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A major update to UK Medical Device Regulations 2002 was recently laid before parliament, starting the process for a 2024 update to UK MDR by the Medicines and Healthcare products Regulatory Agency (MHRA) which should come into force Summer 2025.
Free Post Market Surveillance Review
What’s new?
Apart from some updates to definitions and clarifications including what constitutes a “working day”, the big change is the introduction of Post Market Surveillance (PMS) requirements for medical devices sold in the UK. This reflects the outcomes of a consultation held by the UK Medical Device regulator – the MHRA – in 2021, which pointed towards close alignment with European legislation. However, while the requirements are similar to the EU MDR’s PMS requirements, they are not identical.
What is Post Market Surveillance?
Post Market Surveillance or PMS is a series of processes (and associated documents) that medical device manufacturers (working with local representatives, importers and distributors) must implement and maintain in order to ensure patient safety and monitor the devices effectiveness after release. This is an important part of medical device risk management and is achieved by gathering post-market data, analysing it and making improvements to their device.
Which Medical Devices do these new requirements apply to?
These requirements apply to all medical devices placed on the UK market (i.e. including any given away as free samples); however, the requirements vary for each device classification, for example below is a list of report writing requirements.
| Risk Classification | Report Type | Frequency | Must be provided to a Notified Body? |
|---|---|---|---|
|
Class I |
Post Market Surveillance Report |
Every 3 years |
No |
|
Class IIa |
Periodic Safety Update Report |
Every 2 years |
Yes |
|
Class IIb |
|||
|
Class III |
Annual |
What do I need to do?
Once the new regulations are approved by the UK Parliament (which is expected to happen this year) you’ll have six months to comply. In order to continue to sell your medical devices into the UK market from Summer 2025, you’ll need to make sure you have met the new requirements which include the following:
PMS System
Currently, the Post Market Surveillance system required in the UK should be used to systematically review post-production data and ensure that appropriate corrections actions can be identified and implemented.
Under the proposed UK MDR 2024, the requirements on the PMS are much more proactive and dynamic. Your PMS system must be used throughout the lifetime of the device and the data collected by its processes should feed directly into:
- Design Inputs
- Labelling and IFUs
- Clinical Evaluations
- Risk Analyses
- Other updates to your technical documentation.
Documents
| UK MDR 2002 | UK MDR 2024 |
|---|---|
|
PMS Plan |
PMS Plan |
|
Post Market Clinical Follow-up Report |
Post Market Clinical Follow-up Report |
|
PMS Report (PMSR)* |
|
|
Periodic Safety Update Report (PSUR)* |
*Either PSMR or PSUR are applicable depending on your device’s risk classification – you only need to do one or the other.
PMS Plan
PMSR/PSUR
As a summary activity, you’ll now need to produce a report, which lists the results of all of your PMS activities. In essence, this is a collection of the analyses of the data you’ve collected, along with a summary of any incidents and corrective or preventive actions. Depending on the risk status of your product, this will either be a Post Market Surveillance Report (for low risk devices) or a Periodic Safety Update Report (for everything else). The two are similar, but the PSUR requires extra details, including a reasonable estimate of the size of the population in the UK using your product, along with actual number of devices put onto the UK market in the reporting period.
A PSMR must be created within three years of your product being on the market and must be updated at least every three years. A PSUR, however, may have a more frequent need to review, depending on your exact product. Don’t forget to include the timelines for these reports in your quality management system planning!
Incident Reporting
Another change relates to the reporting timelines for serious incidents. These are the times within which a serious incident must be reported to the MHRA after you have discovered it.
| Incident Type | UK MDR 2002 | UK MDR 2024 |
|---|---|---|
|
Serious Public Health Threat |
2 Days |
2 Days |
|
Death or Unanticipated Deterioration in Health |
10 Days |
10 Days |
|
Other Reportable Incidents |
30 Days |
15 Days |
Is this the same as the European PMS requirements?
While this update does bring the UK MDR into much closer alignment with its European equivalent (even referencing the EU MDR requirements directly in a number of places), there are some details which differ that you may need to consider if you already have a PMS system under EU MDR in place.
Highlights of which include:
- Your UK PMS plan specifically must record the projected lifetime of the device (this should already be found elsewhere in your EU MDR Technical Documentation)
- Your PMS Report/PSUR must record data such as usage and patient demographics that is specific to the UK, separate from EU territories.
- The requirement to get feedback through patient and public engagement (the equivalent in the EU is from Annex III of EU MDR – “information, including feedback and complaints, provided by users, distributors and importers”, which lacks the requirement specifically for public engagement).
- UK-specific requirements, such as reporting to the UK regulator – the MHRA – and engagement with your UK Approved Body (if you have one) and your UK Responsible Person (which you must have if your company is outside the UK and you sell a Medical Device in the UK).
What about IVDs?
Summary
If you’re selling, or plan to start selling your medical device product into the UK, then it’s important to consider the impact of these potential new regulations. They could be in force much sooner than you think.
If you need help with making sure your regulatory approach is up to date, we can help to make sure you’re always on the right track.
