Chris Whitehouse, medical technology policy and regulation expert at White House Communications and president of the Professional Association of Urologygives its opinion on the consultation published by the MHRA on the regulation of medical devices in the United Kingdom.
In the wee hours of the night, Sunday 26e June, the British government finally published its answer Medicines and Healthcare products Regulatory Agency (MHRA) 2021 consultation on its post-Brexit regulatory framework for medical devices in the UK.
This long-awaited response had been delayed for months, due to political and internal scheduling issues. But, its release comes at a very appropriate time, with the government’s MedTech Directorate due to release its medical device strategy in July and, crucially, with industry players losing patience and pushing for clarity on timelines. compliance with the new UKCA and the existing CE. markings – with the current deadline of July 2023 fast approaching.
For months there have been growing fears that the government is simply advancing what appears to be an unrealistic compliance date. But the 155-page response demonstrates that the MHRA listened to the many comments provided by nearly 900 respondents.
In short, the UK regulator will allow three- and five-year transitions for CE-marked diagnostic devices and equipment. The conditions for keeping these devices on the market after the entry into force of the regulation will depend on key factors, such as the nature of the device and the rules under which the existing conformity mark was awarded. The reform package will apply to medical devices such as catheters, hearing aids, CT scanners and X-ray machines, as well as new technologies such as smartphone apps, software and artificial intelligence.
As part of these reforms, the government claims to have placed patient safety and medical device innovation at the heart of its future regulatory framework. Throughout the response to the consultation, the government defends the ability of the MHRA to protect public health by enabling access to a high quality supply of safe and effective medical devices through appropriate regulatory oversight.
Innovation and globalization are also fundamental principles at the heart of the government’s response, which has underlined its intention 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 has been encouraged to introduce new market access routes that promote international trade, advance its ambition of global harmonization of medical device regulations, avoid duplication of existing frameworks, to minimize the burden on industry, to promote international collaboration with attentive regulators, while maintaining regulatory oversight.
Generally speaking, there are no surprises in the publication of this article [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 the statutory powers of regulation in this sector from the EU to the United Kingdom.
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 liability, device traceability, post-market surveillance, clinical evaluations and performance studies are just a few areas where industry will seek greater clarity and engagement with parliamentarians and government officials. The devil will undoubtedly be in the details, and we can expect a series of statutory instruments and statutory guidance in the coming months to advance the future framework of arrangements, hopefully alongside the strategy now imminent and also very delayed for the new MedTech. Directorate of the Department of Health and Social Action.
Medtech players must continue to engage with officials and regulators to ensure that the regulatory system and strategy actually achieves what government ministers have claimed as their goals – enhanced patient safety, better clinical outcomes and a thriving and innovative medical device economy.
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