Giving British medical device manufacturers and importers the flexibility to use either the CE mark or UKCA mark for an extended period is a hugely welcome step, insists a regulatory specialist

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell, believes the announcement to confirm timescales for the acceptance of CE marked medical devices on the Great Britain market is “an extremely positive move during a complex, challenging time of Brexit transition for many.”

CE marking on goods approved by the Department for Business and Trade will now be indefinitely recognised on the UK market. However, the Medicines and Healthcare products Regulatory Agency (MHRA) has moved quickly to state that medical devices and in vitro diagnostics devices will remain under current legislation and will stay on their UK-based regulatory trajectory.

The MHRA – which was given the power to design, consult upon and implement a new legislative framework for medical devices in 2021 – is keen to remind medical device companies of the deadlines which are specific to medical devices and are different to the wider CE mark extension.

Instead of being indefinite, the acceptance of CE marked medical devices in Great Britain has been extended until 30 June 2028 for general medical devices compliant with the EU medical devices directive; and for general medical devices, including custom-made devices, compliant with the EU medical devices regulation, the deadline will be 30 June 2030.

Elaine – recently awarded the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University – said: “Clarification from the MHRA on this extension has resulted from close consultation with the medical devices industry – talking to the people who know the issues best.

“The extension also represents acknowledgement that more time was needed to prepare for the transition to UK Approved Bodies from European Notified Bodies sparked by Brexit and the transition to new European and UK legislation.

“A further significant aspect of that requirement is UK patients facing the prospect of losing access to vital products as part of a potential supply disruption risk.

“It is also worth noting that core aspects of the future regime are expected to be transitioned to ahead of 2028 – as early as July 2025 in fact – giving further clarity.”

She added: “The MHRA have called it ‘a proportionate, phased approach to the implementation of the future regulatory framework which supports system readiness’ and that seems like a sensible road to go down.”

Ahead of that, the MHRA will be carefully introducing strengthened Post-Market Surveillance requirement (PMS) legislation this year, which has been published on the World Trade Organization (WTO) portal. The amendments seek to introduce clearer, risk proportionate PMS requirements.

Elaine said: “Expected to apply from mid-2024, this will help to improve the ability of both the manufacturer and the MHRA to identify issues with medical devices placed onto the Great Britain market and where necessary, take appropriate action to safeguard public health. This is to be welcomed too.”

InnoScot Health offers a skilled team of regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.

With more than 20 years’ experience in medical device development, Elaine Gemmell is a certified ISO 13485/ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.