Experts look for relief from EU AI Act for medtech industry

ROTTERDAM, NETHERLANDS – A panel of experts raised concerns about the recently enacted EU Artificial Intelligence (AI) Act, which they said poses a significant burden on new medtech products and could keep some developers from entering the EU market.

The experts discussed how the legislation, and its interplay with other EU regulations, could be too burdensome for medtech developers during the closing plenary of the 2025 European Digital Technology and Software conference. Some of the experts were hopeful that the European Commission’s Digital Omnibus, which is expected to be presented later this month, will ease some of the regulatory burdens on AI-enabled healthcare products.

Alexander Olbrechts, director of digital health at MedTech Europe, said that AI regulation needs to be more manageable and predictable for the technology to be successfully adopted in Europe. He bemoaned recent legal and regulatory hurdles which have created uncertainties in the market for product developers and investors, not only regarding the interpretation of regulations, but also whether aspects of those regulations will apply to their products. As a result, he warned that many startups are going to the US and Eastern markets because there’s too much uncertainty in the European market.

“That's a pity for our citizens, because if it's not generated in your own region, it means that your citizens will have later access to new life-saving and quality-of-life increasing technologies,” said Olbrechts. “In order to fix that, we need that predictability and that equal certainty.

“For our industry, it’s necessary that we have one conformity assessment by a notified body that is familiar to our sector in a clear framework of time,” he added.

Leo Hovestadt, director of European governmental affairs at Elekta Netherlands, had a more pessimistic outlook, stating that many promising AI medtech products will not come to market in the EU due to the current legal environment. He said the difficulty in getting AI products to market and finding investors who will fund such products should be an alarm bell for industry stakeholders.

Despite his concerns, Hovestadt said there’s a simple solution: to repeal the AI Act as it applies to medtech products.

“The MDR is a very mature regulation,” he said. “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.”

Maria Tresierra, a student researcher from New York University of Shanghai, struck a more favorable view. She argued that the EU is good at striking a balance between innovation and societal well-being. In terms of competition, she argued that it is essential to keep pace with the rapid development of AI, while ensuring it benefits all patients.

“The EU has to find this balance between regulating a new market that is disrupted by AI in a positive way but keeping in mind that it is a different market structure that we are entering for health,” said Tresierra. “Secondly, I would keep pushing for the regulation in favor of equality in all senses, so equality within income, within gender or race… to make sure that while we are participating in the inventive processes in research health disparity setting.

“We need to be legislating in favor of the holistic population and ensuring that our data sets in healthcare are representative, ensuring that the benefits of AI outputs can actually contribute to greater public health,” she added.

Maarten ter Mors, an attendee and CTO of CREATE Regulatory Consultancy, asked the panelists what would happen if the Commission made no significant changes in its Digital Omnibus, which is expected to be presented later this month.

Tresierra said she doesn’t think the regulatory landscape is that hopeless and has faith that EU regulators are doing a good job of protecting consumers.

“We are still one of the most competitive pharmaceutical and health markets in the world, and I do think that in the case that everything stayed the same… There are enough provisions to [address the regulatory needs],” she said.

Olbrechts took a pragmatic approach, stating that even before the omnibus was proposed, Medtech Europe had been working with key regulators and other stakeholders to develop FAQ documents and find ways to provide more certainty to the industry. He also noted that the lobby group has advocated for a delay to the deadlines to implement the AI Act.

“I think the world would not end, and eventually, I think we would get there, but it will take a long time, and it will be a complex way forward to eventually get to [similar] points,” said Olbrechts. “Now with Digital Omnibus, it's hopefully one of the biggest tools to solve it.

“We have to continue the work that we have been doing in the past, and hopefully other opportunities will present themselves,” he added.

Hovestadt argued the deadlines in the AI Act will be significantly delayed as part of the Digital Omnibus, allowing manufacturers to catch up, especially given the lack of notified bodies that can conduct conformity assessments under the act.

“I think we will delay it massively,” said Hovestadt. “We don't have the notified bodies yet for the AI act, so it's [regulatorily] impossible to get your products onto the market because no one is going to inspect them.”

Experts look for relief from EU AI Act for medtech industry

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