MedTech Europe has called for the urgent clarification of a proposed artificial intelligence regulation because it uses an overly broad definition and is misaligned with existing regulatory frameworks. The European Commission outlined its plans to regulate AI, including medical devices and in vitro diagnostics that feature the technology, earlier this year. Under the proposal, the European Union would require high-risk AI systems to "comply with certain mandatory requirements" before coming to market. The Commission acknowledged a risk of overlap with existing regulations but envisioned the framework complementing requirements such as the Medical Devices Regulation. However, MedTech Europe contends the proposal falls short of that vision.

This paper address the challenges at the European level that impede the deployment of AI in healthcare and recommends specific policy actions to make healthcare better and safer, improve access and outcomes, empower patients and citizens with information, and make healthcare delivery more efficient. MedTech Europe and its members are committed to being trusted and collaborative partners in policy discussions on the responsible application of AI in healthcare.