Michaela Herron

The business law firm polled close to 200 professionals from the medtech sector at its recent webinar titled “What the AI Act Means for Medical Devices”. The findings come as the new regulations approach final legislative approval, with the Act expected to come into force in August.

Nearly nine out of 10 (86 per cent) respondents said they expect the AI Act to positively influence their organisation’s innovation in medical device technology.

Michaela Herron, head of life sciences at Mason Hayes & Curran, said: “The AI Act is an additional regulatory regime for AI medical device manufacturers to grapple with. However, the optimism of our findings reflects the potential of these new rules to drive advancements in AI applications, fostering a more dynamic industry environment.

“By establishing clear regulatory frameworks, these laws not only enhance safety and build trust, but could also support the adoption of cutting-edge AI technologies in the medical field.”

Despite this optimism, the survey also highlighted several significant challenges that organisations face in adapting to the new regulations.

Understanding high-risk AI classification emerged as the top challenge, cited by almost half (45 per cent) of respondents. Other notable hurdles include changing existing processes (29 per cent), training (15 per cent), and the cost of compliance (11 per cent).

Brian McElligott, head of AI Law at Mason Hayes & Curran, said: “The AI Act sets forth specific requirements for high-risk AI systems which only partially align with existing medical device requirements. Standards are being developed in parallel with the Act to guide compliance, which are expected to be of some assistance in closing this gap.

“The 2027 compliance deadline for high-risk AI systems in the medical device space is expected to be challenging based on the complexity of the law and the overlap with the Medical Device Regulation, so early engagement with regulatory processes and standardisation efforts is essential.”

The survey revealed that more than half (54 per cent) of organisations are already preparing for compliance with the high-risk requirements of the AI Act. Additionally, 58% are planning to increase investment in compliance because of the new regulations.

Ms Herron added: “Investment in compliance is a strategic priority for many organisations, but integrating the requirements of the AI Act with existing regulatory frameworks can present additional challenges.

“Companies should start with an inventory of their AI systems, conduct gap assessments, and consider what technical and contractual changes may be required. It is critical to develop a comprehensive roadmap for compliance and to keep pace with evolving standards.

“Our goal is to help clients navigate these complexities and turn regulatory compliance into a competitive advantage.”