Background

The MHRA published the new Post-Market Surveillance (PMS) regulation (SI 2024/1368) in December: HERE

The new PMS regulation introduces changes such as:

• revised timeframes to report serious incidents,
• a requirement to implement a PMS system that proactively gathers and assesses data about the devices on the market, and
• report significant increases in the frequency or severity of incidents involving a device, if the manufacturer considers that increase could have a significant adverse impact on the risk analysis.  

It comes into force starting 16 June 2025.

Which devices are impacted?

SI 2024/1368 applies to all devices placed on the market or put into service in Great Britain, including those that are CE Marked. This is noted in the legislation’s Explanatory Memorandum:

“5.3      The regulations will increase the scope of medical devices that must comply with the PMS requirements in GB. This will include CE marked devices, which are currently allowed onto the GB market under transition provisions within the UK MDR 2002 and, at the time of writing, are estimated to constitute 91% of the devices registered with the MHRA, based on the registration of new medical technology products. Extending the scope of the regulations to these devices will maintain parity between the requirements for manufacturers to report to the MHRA for both CE and UKCA marked devices…”

Note that the regulation cannot require manufacturers of CE marked devices to amend their CE technical documentation with information learned from the UK PMS report. It can only require manufacturers of UKCA marked devices to do this:

“5.3      …For CE marked devices, regulation 44ZE(4), which requires a manufacturer to ensure the data gathered through the PMS system are used to update the technical documentation, does not apply as this instrument cannot mandate that manufacturers update technical documentation as set out in EU law.”

However, the new PMS guidance notes that, while it cannot be legislatively mandated, the “MHRA expects manufacturers to apply the same principles to update technical documentation for CE-marked devices placed on the GB market”. I.e., manufacturers of CE Marked devices should comply with this element of SI 2024/1368 as well, or face potential challenges from the MHRA if/when inspected.

Overview of Guidance

The guidance is available: HERE

Below we provide examples of topics covered. Please review the entire guidance for comprehensive information.

Lifetime of a Device

The MHRA defines the lifetime of a device:

“The device lifetime runs from the time of manufacture/production date to the end of the period the manufacturer has validated the device will perform as intended, sometimes referred to as the expected service life (validated use duration – see Figure 1). This includes the device shelf life, if it has one.”

And provides examples of devices that may continue to be used past the manufacturer’s defined lifetime, into its ‘potential lifespan‘ of how long it ‘could reasonably remain in use‘.

• “An implant may reasonably be tested and validated to continue to perform as intended for 10 years, whereas management of clinical risks supports leaving the implant in place until it begins to show signs of failure. Gathering PMS information throughout the time the implant remains in use helps develop understanding of the implant’s long-term clinical functionality and ensures any unexpected late risks are picked up as quickly as possible.
• Large imaging systems installed in healthcare settings may in practice continue to be used, for economic and practical reasons, beyond the period of use for which they have been validated. Furthermore, maintenance and replacement of components can extend the life of the device. If safety or performance issues come to light from extended usage of such a system, information would need to be shared with other users to help avoid serious impact on patient care.
• A wheelchair or mobility scooter is typically used until it can no longer function or be repaired, especially in home setting. They may also be sold second hand a number of times.
• Laboratory analytical instrumentation (for use as IVD) is often used beyond its lifetime, provided it is properly maintained and regularly calibrated.”

Post-Market Surveillance (PMS) System Requirements

The MHRA introduces a requirement to implement a post-market surveillance system. See image below for a high-level overview.

The PMS Plan must, at minimum, specify the manufacturer’s: 

• objectives of the PMS system 
• processes to gather information (ensuring comprehensive real-world data obtained) 
• methods of data analysis 
• fulfillment of their vigilance reporting obligations 
• links to preventive and corrective action as part of a risk management process 

Manufacturers must review action taken against the PMS Plan at regular intervals, and document the review within a Post Market Surveillance Report (PMSR) / Periodic Safety Update Report (PSUR), as applicable.

Upon request, the most up-to-date report must be made available to the MHRA within 3 working days.

See image below for high-level overview of report time-frames.

Feedback from Users

Guidance is provided on the requirement to obtain “feedback from users including patient and public engagement (Regulation 44ZF(3)(a)(v))”, e.g.,

• obtaining feedback on usability of the device, and adequacy of the instructions for use which are provided, which is “particularly important for devices used by patients or members of the public with limited or no involvement from healthcare professionals”
• feedback should be solicited in the least burdensome way for users
• provides resources for further information and advice on undertaking patient and public engagement: Home – PEM Suite, Devices-PE QG.pdf (pemsuite.org), MTG Guide to Meaningful Patient Involvement)    

Field Safety Corrective Actions (FSCA)

If all of the following criteria apply, then a corrective action constitutes an FSCA:

• field: devices have already been made available for use (for example, entered the distribution chain to a separate distributor, importer, retailer, hospital, or provided directly to the end user)
• safety: there is a risk of death or serious deterioration in health 
• corrective action: any action taken to reduce or mitigate this risk for the devices 

Manufacturers must submit the proposed Field Safety Notice (FSN) to the MHRA prior to sharing it with customers, to allow the MHRA to provide advice on the FSCA implementation strategy and/or comments on the draft FSN. If you do not receive a response within 5 days of submitting to the MHRA, you should circulate the FSN to customers. Or, if the action is urgent, you can select the FSN after submitting it to the MHRA, without waiting the for the 5 day period to lapse.

The MHRA further provides the following templates and guidance for FSNs: guidance on effective field safety notices, FSN template, FSN template Q&A, FSN customer reply, FSN distributor / importer reply

Trend Reporting

The regulation newly introduces the requirement to have a system in place to detect trends and report if there is a statistical increase in the frequency or severity of incidents involving a device, if the manufacturer considers that increase could have a significant adverse impact on the risk analysis.

The MHRA links to additional guidance on how to establish if an increase is statistically significant: PD CEN ISO/TR 20416 Medical devices — Post-market surveillance for manufacturers, this historical Global Harmonisation Task Force (GHTF) document

And provides examples of reportable trends:

• “a significant increase in number of expected false positive or false negative results from a diagnostic test in comparison to the stated performance of the device in the instructions for use 
• a number of complaints are received involving devices supplied cracked and unusable due to damage caused in transit 
• a higher-than-expected number of complaints are received concerning over-infusion from an infusion pump with the same root cause 
• a significant number of complaints are received concerning failure of an implant, despite these occurring beyond the manufacturer’s specified lifetime of the device  
• a significant increase in the rate of strokes among patients implanted with a particular kind of carotid stent”

Trend reports must be submitted through the MORE portal.

UK PMS Procedure & Plan Templates

Further Reading

• How to Create a UK Manufacturer’s On-Line Reporting Environment (MORE) Account
• Vigilance Requirements Tool (List of Contacts, Forms, and more)
• Is There Benefit to UKCA Marking Early?
• Guide: Shelf Life, Expiration Date, Expected Lifetime/Useful Life, Service Life, Life Cycle
• Guide to Risk Management Concepts and Terminology
• MHRA Medical Device & IVD Registration Overview
• UK Responsible Person (UKRP) Overview