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AI Act will drive medtech dynamism – survey

The EU AI Act is poised to be a catalyst for innovation in medtech, a new Mason Hayes & Curran (MHC) survey suggests.

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

The business law firm polled close to 200 professionals at its recent webinar, ‘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.

Michaela Herron (MHC head of life sciences) 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%) of respondents.

Hurdles

Other notable hurdles include changing existing processes (29%), training (15%), and the cost of compliance (11%).

Brian McElligott (head of AI law at MHC) 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%) 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.