Medical Device Reform – Two important updates from the MHRA

MHRA publishes roadmap for regulation of medical software and artificial intelligence (AI) in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a roadmap for the ‘Software and AI as a Medical Device Change Programme’, which sets out how the MHRA will develop the regulation of medical software and AI in the UK.

The roadmap for the programme describes 11 workgroups and the themes allocated to different aspects of the regulatory regime and the intended deliverables. Eight of the workgroups are allocated to different aspects of the regulatory regime. Three of the workgroups consider the specific regulatory challenges posed by medical devices that employ AI over and above classically programmed software.

The aim of the Change Programme is to deliver broad steps to a regulatory framework that provides a high degree of protection for patients and the public, but also ensures that the UK is recognised in the global market as a home of responsible innovation for medical device software.

Focus of the Software and AI as a Medical Device change programme

The focus of the Software and AI as a Medical Device Change Programme include:

• The requirements for software and AI as a medical device to provide assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public.
• The requirements for manufacturers are clear, supported by guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for example, through the designation of standards.
• Friction is removed from the market to align with key partners domestically, remove duplication, and combine requirements. Internationally, the MHRA work with other regulators through the International Medical Device Regulators Forum to strengthen international convergence and consensus on software and AI products.

The roadmap can be found here. The first deliverables from the workgroups are expected by the end of the year and we will be following developments in this important area and publishing further updates as the Change Programme evolves.

MHRA declares a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024

The MHRA has declared that it will be delaying the implementation of the future Medical Device Regulations, with an aim of bringing new regulations into force by July 2024. The government recognises that the future Medical Device Regulations are a substantial reform of the current framework, and in an attempt to support system readiness and minimise the risk of supply disruptions for UK patients, it has delayed implementing the new Medical Device Regulations by a year.

The MHRA had consulted on the future regulation of medical devices in the United Kingdom, with the government originally publishing its response to the consultation with its intended changes to the legislative framework in June 2022. For reference, our article on this consultation can be found here.  

Transitional arrangements

As a consequence of the delay, there will now be an extension to the recognition of CE marked medical devices placed on the Great Britain (England, Scotland and Wales (separate arrangements exist for Northern Ireland post Brexit under the Northern Ireland Protocol)) market. Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023.

The Government intends to introduce legislation by “Spring 2023” that will bring into force transitional arrangements and post-market surveillance requirements for medical devices with an intention that from July 2024, transitional arrangements will apply to CE and UKCA marked devices placed on the Great Britain market.

The Government will further amend the relevant guidance on regulating medical devices in the UK to reflect the extended timelines for implementing the future Medical Device Regulations.

The MHRA announcement can be found here.

HOW WE CAN HELP

Our team of regulatory and commercial experts regularly advise clients on the medical device regulatory framework, including commercialisation, manufacturing and distribution arrangements. Should you wish to discuss any issues relating to medical device regulation, please contact Vincent Buscemi or Louise Brennan.