Medical technology industry perspective on the final AI Act

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.

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.