MHRA floats overhaul of medical device regulation in public consultation

Regulatory NewsRegulatory News | 20 September 2021 |  By 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advanced its effort to set up a post-Brexit regulatory environment by initiating a consultation on medical device regulation and establishing a work program for software and artificial intelligence (AI).
With the Brexit transition period ending before the European Union’s Medical Device Regulation took effect, the UK is free to set out its own plans for oversight of the industry. The government, informed by the findings of the independent Cumberlege Review, has already laid the groundwork for a new approach to regulation in the Medicines and Medical Devices Act 2021. MHRA now plans to use the powers to amend how medical devices are regulated in the UK.
The consultation document released to gather feedback on the plans has 17 chapters and covers all aspects of how medical devices are regulated in the UK. Some chapters have more than 10 questions for the industry and other stakeholders.
One chapter addresses the classification of medical devices. The UK currently assigns medical devices to Class I, IIa, IIb or III based on their risk. MHRA is proposing to retain the basic structure but move certain types of devices to new risk categories because, “The existing classification rules are, in some respects, out of step with best international practice - particularly for implantable medical devices such as surgical mesh and software as a medical device.”
The changes proposed by MHRA, such as assigning active implantable devices and surgical mesh to Class III, are intended “to reflect changes in technology and better account for how medical devices are used - including the level of invasiveness and potential toxicity of certain devices.” MHRA wants to know if industry and other stakeholders agree with its proposed changes.
In the chapter on routes to market, MHRA proposes several new ways to get medical devices to UK patients. MHRA is considering allowing companies to use approvals from other countries or Medical Device Single Audit Program (MDSAP) certificates to bring products to the UK market.
“Manufacturers entering through these alternative routes could apply for an abridged assessment with an Approved Body. Introducing alternative routes to market could have a number of benefits for example in enhancing the supply of devices to the UK market and in supporting MHRA’s ambition for medical devices regulation to become globally harmonized,” MHRA wrote in the consultation.
The chapter on routes to market also features a proposed fast-track medtech pathway. Devices that meet the criteria, for example because they target a rare disease or are “game changers,” could come to market before going through the conformity assessment process. MHRA framed the pathway and an associated innovation hub as a way to alleviate “cost and capacity obstacles” to patient access to medical devices.
MHRA is accepting feedback on the medical device consultation until 25 November. The feedback will inform the development of a new regulatory regime that is scheduled to take effect in July 2023 “with appropriate transitional arrangements.” MHRA selected the date to align with when it will stop accepting CE-marked medical devices.
One of the chapters addresses the transitional arrangements. MHRA is considering five options that it could adopt alone or in combination. One option is to allow medical devices placed on the market with a valid CE mark before 1 July 2023 to remain available until the certificate expires “subject to a light touch assessment that those devices meet the necessary regulatory standard.” Alternatively, MHRA may only allow devices with a UKCA certificate to stay on the market after 1 July 2023.
MHRA published details of the consultation alongside an update on its plans for the regulation of software and AI as a medical device. The agency has created 11 work packages designed to provide a regulatory framework that protects patients, provides clear requirements for industry and aligns with the work of other agencies to prevent the duplication of activities.
Eight of the work packages cover reforms across the software as a medical device life cycle. Through the postmarket work package, MHRA will aim to implement a surveillance system and use real-world evidence. MHRA has created similar objectives for the other reform-focused work packages.
The three remaining work packages consider “further challenges that AI can pose to medical device regulation” and are designed to operate in tandem with the other eight work packages. MHRA plans to address the rigor, interpretability and adaptivity of AI through the three work packages. Specific objectives include making use of “existing and broadly accepted frameworks” to ensure the safety and effectiveness of AI as a medical device.
MHRA will work on the packages through to the summer of 2023. The agency plans to share a closer look at the work packages, the changes they may bring and timelines for the reforms in the coming months.
MHRA Consultation, AI Notice


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