天美影院

1. Why we set up聽AI聽Airlock

As the medical device regulator for UK health and social care, the Medicines and Healthcare products Regulatory Agency (MHRA) holds a central role in patient safety. We are currently reforming the medical device regulations and supporting regulatory guidance for Software as a Medical Device (SaMD), which includes Artificial Intelligence as a Medical Device (AIaMD) products. These reforms build on a well-established regulatory system of legislation, guidance and standards to address known challenges and align with other regulatory jurisdictions around the world.

Along with this regulatory system update, we have seen a marked increase in innovative devices entering the UK market, particularly聽AIaMD聽and digital technologies using聽AI, which may be on the borderline of the scope of medical device regulations. Such products have the potential to revolutionise the healthcare landscape, maintain the UK as a home of cutting-edge research and provide improved ways to address patient and public needs. This potential brings novel challenges, shifts in known risks and safety concerns. The聽MHRA聽is seeking to balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure regulation does not present undue barriers to innovation.

Many of the known risks of聽SaMD/AIaMD聽products are identified and mitigated through existing regulatory requirements and processes such as Clinical Investigations and Post Market Surveillance. Our聽existing publications聽and further planned guidance documents outlined in the聽Software and聽AI聽as a Medical Device Change Programme聽provide further assistance to manufacturers. The pace of innovation continues to accelerate and the balance of rules-based versus principles-based regulation of聽AI聽is an ongoing topic across all sectors of society and around the world. To regulate聽AIaMD聽effectively and efficiently, increased collaboration and more proactive and agile ways of working are required, to help us find solutions to many unanswered questions.

2. Collaborating with partners

Team AB:聽launched in February 2024, Team AB brings together expertise from Approved Bodies to increase consistency of interpretation of UK medical device regulatory requirements. We are delighted to collaborate with Team AB on the聽AI聽Airlock project to uncover and navigate medical device regulatory challenges for聽AIaMD. We will use our collective regulatory knowledge to inform and standardise policy positions in this rapidly evolving area.

The聽NHS:聽the聽AI聽Airlock project will work closely with the Department of Health and Social Care (DHSC), and the聽NHS聽AI聽team, to provide connections and expertise with our healthcare system. Many聽AIaMD聽products are deployed via聽NHS聽infrastructure making聽NHS聽England and the health services in the devolved nations crucial to regulatory discussions such as deployment and post market surveillance.

3. Project outputs

The objective of聽AI聽Airlock is to identify regulatory challenges to聽AIaMD聽and work collaboratively to understand and potentially mitigate any risks that are uncovered. Relevant stakeholders and the product providers will be able to use the聽AI聽Airlock product reports to share knowledge and findings to assist with further funding or assessment activities.

Whilst guarantee of regulatory conformity is not the objective of the AI Airlock project, involvement in this project will benefit manufacturers on their regulatory journey. The聽MHRA聽also engages academic expertise to assess the multi-partner approach to the use of regulatory sandboxes and its impact on the innovation landscape. Finally, extension and additional funding, potential changes to medical device regulations and additional guidance documents will be considered for further sandboxes looking beyond聽AIaMD.

4. Webinar

Watch our webinar in July 2024 for more detail on the pilot programme launch.