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.
