Experts Seek Relief from the EU AI Act for the Medtech Industryh2>
During the 2025 European Digital Technology and Software conference in Rotterdam, Netherlands, a panel of experts expressed significant concerns regarding the recently enacted b>EU Artificial Intelligence (AI) Actb>. They argued that the legislation imposes substantial burdens on new medtech products, potentially preventing developers from entering the EU market.p>
The discussion highlighted how the complexities of the AI Act, in conjunction with other EU regulations, create challenges for medtech developers. Some experts are optimistic that the upcoming b>Digital Omnibusb>, expected to be presented later this month, may alleviate some of these regulatory pressures on AI-enabled healthcare products.p>
Market Uncertainty and Developer Challengesh3>
b>Alexander Olbrechtsb>, director of digital health at MedTech Europe, emphasized the need for AI regulation to be more manageable and predictable. He lamented the recent legal hurdles that have led to market uncertainties for product developers and investors alike. This lack of clarity regarding regulatory interpretations has pushed many startups to seek opportunities in the United States and Eastern markets.p>
“That’s a pity for our citizens,” Olbrechts noted. “If it’s not generated in your own region, your citizens will have later access to new life-saving and quality-of-life increasing technologies.” He argued that a single conformity assessment by a notified body familiar with the sector is essential for industry progress.p>
Calls for Repeal of the AI Acth3>
b>Leo Hovestadtb>, director of European governmental affairs at Elekta Netherlands, voiced a more pessimistic outlook. He warned that many promising AI medtech products may not reach the EU market due to the current legal landscape. Hovestadt proposed a straightforward solution: to repeal the AI Act as it applies to medtech products.p>
“The MDR is a very mature regulation,” he stated. “It even has the AI aspects in it. So get rid of the AI Act and just use the part about AI in the MDR, which is there, but most people cannot find that.”p>
Balancing Innovation and Well-Beingh3>
b>Maria Tresierrab>, a student researcher from New York University of Shanghai, offered a more optimistic perspective. She argued that the EU is adept at balancing innovation with societal well-being. Stressing the importance of keeping pace with AI’s rapid development, she advocated for regulatory measures that ensure equal benefits for all patients.p>
“The EU has to find this balance between regulating a new market disrupted by AI positively while considering the different market structures we are entering for health,” said Tresierra. She emphasized the need for legislation that supports equality in all forms, ensuring that healthcare data sets are representative and beneficial to public health.p>
Regulatory Landscape and Future Outlookh3>
When asked about the potential outcomes if the Commission does not implement significant changes in the Digital Omnibus, Tresierra maintained a hopeful stance. “We are still one of the most competitive pharmaceutical and health markets in the world,” she noted, adding that sufficient provisions exist to meet regulatory needs.p>
Olbrechts took a pragmatic view, mentioning that MedTech Europe had been collaborating with regulators to create FAQ documents aimed at clarifying the regulatory landscape. He also highlighted their advocacy for extending deadlines related to the AI Act’s implementation.p>
Hovestadt expressed belief that the deadlines set by the AI Act would likely be postponed as part of the Digital Omnibus, allowing manufacturers to better prepare, particularly given the current lack of notified bodies capable of conducting conformity assessments.p>
“I think we will delay it massively,” Hovestadt stated, emphasizing that without the necessary inspections, bringing products to market would be virtually impossible.p>
