MedTech Europe Response to the Inception Impact Assessment on the Proposal for a Legal Act with Requirements for Artificial Intelligence

This document is in response to the public consultation on the roadmap for artificial intelligence (“AI”) by DG CNECT, Unit A2, and addresses directly the Inception impact assessment document Ares(2020)3896535 for the Proposal for a legal act of the European Parliament and the Council laying down requirements for Artificial Intelligence. MedTech Europe recently provided input to the public consultation on the White paper on AI and we have been following with keen interest the developments in the area of Sectoral Considerations for AI by the HLEG AI (we participated as an expert in the Healthcare focused workshops, organised by the group), as well as the work on the Liability implications of AI). We appreciate the opportunity to provide input to this conversation as well, bringing our specific healthcare expertise and perspective, and are open to answer any questions.

In this document we:
1) Outline the specificities of AI in medical technologies & relevant existing sectoral legislation;
2) Give some background on the risk management in medtech;
3) Discuss the possible scope of the legal initiative;
4) Provide our opinion on the pros and cons of the different policy options suggested in the impact assessment from a medical technology perspective;
5) Offer a conclusion.