The document outlines the strategies that the Medicine and Healthcare products Regulatory Agency (MHRA) has implemented, and will implement, in order to effectively regulate AI medical products (AIaMED).
United Kingdom – MHRA: Impact of AI on the regulation of medical products
Anno 2024
The document is divided into three parts: the first is dedicated to the role of the MHRA as a regulator of products containing AI; the second focuses on the MHRA as an organization that must make time-sensitive decisions; the third addresses the MHRA as an organization that must make evidence-based decisions.
Part I – The MHRA as a regulator of AI products
According to the agency, like all medical devices, AIaMED (AI as a Medical Device) must comply with the Medical Devices Regulations 2002 (MDR). This regulation has been continually amended over the years with a dual purpose: to respond to the needs arising from new technological discoveries and to move toward international regulatory alignment to facilitate exchange in the global market.
The current Medical Devices Regulations use a risk-based classification system, where Class I includes devices with low intrinsic risk, and Class III those with the highest. The higher the risk class, the more stringent the required controls. In upcoming reforms, this system will continue to apply; however, in order to better protect users and patients, certain AI products currently classified as low-risk (and therefore placed on the market without independent conformity assessment) will be reclassified into higher risk categories.
The agency has stated that it is "particularly mindful of the need to adopt a proportionate approach which takes account of the unique challenges of these types of products" in order to "avoid constraining innovation, where this can be done safely."
The document also presents several initiatives the MHRA will implement over the next year to improve the regulation of AI products.
Part II - The MHRA as a public service organization delivering time-crucial decisions
According to the MHRA, the use of artificial intelligence tools will also impact the organization and management of the agency itself, with positive effects throughout the medical device sector. In fact, more effective regulatory services will lead to faster access to medical products for patients in the United Kingdom. This, in turn, will allow the National Health Service (NHS) to focus its skilled workforce on priority activities that require advanced expertise.
To achieve this, the agency has expressed its readiness to develop and implement generative AI tools capable of assisting in writing documents, analyzing data, and providing suggestions and feedback, in order to help professionals work more efficiently in terms of time and resources.
From a regulatory standpoint, the agency has added several strategic themes to its 12-month technology roadmap, including: innovation, eradication of legacy systems and cybersecurity; and all the elements considered essential for the optimal use of AI in the healthcare and medical device sectors.
Part III - The MHRA as an organization that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties
Since 2020, the agency has been actively working on two fronts: encouraging pharmaceutical companies to adopt AI for pharmacovigilance, and optimizing its own systems through the use of this technology.
To better understand how to implement AI within its organization and how to promote its use across the industry, the MHRA has joined the Council for International Organizations of Medical Sciences (CIOMS).
In pursuing these goals, the MHRA follows the so-called “Pro-Innovation Approach” to AI regulation, which is based on five key principles: safety, security, and robustness; appropriate transparency and explainability; fairness; accountability and governance; contestability and redress.
The alignment with these principles is considered essential, as there is a shared intent to use these emerging tools with foresight and precision, ensuring that they are effectively leveraged in the interest of public health.
The full text of the document is available at the following link and in the download box.
Maria Vittoria Izzi
Pubblicato il: Martedì, 30 Aprile 2024 - Ultima modifica: Lunedì, 01 Settembre 2025
