The UK Medicines and Health Products Regulatory Agency (MHRA) has stepped up efforts to build a post-Brexit regulatory environment by launching 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 EU’s medical device regulation comes into effect, the UK is free to set its own plans for monitoring the industry. The government, informed by the findings of the Cumberlege Independent Review, has already laid the groundwork for a new approach to regulation in the Drugs and Medical Devices Act 2021. The MHRA now plans to use the powers to change the regulation of medical devices in the UK. .

The consultation paper released to gather feedback on the plans consists of 17 chapters and covers all aspects of medical device regulation in the UK. Some chapters contain more than 10 questions for industry and other stakeholders.

A chapter deals with the classification of medical devices. The UK currently assigns medical devices to Class I, IIa, IIb or III based on their risk. The MHRA proposes to keep the basic structure but to move certain types of devices to new risk categories because “the existing classification rules are, in some respects, out of step with international best practices – in particular for implantable medical devices. such as surgical mesh and software as a medical device.

The changes proposed by the MHRA, such as assigning active implantable devices and surgical mesh to Class III, are intended to “reflect technological changes and better reflect the way medical devices are used, including the level of invasiveness and potential toxicity of certain devices ”. The MHRA wants to know if the industry and other stakeholders agree with the proposed changes.

In the chapter on Market Pathways, the MHRA suggests several new ways to get medical devices to UK patients. The MHRA is considering allowing companies to use approvals from other countries or certificates from the Unique Medical Device Audit Program (MDSAP) to introduce products to the UK market.

“Manufacturers entering through these alternative routes could request an abbreviated assessment from an approved body. Introducing alternative pathways to the market could have a number of benefits, for example by improving the supply of devices in the UK market and supporting the ambition of the MHRA to harmonize the regulation of medical devices in the UK. ‘global scale,’ the MHRA wrote in the consultation.

The chapter on routes to market also presents a proposal for a fast track for medical technologies. Devices that meet the criteria, for example because they target a rare disease or are “game-changers”, could hit the market before going through the conformity assessment process. The MHRA has defined the path and an associated innovation hub as a means of reducing “cost and capacity barriers” to patient access to medical devices.

The MHRA is accepting comments on the medical device consultation until November 25. The comments will inform the development of a new regulatory regime that is expected to come into effect in July 2023 “with appropriate transitional arrangements.” The MHRA has chosen a date to align with the date it will stop accepting CE marked medical devices.

One of the chapters deals with transitional arrangements. The 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 CE mark valid before July 1, 2023 to remain available until the expiration of the certificate “subject to a slight assessment indicating that these devices meet the regulatory standard. necessary “. Alternatively, the MHRA can only allow devices with a UKCA certificate to remain on the market after July 1, 2023.

The MHRA has released details of the consultation along with an update on its plans to regulate software and AI as a medical device. The agency 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 avoid duplication of activities.

Eight of the work packages cover software reforms as a lifecycle of a medical device. Through the post-market work package, the MHRA will aim to implement a surveillance system and use real-world evidence. The MHRA has created similar objectives for the other reform-oriented work packages.

The remaining three work packages examine “other challenges AI can pose to medical device regulation” and are designed to work in tandem with the other eight work packages. The MHRA plans to address the rigor, interpretability and adaptability of AI across the three work packages. Specific objectives include the use of “existing and widely accepted frameworks” to ensure the safety and effectiveness of AI as a medical device.

The MHRA will work on the packages until the summer of 2023. The agency plans to share a more in-depth review of the work packages, changes they can make, and timetables for reforms in the coming months.

MHRA consultation, AI Reviews