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. 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’. These are public or private organisations that an EU member-state (and the UK) authorises to approve products before they are put on the market. The best known in the UK is the British Standards Institution (BSI). The notified bodies are struggling to equip themselves with the necessary skills and capacity to cope with the workload arising from the new MDR. Manufacturers are now incurring higher costs and longer timelines to have devices certified or recertified. This is not just because they need to repeat testing, but also because the notified bodies can now take over a year to review the associated technical documentation, when it used to take a few months.
Manufacturers will have to go through the UKCA processes on top of the updated European process
The UK is in a particularly challenging position as a result of Brexit. Had the MDR been implemented as planned in 2020, the UK would have adopted the new European regulations before the end of the Brexit transition period. But because MDR implementation was delayed due to COVID-19, the UK has maintained the old MDD until a new domestic regulatory framework is put in place. As an interim position, the UK is allowing medical devices tagged with the EU’s CE mark to be used until June 2023. After that, all medical devices sold in the UK will need to have been reviewed by UK approved bodies and given a UK Conformity Assessed marking (UKCA). There is not currently any mutual recognition of the necessary medical device testing between the EU and UK, so manufacturers selling on both markets will need to go through the testing process twice.
A window for opportunity
These challenges also create a window of opportunity for the UK to alter its approach to medical device regulation. The UK has four potential options. It could:
Continue with a unique UK regulatory framework for medical devices, requiring the recertification of all medical devices by June 2023. However, the UK market may be considered too small for some manufacturers to justify the costs, especially if such recertification requires a different type of testing because regulations are different in the UK from elsewhere.
Pursue option one but attempt to supplement it with strengthened and new mutual recognition agreements with some other regulatory jurisdictions (Canada, Australia, New Zealand and Singapore are sometimes mentioned). This approach would be more global in nature and could potentially reduce the compliance burden for medical device companies. But it would place some constraints on the UK’s regulatory autonomy, as it would probably require some harmonisation of approach. It would also probably be slow to implement and require renegotiation when the UK or another country updates its own regulations.
Continue to allow EU CE marked medical devices to be marketed in the UK for a much longer period of time and de-prioritise the implementation of its own regime. The UK could try to negotiate access to the new European database on medical devices (EUDAMED) to assist in this, or require manufactures to use a similar UK database. This approach would offer greatest continuity for businesses and ensure ongoing alignment between Great Britain and Northern Ireland (where Northern Ireland’s special status under the Northern Ireland protocol means CE marking still applies). But it would also see the UK inherit the challenges arising from messy MDR implementation in the EU, without the means to influence EU attempts to address them.
Open up its market by unilaterally allowing medical devices that are in use in other trusted jurisdictions such as the US, EU, Canada and Australia to be sold in the UK, subject to a registration requirement. This would allow UK patients to access innovative medical devices that are already on the market in other countries, but there is a downside: the UK should not expect reciprocity from these foreign regulators – especially the USA. This would give foreign manufacturers an advantage over UK ones since a US company would have easy access to the UK market but UK companies would not enjoy similar easy access to the US market. In addition, unilateral recognition of foreign certification would mean other countries determined the rules used to ensure medical devices are safe and effective, leaving the UK as a rule taker – and not just from the EU.
Of course, the divide between the different options is not clear cut in practice. An amalgamation of aspects of the four approaches listed is possible. However, the issues associated with a new UK approach to regulating medical devices illustrate the trade-offs the UK will need to navigate.
Opportunities to diverge from EU rules and approaches, and deliver better outcomes for companies, consumers and patients do exist. However, with its relatively small market size, the UK will struggle to break free entirely from the regulatory pull of larger economies – particularly when it comes to highly regulated products. In the case of medical devices, British patients are more likely to benefit if the UK systematically embraces its position as an Australian-style rule taker, and free-rides on the regulatory innovation and capacity of others. UK companies might also benefit from such an approach, as their device development could be focused on the requirements of large export markets (perhaps especially the US) in the knowledge that doing so would also ensure access to their home market.
Need further support?
Join us on 23rd September for our CE Marking Bitesize Session to learn about the impact of Brexit on labelling requirements.
Check revised guidance on UK Gov website
Contact our International Trade Team at exportbritain@gmchamber.co.uk for further support and advice.
Source: Adapted from Centre for European Reform