William Lee, head of policy at the British Healthcare Trades Association (BHTA), outlines three key questions for the Government on behalf of the healthcare manufacturing sector to deliver the future of medical device regulation in the UK, following confusion over CE mark recognition in the UK.
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UK flag with Big Ben and House of Parliament in the background
Earlier this month, the Department for Business and Trade announced that British manufacturers will be permitted to indefinitely use the European CE mark for product safety accreditation, despite plans to adopt the UKCA as a British alternative. While this was welcomed by businesses across the country, the Medicines and Healthcare products Regulatory Agency (MHRA) soon clarified that the extension does not apply to medical device manufacturing.
Will the Government provide regulatory certainty for industry?
While we don’t doubt the intentions of the MHRA to develop a world-leading regulatory regime, the reality for businesses is that since Brexit, one of the few consistencies in plans for the transition from the CE mark has been near-constant change; visions and practicalities have shifted many times, while previous deadlines have been missed and re-set. It’s no wonder businesses have been left questioning the value and credibility of the regulatory transition. It’s great to see that MHRA have now put in place a timeline for delivery, but it’s no comfort that adjustments continue.
It’s increasingly apparent that this is a point of frustration for both industry and regulators and has an underlying impact on all current and future investment decisions. Indeed, a recent survey of BHTA members found that almost a third of suppliers are focusing on other international markets where such certainty exists. Collaboration between industry, policymakers, healthcare professionals and patients is simply essential to achieve the shared goal of advancing healthcare excellence, and clarity over timelines, scope, and the business impact of the UKCA mark has never been so vital. The MHRA has launched a timely consultation in this area, and we look forward to hearing the outcome.
How will the UKCA mark for medical devices and healthcare products be recognised by the public?
The MHRA’s vision for a leading regulatory regime is both admirable and welcome but a separate and standalone accreditation system for just a handful of sectors - healthcare manufacturing and construction, most notably – begs the question of how consumers and the public will view and understand regulatory standards. Medical device manufacturers face the same overheads, costs and regulatory burdens as other sectors now relieved from new UKCA requirements, and this fragmented approach by different Government departments has undoubtedly led to wider uncertainty among businesses and the public.
Will the UK be ready to implement a new regulatory regime?
Amid these changes, businesses are confronting a longstanding issue: the capacity and resource of notified bodies available to accredit new devices. Until recently, the UK had just four assessment bodies. MHRA appears to have designated two more in August this year, bringing the UK total to six approved bodies, compared to the nearly 40 designated bodies in the EU.
With ongoing bottlenecks, products can face undue delays of months and years before gaining approval for the UK market. While it is essential, we have access to safe medical devices, we must also ensure whatever regime in place fosters innovation as new products constantly evolve to improve standards, effectiveness, and quality of life for patients. Likewise, we could face a gulf where well-established and proven technologies accredited in the EU are not available on the UK market. The Government should look to expand the capacity at these bodies with the upmost importance if UKCA is to be world leading.
