Legal analysis - European legislative proposal draft AI act and MDR/IVDR
In April 2021 the European Commission released a regulation proposal, referred to as the AI Act, aimed at the safe and efficient development, implementation, and use of artificial intelligence (AI) in all market sectors. The Dutch Ministry of Health, Welfare and Sport (VWS) commissioned Hooghiemstra & Partners and Axon Lawyers to analyze the AI Act and any potential overlap between the act and the already-in-effect Medical Device Regulation (MDR) and the soon-to-be in effect In-vitro Diagnostic Medical Device Regulation (IVDR).
This report outlines the overlap and potential inconsistencies between the AI Act, as it was originally proposed, and the above mentioned legislation, identifies the problems this may lead to and proposes possible solutions. The authors of the report agree with the European Commission that AI in healthcare should be properly regulated but doubt whether the act is the right solution. The findings in this report focus on the need for further clarification of the definitions and on the scope mentioned in the act, in order to avoid ambiguities and any double burden placed on the healthcare sector.
VWS closely reviewed this report and used parts of it to formulate a VWS-wide position concerning the AI Act. The findings in this report, along with a broader collection of responses to the act, have been used in negotiations with the European Commission and in discussions over a compromise text. Since the commissioning of this report, there have been changes proposed to the act and these have been made available to the public in a compromise text. The main changes in the compromise text have been in regards to refinement of the definitions and further clarification of the scope of the act (with regard to MDR and IVDR). Negotiations with other member states are still ongoing and feedback from the healthcare sector will continue to be included in these talks.