UK medical device reforms – direction of travel and an opportunity to get involved

The UK’s medical devices regime is undergoing an extensive reform process 2021 - see our blog post here) and the recent publication of regulations to improve post-market surveillance systems (see our blog post here). 

At a recent speech to techUK Health & Social Care, Laura Squire OBE, Chief Healthcare Quality and Access Officer, at the MHRA highlighted some of the forthcoming changes.
Dr Squire discussed the substantial amendments being put through, including the PMS changes mentioned above. Other points to note include:

• Measures to improve traceability such as unique identifiers and implant cards for patients.
• More proportionality to the risk level of products, with changes to the categorisation rules. The highest risk classification will include implantables, and we can expect software and in vitro diagnostics to attract higher risk classifications.
• in vitro diagnostics rules will largely mirror international standards but take a more pragmatic approach where possible.
• A greater degree of international reliance where products have been approved within comparable systems.
• Flexibility on the requirement to use UKCA marking, noting that adoption of UK Conformity Assessed (UKCA) has so far been slow. (Manufacturers of MDs and IVDs can currently use the UKCA marking process to access the GB market, either by self-certification for low-risk devices, or by conformity assessment and certification by an Approved Body designated by the MHRA as competent to assess medical devices.)

The MHRA is aware of the need for regulation to be proportionate, so that patients can access the care that they need. On software, where innovation is especially rapid, the intention is to take a “regulation light and guidance heavy” approach. Dr Squire also indicated that the MHRA is considering charging manufacturers for advice.

A number of these areas are currently open for consultation, focusing on the following areas:

• International reliance –The intention is to supplement UKCA marking with an extensive international reliance scheme to facilitate quicker market access. The list of comparable regulator countries will initially include Australia, Canada, the EU and the USA, with ongoing discussions aimed at adding Japan.
• UKCA marking - MDs must carry a UKCA marking to be placed on the GB market if they have undergone the UK conformity assessment process, where practical and appropriate.  The MHRA is seeking views on removing current marking requirements for MDs which undergo the current UKCA process, where this can be effectively replaced through new UDI requirements. 
• IVDs – IVDs will be classified in four risk classes in line with their level of risk, with each class having different requirements for the IVD to gain market access. The system differs somewhat from the EU system, with a view to controls being more risk proportionate. 
• Assimilated EU law – the proposed revocation of a number of EU laws as and when these are replaced by new UK legislation. 

This consultation remains open for input until 5th January 2025. 

We will monitor and report on updates on the medical device reform package, with further consultations expected on the expansion of digital labelling and the “health institution exemption” (which enables certain healthcare institutions to manufacture and use medical devices in limited circumstances without needing satisfy full regulatory requirements).

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