MHRA Unveils AI Airlock to Regulate AI Medical Devices

MHRA unveils AI Airlock to assist the MHRA and addressing the challenges associated with the regulation of standalone AIaMD by initially identifying and supporting 4 to 6 virtual or real-world projects through simulation. AI Airlock is the new regulatory sandbox for AI as a Medical Device (AlaMD).

The regulatory sandbox model is an industry-recognized approach to tackling new regulatory issues across industries. AI Airlock will build on this robust approach to deliver what is needed to make these devices work in the real world.

The regulatory sandbox of MHRA is ever-evolving in the domain of health technology. NHS is on track to become a leading health technology provider by 2030 by investing in cutting-edge AI solutions.

As the UK’s leading medical device regulator, the MHRA plays an important role in the safety of patients. As part of its ongoing reform of the medical device regulatory landscape, MHRA unveils AI Airlock will be supporting regulatory guidance and reforming the regulatory framework for software as a medical device (SaMD), including AIaMD products. The MHRA’s core role is to ensure the safety of patients, which is why they are reforming the existing regulatory framework for medical devices. This reform builds on an established regulatory system of laws, guidelines, and standards to tackle well-known issues and align with global regulatory jurisdictions.

 “We are currently seeing a marked increase in innovative AIaMD products entering the UK market that have the potential to revolutionize the healthcare landscape and provide improved ways to address patient and public needs.” Stated by the Head of Software and AI, of MHRA, Dr Paul Campbell.

Further Dr Paul Campbell also added, “As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation.”

The new procedure of MHRA unveils AI Airlock will allow the health authority to assess several regulatory challenges for these devices that are utilized for direct clinical use within the NHS.

The results of the government, regulator, and industry collaboration will feed into future AI Airlock initiatives and shape future UK and global guidance for AIaMD. The launch of AI Airlock to regulate AI medical services includes how the MHRA collaborates with UK Approved Bodies on UKCA marking and with respected regulatory partners on global recognition of medical devices.

The challenge for the MHRA is to find the right balance between proper oversight to ensure patient safety and the flexibility needed to respond quickly to the specific challenges caused by these products so that regulation does not stand in the way of innovation.

To ensure effective and efficient regulation of AIaMD, enhanced collaboration, and proactive and agile working methods are needed to help answer the many questions that remain unanswered.

Many of the well-known risks associated with SaMD/ AIaMD products have already been identified and addressed through regulatory requirements and practices, including Clinical Investigations and post-market (PMS) surveillance. The rate of innovation is increasing, and the balance between rules-based vs. principles-based AI regulation is a crucial issue across all industries and the globe.

AI Airlock’s goal is to find regulatory issues with AIaMD and to work together to identify and potentially reduce any identified risks. Stakeholders and product providers will have the opportunity to use product reports from AI Airlock to share information and findings to support further study, research or evaluation activities. While guarantee of regulatory compliance is not the project’s goal, participation in the project will help manufacturers along the regulatory journey. The MHRA unveils AI Airlock also plans to bring in academic experts to evaluate the multidisciplinary approach to regulatory sandboxes, and how it impacts the innovation landscape.