MedTech Europe’s reaction to the EU Council’s General Approach on the AI Act

MedTech Europe recognises the amendments made by the EU Council aimed at clarifying the responsibilities under the draft legislation, such as the definition of AI systems and Chapter II requirements. Further steps are needed to ensure this regulation aligns well with sectoral requirements, such as the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

The MDR and IVDR set out stringent requirements to ensure that actors in the healthcare ecosystem can benefit from technologies with high level of protection of health and safety before the technologies are placed on the market. By adding another regulatory layer, the AI Act risks creating legal uncertainty and unnecessary regulatory burdens on providers of AI-enabled medical technologies because of potential duplicate or contradicting requirements. Therefore, ensuring sectoral alignment is vital for European patients and healthcare professionals alike who either rely on AI-enabled medical technology now, or will do so in the future, as it will provide them with the opportunity to enjoy the fullest potential of healthcare they need and deserve. If the sectoral alignment remains unaddressed, resulting issues such as the fragmented conformity assessment procedures, risk creating new and unwarranted bottlenecks, adversely affecting the delivery of AI-enabled medical technologies to patients and healthcare professionals.

MedTech Europe would like to share its reaction on three key changes brought to the proposed legislation by the EU Council. We encourage the incoming Swedish Council Presidency to consider our recommendations on these amendments and maintain a flexible position with the regards the upcoming inter-institutional negotiations.