The EU AI Act is poised to be a catalyst for innovation in MedTech, according to our latest survey.
Nearly nine out of ten (86%) respondents said they expect the AI Act to positively influence their organisation’s innovation in medical device technology.
We polled close to 200 professionals from the MedTech sector at our 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, our 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. Other notable hurdles include changing existing processes (29%), training (15%), and the cost of compliance (11%).
Brian McElligott, our Head of AI, commented: "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.
Michaela 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."
Read more about our survey findings on Irish Legal News or the Law Society of Ireland Gazette.
