After Brexit

While Great Britain is on the cusp of a major program of laying the foundations of its agile, post-EU medtech regulatory system, uncertainty persists over the future role and remit of local CABs.

The long-awaited extension of the UK MHRA’s standstill period for CE-marked devices circulating on the Great Britain market was announced in late April, offering new transition deadlines that go beyond the one extra year promised by the agency in fall 2022. Industry is studying the implications.

The Life Sciences Council has agreed to issue proposals on how the UK should recognize approvals granted by other trusted medical device regulatory jurisdictions. The need for speed in all matters relating to the UK’s sovereign medtech regulatory system has been stressed by the UK devices industry.

The UK government’s response to the MHRA consultation on future device regulation will be published very soon. So says the agency’s new health care access officer. But will there be enough time for companies to comply with it?

The One Agency initiative, patient safety, methods of funding and recruitment needs were pressing discussion themes during the MHRA’s April 2022 board meeting held in public.

In this Medtech Insight Q&A, two UCLA-backed study authors argue that the US FDA “has emerged as the global regulatory agency most successful in promoting access to novel medtech products, especially digitally enabled or software-driven ones.”

The Medicines and Medical Devices Act presses the UK to create regulations that make the market attractive for business. But striking the right balance in creating the new agency is crucial, said Phil Brown, director of regulation and compliance for the Association of British HealthTech Industries.

The Medicines and Medical Devices Act presses the UK to regulate in such a way that makes the market attractive for industry and investment. Medtech manufacturers insist the MHRA must strike the right balance as it brings its ‘plan for a new agency’ to life, said the ABHI’s Phil Brown, in the second of a two-part industry view of UK medtech’s regulatory future.

The MHRA is under pressure to deliver a new sovereign devices regulatory system in the tightest of timelines for the post-Brexit UK market. It has had no lack of support in this endeavor from system users, but industry is now keen to see the regulator deliver on its two-year plan issued in 2021, says the ABHI’s Phil Brown, in this first part of a two-part industry view of future UK needs.

Graeme Tunbridge is looking forward to a new career with notified body, BSI, after nearly two decades as a civil servant. But where does his departure leave the UK MHRA at a time of critical change?

Innovative device access pathways are on the agenda of both NICE and the MHRA, but the UK regulator’s new chief safety officer stresses that patient safety first and foremost will shape its work programs in the post-EU era.

The UK's medtech regulatory consultation has closed and the MHRA must now assess the views of stakeholders on the 465 questions designed to help shape the foundations of a future-proofed regulatory system. But time is tight, as speakers at the ABHI’s annual regulatory conference were at pains to stress.

The MHRA’s efforts to give the UK a nimble, responsive, innovation-facing medtech regulatory system earnt high marks from Bristows’ Alex Denoon, who assessed the opportunity at hand during the MedTech Summit.

The MHRA intends to drop around 300 roles as it faces a financial crunch after leaving the EU and other pressures.

IVD and healthtech industry representatives give their views on how the future UK medtech system can be shaped to be agile and responsive to patients’ needs, mindful that the regulator must deliver a standalone regulatory system and functional UKCA marking in less than two years.

The fragility of start-ups belies their value in medtech innovation, and they do not need unnecessary regulatory complications.