World leading? The future arrangements for medical device regulation – Med-Tech Innovation
compliance rules and law regulation policy on virtual screen, documents with checkbox lists
In the small hours of the night, on Sunday 26th June, the UK government finally released its response to the Medicines and Healthcare products Regulatory Agency (MHRA’s) 2021 consultation on its post-Brexit medical devices regulatory framework in the United Kingdom.
This much anticipated response had been held up for months, due to political and internal timing issues. But, its release comes at a very appropriate moment, with the government’s MedTech Directorate due to release its strategy for medical devices in July and, crucially, with industry players losing patience and pushing for clarity on the compliance timings with the new UKCA and existing CE markings – with the existing July 2023 deadline fast approaching.
For months, concern has been mounting that the government would simply push ahead with what seemed an unrealistic compliance date. But the 155-page response demonstrates that the MHRA has listened to the extensive feedback provided by nearly 900 respondents.
In short, the UK regulator will allow three- and five-year transitions for CE-marked devices and diagnostic equipment. The conditions for these devices remaining on the market after the regulation comes into force will depend on key factors, such as the nature of the device and the rules under which the existing conformity mark was given. The package of reforms will apply to medical devices such as catheters, hearing aids, CT, and x-ray machines, as well as new technologies such as smartphone apps, software and artificial intelligence.
Within the scope of these reforms, the government claims to have put patient safety and medical device innovation at the heart of its future regulatory framework. Throughout the consultation response, the government champions the MHRA’s ability to safeguard public health by enabling access to a high-quality supply of safe and effective medical devices through appropriate regulatory oversight.
Innovation and globalisation are also fundamental principles at the heart of the government’s response, having outlined that it intends to make the UK the best place in the World to develop and introduce innovative medical devices. The primary objective in this case will be to improve support for innovation in medical devices, as well as access to medical devices.
To achieve this ambition, the MHRA have been encouraged to introduce new routes to market which promote international trade, drive forward its ambition for the global harmonisation of medical devices regulations, avoid duplication of existing frameworks, minimise burden on industry, promote international collaboration with like-minded regulators, whilst at the same time, maintaining regulatory oversight.
Broadly speaking, there is no surprise in the publication of this paper [although its arrival online at around 2am on a Sunday morning raised eyebrows]. It is long overdue and is the inevitable consequence of the implementation of the provisions of the Medicines and Medical Devices Act 2021, which repatriated to the UK from the EU the statutory powers of regulation in this sector.
Yet, while the government’s response answers some key questions on the minds of industry players, it also opens Pandora’s box for new requirements and deadlines. For example, manufacturer accountability, device traceability, post-market surveillance, clinical evaluations and performance studies are just a handful of areas where the industry will be seeking further clarity and engagement with parliamentarians and government officials. The devil will undoubtedly be in the detail, and we can expect a raft of statutory instruments and statutory guidance in the coming months to drive forward the future devices framework, alongside, hopefully, the now imminent and also much delayed, strategy for the new MedTech Directorate of the Department of Health and Social Care.
Those in the medtech sector need to continue to engage with officials and regulators to ensure that the regulatory system and strategy actually delivers what government ministers have claimed as their objectives – strengthened patient safety, improved clinical outcomes and a thriving and innovative medical devices economy.
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