs. Class A, B or non-Annex II (that is, not list A or B per IVD) (GB).
• The duration of the requirement is not specified in EU regulations. Timings are specified in GB: the PMSR must be produced within three years of the device being placed on the GB market or put into service, whichever is sooner, and updated every three years until the end of the PMS period for that device.

Periodic Safety Update Report (PSUR)

• The intervals for production of a PSUR differ: in the MDR Manufacturers of class IIb and class III devices shall update the PSUR at least annually. In IVDR Manufacturers of class C and D devices shall update the PSUR at least annually.

In the UK, the manufacturer of Class IIa devices must produce the first PSUR within 2 years of the device being placed on the market/put into service or, if already on the market, within 2 years of this regulation coming into force. For Class IIb and Class III medical devices and Class C and D, and Annex II (list A and B) IVDs the manufacturer must produce the first PSUR within 1 year of the device being placed on the market/put into service or if already on the market within 1 year of this regulation coming into force (see Saving Provision referenced above).

• In the UK, the requirement applies to each device or category or group of devices and not, as in the EU regulation, to each device and categories or groups of devices. Categories are determined by either: (i) if the devices are covered by the same clinical evaluation report under EU regulation; or (ii) if the devices have the same or a similar intended purpose and are based on the same or similar technology and the manufacturer considers that the similarity between the devices justifies a single PSUR.
• In addition to EU requirements, the GB PSUR needs to include: (i) a description of any preventive or corrective action and the rationale for doing so; and (ii) the conclusions of any post-market clinical follow-up required.

Additional information includes a description of the characteristics of the population using the devices, with estimates for numbers using the device in the UK and outside the UK, as well as how often they use the device.

• Each PSUR must be submitted to the approved body (if there is one) for review if the device is: (i) class III; (ii) implantable (including active implantable); or (iii) listed in Annex II of the in vitro diagnostic directive 98/79 (IVDD). The approved body must then issue a report to the manufacturer and any UKRP setting out its conclusions.
• The MHRA has also clarified that it will require where appropriate for a device that "patient and public engagement" (PPE) is required to identify improvements to meaningful outcomes for patient safety and public health.
• Similar incidents occurring outside Great Britain must be reported at the final reporting stage.

Trend reporting and retention of documentation

Both the EU and UK regulations have requirements for trend reporting.

However, the UK regulations go further by mandating a three-working-days deadline to respond to MHRA requests.

The UK regulations also require manufacturers to report any Field Safety Corrective Actions (FSCAs) taken outside Great Britain for the same model of device.

The retention periods for documentation are also different between the EU and UK regulations.

In the UK, the manufacturer and the UKRP (if there is one) must retain documentation until the later of: the PMS period for that device model or 15 years in the case of an implantable device or 10 years in the case of any other device.

This is different from the EU regulations for which the requirement is "10/15 years after the last device has been placed on the market". This makes the 10/15 years an absolute number and the period of use the more definitive figure for devices with greater longevity.

For devices with an expected "lifetime" beyond the 10/15 years (as applicable), the retention period will, therefore, be longer in GB.

Conclusion

The introduction of Statutory Instrument 2024 No. 1368 brings significant changes to post-market surveillance requirements for medical devices in Great Britain.

While many of the requirements align with EU regulations, the UK has implemented key differences that manufacturers must address to ensure compliance. These include more specific definitions of “incident” and “serious incident,” stricter timelines for PMSR and PSUR submission, and enhanced requirements for reporting and documentation retention.

Manufacturers should familiarize themselves with these changes well in advance of the regulations coming into force on June 16, 2025, to ensure a smooth transition and continued compliance.

By taking these steps now, manufacturers can ensure a smooth transition and avoid compliance risks under the new UK Post-Market Surveillance regulations.

Mike Picchioni is Associate Director of Regulatory Affairs at G&L Scientific.