Insight
Medical devices and the limits of UK regulatory autonomy by Sam Lowe and Derek Hill, 5 August 2021
Medical devices illustrate the limited scope for post-Brexit UK divergence from EU rules, and the trade-offs the UK must face. In his negotiations with the EU, Boris Johnson prioritised the UK’s ability to set its own rules and regulations (at least in respect of Great Britain). Yet more than five years after the UK voted to leave the EU, Johnson’s government is still struggling to articulate its vision for what it wants the UK to do differently from the EU and, more importantly, why. Medical device regulation provides an instructive example of both the opportunities now open to the UK, but also the constraints it will find itself under. Medical devices are technologies that help diagnose or treat patients, or prevent illness without the use of drugs. They include everything from MRI scanners, hip implants and scalpel blades to smartphone apps that treat depression. The EU is currently struggling to implement a wide-ranging change in how medical devices are regulated – from the 1993 Medical Device Directive (MDD) to the 2017 Medical Device Regulation (MDR). Phased introduction of the MDR was due to be completed by May 2020, but was extended until this year due to COVID-19 pressures. This new regulatory framework is designed to ensure more thorough testing of devices before they can be used on patients, and more rigorous monitoring of performance of devices once on the market. The MDR’s implementation, however, has not gone smoothly. There is an argument for UK divergence from the EU’s rules for these devices. Many of the devices already on the market in the EU and UK now require recertification. This recertification does not just mean repeating the same tests that were previously passed, such as for electrical safety and biocompatibility. For many devices, MDR compliance requires performing more thorough testing on patients (which can cost millions of pounds per device) than was required when the device was originally put on the market. At the same time there is a lack of clarity on how novel devices – like those containing artificial intelligence algorithms – should be tested. Unlike for medicines, Europe does not have a central regulatory agency for medical devices. Instead the process of checking whether devices can be given the medical device CE mark falls to ‘notified bodies’. CER INSIGHT: Medical devices and the limits of UK regulatory autonomy 5 August 2021
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