Earlier in October 2024, The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 ("Regulations") were laid before Parliament. The Regulations are the result of consultation by the MHRA on the future regulation of medical devices in Great Britain ("GB") following Brexit and, if enacted by Parliament, will amend the UK Medical Device Regulations 2002 ("UK MDR").
If your organisation is involved in post-market surveillance ("PMS") in GB, manufactures medical devices (including custom-made devices), acts as a clinical research organisation (CRO), distributes medical devices or is appointed as a 'UK responsible person', then you will need to be aware of the impact of the Regulations.
What impact will the Regulations have?
More robust standards for GB PMS systems:
The Regulations are intended to improve patient and public safety, and so the expected standards for PMS activities are heightened under the Regulations. In particular, the Regulations will require manufacturers to amend any current PMS systems which do not comply with the new rules, and to develop PMS plans. There is specific detail within the Regulations as to what PMS systems and plans must include.
Incidents, corrective actions and trends:
Manufacturers will need to put in place new and updated procedures to comply with GB requirements on reporting of, and dealing with, incidents, corrective actions and trends. This will require having robust processes in place for monitoring the safety and performance of devices, which may require closer cooperation with end-users, clinicians and distributors.
Closer alignment with the EU approach (but with differences):
The Regulations intend to upgrade the PMS requirements in GB to a similar standard to that required at an EU level (which the UK did not adopt post-Brexit). There are differences, however, and medical device manufacturers must assess their planned PMS activities specifically against the GB requirements and not assume that they are exactly the same as in the EU. Practically, this may mean that those manufacturers carrying out PMS in both GB and EU member states will be required to apply different systems to ensure compliance or, pragmatically, manufacturers could conduct a comparison of the differences and apply the most stringent requirement as the default (to the extent that that is possible). It is likely that most medical device companies are accustomed to operating under different regimes, especially if they are operating in other jurisdictions, such as the US under FDA regulation.
Some examples of the differences include:
Retention periods:
Under the new GB regime, PMS documentation will need to be retained for the longer of: (a) the 'lifetime' (which is different from the 'shelf-life') of the last device of that model that is put into service or placed on the market, or (b) 15 years for implantable devices or 10 years for other devices. This was the wording included in an earlier draft of the Regulations, and some commentators thought this was perhaps a drafting error as the wording was similar to, but subtly different from, the EU approach (e.g. 10 or 15 years after the last device has been placed on the market); however, the wording has remained unchanged, so manufacturers should ensure they are not caught out by this difference.
Exception to reporting serious incidents:
The EU 'exception' to reporting side effects that are expected and clearly detailed in the product information and technical documentation does not appear in the Regulations. Therefore, these expected side effects may need to be reported under the GB regime.
When will the changes apply?
The Regulations are not yet legally binding and need to go through the Parliamentary process. However, the UK Government's website suggests that the changes could become law as early as Summer 2025.
Is there any further guidance?
The UK Government's website also confirms that guidance will be published to support manufacturers with implementation and compliance, but only once the Parliamentary process has been concluded.
MFMac's Healthcare and Life Sciences team can assist with any queries you may have on the new Regulations and how your organisation's existing or future agreements with study-sites, distributors, CROs and/or clinicians may be affected. Please contact Valerie Armstrong-Surgenor, Partner or Melissa Hall, Senior Associate.