Report: Legal analysis European legislative proposal draft AI act and MDR/IVDR

In April 2021 the European Commission proposed a regulation aimed at the safe and efficient development, implementation and use of artificial intelligence (AI) in all market sectors, the so-called AI Act. Hooghiemstra & Partners and Axon Lawyers have made a legal analysis on request of the Dutch Ministry of Health, Welfare and Sport to compare the draft AI Act proposed by the European Commission with the Medical Device Regulation (MDR) that has already entered into force and soon also the In-vitro Diagnostic Medical Device Regulation (IVDR).
The report contains an analysis of the overlap and possible contradictions between the draft AI Act and the above mentioned legislation, identifies the problems that this may cause and suggests possible solutions. The report concludes that AI in healthcare must be properly regulated but doubts that the draft AI Act, as first proposed, can provide good guidance for the field. The findings of the report focus on the need for further clarification of the definitions and scope mentioned in the draft AI Act, in order to avoid ambiguities and double burdening of the field.
Read the report here.