BRUSSELS—The European Union is advancing artificial intelligence (AI) regulations that could impact medical device and diagnostic companies around the world. Through the policy, the EU plans to impose additional requirements on the use of AI in medical technology and issue fines for noncompliance that could total billions of dollars.
In a document setting out its plans, the European Commission states high-risk AI systems should only be placed on the EU market "if they comply with certain mandatory requirements" that ensure they do not pose unacceptable risks to important public interests. Medical devices and in vitro diagnostics are on a long list of products that could be classed as high risk.
The proposal acknowledges the risk of overlaps with other regulations and the potential to impose unnecessary burdens. Citing medical devices as an area in which overlaps may occur, the EU says the existing conformity assessment procedures will be used to check the proposed AI requirements.
Yiannos Tolias, a lawyer at the Commission’s health group, set out the need for AI requirements in addition to the existing Medical Device Regulation at an event held before the publication of the plans.
"The new horizontal AI proposal would come to complement or to stand next to the MDR," Tolias says. "An AI medical device...would be now more secure, in the sense that it will be also complying with the MDR obligations and in addition those aspects of AI that could be creating some worries and some concerns would be handled by the new AI regulations. So, the two would be ensuring that the system is secure and trustworthy and so on."
Large penalties await companies that fail to comply with the EU requirements on AI. The EU plans to issue fines of up to €30 million ($36 million) or, if the offender is a company, 6 percent of its total worldwide annual turnover for infringing the rules.