Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
Like Dorothy striding over shiny yellow bricks on the Yellow Brick Road, the MHRA is continuing to advance along its regulatory roadmap, launched on January 9, 2024. In particular, three policy developments have recently been announced, which we summarize below.
AI Airlock. On May 9, 2024, the MHRA launched the AI Airlock. Within the context of the MHRA’s strategic approach to AI, this is a pilot project aimed at identifying and addressing the regulatory challenges posed by artificial intelligence (AI) medical devices (AIaMD). Though it is based on regulatory sandbox models, it differs by bringing together expertise from across the UK healthcare landscape, including the National Health Service AI Lab, UK Approved Bodies, the Department of Health and Social Care, and the MHRA itself.
Through this collaborative approach, challenging areas such as generating postmarket surveillance data for AIaMD and understanding the implications of automated decision-making within clinical workflows will be addressed. The project will open for applications after a webinar on July 23, 2024, and will be a crucial step in designing the future regulatory framework for AIaMD in the UK.
International recognition of medical devices. On May 21, 2024, the MHRA published a statement of policy intent indicating that new routes into the UK market for medical devices would be made available on the basis of international recognition. This policy approach is aligned with the MHRA’s approach for medicinal products under the international recognition procedure introduced on January 1, 2024. At present, the UK already recognizes CE certification obtained by device manufacturers in the European Union (EU). In addition to the EU, the other proposed comparable regulator countries for the future regime are Australia, Canada, and the United States.
Further information and conditions on eligibility, classification, and reliance are outlined in the policy document, which also makes clear that manufacturers of medical devices would still have the option to use the UKCA marking for the Great Britain market. The final version of this proposed framework is intended to come into force at the same time as the future core regulations in Q4 2025.
Consultation on common specification requirements for in vitro diagnostic devices. On May 21, 2024, the MHRA launched a consultation seeking the views of stakeholders regarding the inclusion of common specification requirements as a means for certain high-risk devices to demonstrate conformity with applicable essential requirements in the new UK regime. The MHRA’s proposal is that these common specifications should be consistent with requirements for class D IVDs in the EU’s In Vitro Diagnostics Regulation (2017/746) (IVDR). Common specification requirements build upon the “common technical specifications” of the existing UK framework. However, if a risk-based classification system akin to that in the IVDR is adopted in the new UK regime (as is proposed), the common technical specifications referenced in the current UK legislation, which relies on a predetermined list-based classification system, will become redundant.
Depending on the outcome of the consultation, the common specifications for class D IVDs could be consistent with the General Safety and Performance Requirements in the IVDR. Indeed, the government proposal recognizes that “consistency with EU regulations in this area would help support the availability and favourability of the Great Britain market.”
Stakeholder discussions on the future core regulations, guidance on software as a medical device, and the entry into force of the post-market surveillance regulations are expected later in 2024. To help the MHRA reach its own Emerald City of a reformed UK medical device regulation, industry stakeholders should continue to engage with the MRHA, which appears to be taking a transparent and purposeful approach to its work over this transitional period, as seen in its blog posts.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
