Changes to PMS requirements: What you need to know

Here, the key differences between 2024 No. 1368 and the Medical Devices Regulations 2002 are examined with a comparison of 2024 No. 1368 with EU Regulation (EU) 2017/745 to follow in the next instalment.

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 take effect on June 16, 2025.

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Devices Regulations (MDR) 2002 by introducing a new Part 4A on PMS requirements.

These changes apply to medical devices, in vitro diagnostic (IVD) devices, and active implantable medical devices in England, Scotland, and Wales.

Products sold in Northern Ireland must continue to comply with EU requirements.

Under the new regulations, manufacturers must establish a system for gathering and analyzing feedback and complaints to ensure their devices consistently meet appropriate performance and safety standards.

The updated requirements now explicitly extend to in vitro diagnostic devices and active implantable medical devices.

One of the most significant changes under the new regulation is the requirement for manufacturers to incorporate PMS data into their risk management processes.

This data must be used to update technical documentation for UKCA-marked devices, and the MHRA expects manufacturers to apply similar principles when updating CE-marked device documentation for the GB market.

The regulation also provides a clear definition of the post-market surveillance period, which begins when a device is first placed on the market or first put into use, whichever occurs first, and continues until the end of the lifetime of the last device placed on the market or in service.

However, the MHRA emphasizes that the foreseeable period of use may extend beyond the device lifespan, and manufacturers should use real-world data to determine the longest reasonably foreseeable period of use and adjust their surveillance periods accordingly.

The 2024 No. 1368 regulation introduces a new definition of a serious incident, which must meet three criteria. First, an event must have occurred, or an issue must have been identified. This can include findings from device testing, examination of accompanying information, or any scientific data indicating a potential issue.

Second, the manufacturer’s device must be suspected of being a contributory cause, including as a known side effect.

Third, the event must have resulted, or could have resulted, in death or serious deterioration in the health of a patient, user, or any other person.

Manufacturers are now required to define their Post-market Surveillance system within a PMS plan, which must be proportionate to the risk level of the device.

The PMS plan must include objectives, methods for gathering information, processes for analyzing data, fulfillment of vigilance reporting obligations, and links to preventive and corrective actions. Additionally, manufacturers must actively engage with patients and the public to gather feedback on device usability and instructions for use.

The new PMS requirements also mandate that manufacturers consider publicly available safety data on competitor devices if these could impact the safety of their products.

When comparing devices, manufacturers should not only consider those with the same intended purpose but also those used in similar environments.

Manufacturers must now inform the UK Responsible Person (UKRP) and UK Approved Body (UKAB), where applicable, of any preventive or corrective actions taken to address risks or non-conformities that could impact device performance or safety.

UKABs are responsible for reviewing Corrective and Preventive Actions (CAPAs) and assessing their impact on certification.

In addition, manufacturers must provide a Post-market Surveillance Report (PMSR) or a Periodic Safety Update Report (PSUR) to the MHRA within three working days upon request.

A PMSR must be prepared within three years of a device being first placed on the market or put into service, or if the device is already in use, within three years of the regulation coming into force. PMSRs must be updated at least every three years.

Manufacturers of Class IIa devices and above are also required to prepare a PSUR, which should provide a summary of PMS activities, data collection, and analysis, without duplicating all PMS reports.

The MHRA has published guidelines on the format and structure of PSURs to ensure standardization.

In addition, manufacturers must provide a Post-market Surveillance Report (PMSR) or a Periodic Safety Update Report (PSUR) to the MHRA within three working days upon request. A PMSR must be prepared within three years of a device being first placed on the market or put into service, or if the device is already in use, within three years of the regulation coming into force.

PMSRs must be updated at least every three years. Manufacturers of Class IIa devices and above are also required to prepare a PSUR, which should provide a summary of PMS activities, data collection, and analysis, without duplicating all PMS reports. The MHRA has published guidelines on the format and structure of PSURs to ensure standardization.

Manufacturers, UKRPs, or Authorized Representatives must notify the MHRA about incidents and Field Safety Corrective Actions (FSCAs) that meet reporting criteria. If an incident occurs due to the combined use of separate devices or accessories made by different manufacturers, each manufacturer must submit a report to the MHRA.

The regulation also specifies strict deadlines for reporting incidents. Serious public health threats must be reported within two calendar days, while incidents involving death or unanticipated serious deterioration must be reported within ten calendar days.

If the deterioration was anticipated but still serious, the deadline is fifteen calendar days. All reports must be submitted through the MHRA’s MORE portal, as no other submission routes are accepted.

To enhance traceability, PMS incident reports must now include a Unique Device Identifier (UDI), where available. Manufacturers are responsible for investigating all reported incidents and implementing necessary corrective actions.

If the MHRA requests further information during an investigation, the manufacturer must provide it within three UK working days. While there is no statutory deadline for submitting final incident reports, they should be provided as soon as possible.

Furthermore, if an investigation involves destructive testing of a device, manufacturers must notify the MHRA before proceeding.

Manufacturers must have systems in place to detect trends throughout the PMS period. If they identify a significant increase in the number or severity of incidents compared to pre-determined thresholds, and if these incidents could adversely impact the device’s risk assessment, a trend report must be submitted to the MHRA.

Methods for determining statistical significance, as well as reporting guidelines for trend reports, are available through the MHRA’s MORE portal. Trend reports must be submitted for incidents that are individually reportable, as well as for those that do not meet individual reporting criteria.

Conclusion

The 2024 No. 1368 regulations introduce stricter PMS obligations for medical device manufacturers, emphasizing proactive risk management, structured reporting, and extended surveillance periods.

The new rules require manufacturers to take a more systematic approach to incident detection, risk mitigation, and compliance reporting. Adhering to these new requirements is crucial for maintaining regulatory compliance and ensuring continued market access in Great Britain.

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