In response to the European Parliament Plenary endorsement of the AI Act, MedTech Europe would like to present a medical technology industry perspective on the final agreed text of the AI Act.
We welcome the significant efforts made by the co-legislators to reduce unnecessary administrative complexities and legal uncertainties arising from the simultaneous application of multiple Union Harmonisation Legislation and encourage consistency across the relevant applicable rules for the medical
technology sector. We appreciate the difficulty of the task presented to lawmakers to provide for horizontal regulation on an emerging and complex technology such as artificial intelligence while providing for its safe and effective integration across the EU market. Co-legislators have made great strides to increasing clarity and consistency within the AI Act, including on rules on data and data governance, which we agree are further reflective of the technological realities of training and validation, or the revised approach taken by colegislators towards the exercise of human oversight, with requirements based on contextual realities rather than a one-size-fits-all requirement.
However, further clarity is still needed to ensure that the AI Act supports European technological innovation, and the wider integration of AI within and across European healthcare settings, ensuring timely delivery of trustworthy, safe and effective care and diagnosis, for the benefit of patients and healthcare systems.
Many existing AI solutions used today in national healthcare systems are integrated into medical technologies and regulated under the Medical Devices Regulation (MDR), and the In Vitro Diagnostic Medical Devices Regulation (IVDR) which each lay down comprehensive requirements for product design and development, as well as for clinical performance, patient safety and security protections. MDR/IVDR also regulate medical devices and in vitro diagnostic medical devices incorporating or qualifying as artificial intelligence-based software. Going forward, many such AI solutions will qualify as high-risk AI systems under the AI Act, and medical technology manufacturers will therefore need to ensure compliance with both the MDR/IVDR and
the corresponding requirements under the AI Act.