InLaw: Medtech regulatory challenges posed by diverging UK and EU regulations

Medtech innovators face an increasingly complex regulatory framework following Brexit. Ian Manners, a regulatory partner at UK law firm Ashfords, looks at the challenges posed by diverging UK and EU regulations

The UK government’s response to the consultation on future regulation of medical devices (MDs) in the United Kingdom published in June 2022, began by stating that the UK’s decision to leave the EU has provided a great opportunity to build our own regulatory regime.

In the response, Sajid Javid, as secretary of state for health and social care at the time, celebrated the track record of innovation-friendly medtech regulation established by the UK’s relevant regulator, the Medicines and Healthcare products Regulatory Authority (MHRA).

In addition, he set out a strategy for the future regulation of MDs. Among its aims were:

• Making the UK a focus for innovation – the best place to develop and introduce innovative MDs (which can include a growing range of software)
• Addressing health inequalities
• Ensuring proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards
• Setting world leading standards – building the UKCA mark as a global exemplar

Bold and admirable aims, yet just over a year on, medtech organisations have the task of navigating a diverging regulatory framework when seeking to develop and offer MDs and in vitro diagnostic medical devices (IVDs) in the UK and Europe. The dual certification process (UKCA marking for UK and CE marking for Europe) for firms keen to access both markets inevitably leads to an increase in the time and cost required for testing and approval, as there remains a woefully low number of approved bodies which can issue the UKCA.

Despite the UK government’s stated aims, it has pushed back the launch of mandatory UKCA marking for MDs and is currently looking to apply the core aspects of the future regime to apply from only 1 July 2025, but with some continued acceptance of CE mark for certain approved devices until 2030. To compare, UKCA marked devices may not be sold in the EU unless they are also CE marked.

This all may create a false impression that the EU is therefore the best place for medtech organisations to develop, certify and market their products, but look further and things are not much easier there. Whereas the UK is keen to allow MD developers to simplify processes, such as self-certification for certain classes of product, thus alleviating some of the pressure on the few approved bodies who can issue the UKCA mark, the European Commission remains keen on a fuller conformity assessment testing regime via its network of notified bodies in order to achieve the CE mark. This is particularly notable with the divergent UK and EU regulatory regimes around Software as a Medical Device (SaMD), where the EU has operated a stricter standard since 2021. Looking forward to the impact of SaMD and Artificial Intelligence (AI) in the sector, the MHRA’s Software and AI as a Medical Device Change Programme sets out a plan to regulate medical software and AI in the UK.

Medtech organisations that operate in the EU have on multiple occasions pushed for reform – a recent example being the open letter dated 14 September 2023, to EU Commissioner for Health, Stella Kyriakides. This called for changes in the EU regulatory framework, including an overhaul of the CE marking regime and even demanded that the EU be brought into the Medical Device Single Audit Program, which certifies MDs for compliance with the regulatory frameworks for Australia, Brazil, Canada, Japan, and the United States.

The technological solutions offered by MDs have never been more needed, whether that be to alleviate waiting times, improve diagnostic accuracy or in the treatment of conditions at home. The UK government must ensure that medtech organisations continue to consider the UK as a key market they can’t ignore. While the current approach will ideally speed up and simplify the regulatory approval process, the inevitable reality is that there is hardly any space for true divergence for medtech firms, given the global focus of the market.

The UK’s regulatory regime must have significant commonality with the existing global regulatory framework to minimise disruption and thus, when delivering its policy objectives, it must maintain an ongoing global focus. Straying too far from the European and worldwide frameworks creates additional issues that will act as a disincentive to investment and could lead to the UK medtech market becoming marginalised.