The proposed European AI Act and its impact on the medical technology industry

Posted on 04.11.2021

Medical technologies powered by Artificial Intelligence can save lives and resources, and can help address the shortage of workforce in the healthcare sector by freeing healthcare professionals to engage in more human centric tasks. For AI in medical technology to reach its full potential, the appropriate legal and regulatory environment needs to be created. Such new regulatory measures need to address the issue of availability of quality data, existing organisational and financial challenges, as well as trust and skills among citizens, patients and healthcare professionals.

The European Commission’s proposed AI Act aims to ensure that AI is safe, and to stimulate the uptake of trustworthy AI in the EU economy. With the recent Medical Device and In-Vitro Diagnostics Regulations in place, MedTech Europe calls for alignment of the AI legislation’s requirements to ensure consistent and clear rules in support of the availability of AI-enabled medical technologies in the EU. MedTech Europe recently communicated its views in the October Issue of the European Parliament Magazine.

Please contact Michael Strübin, Director Digital Health, for further information.