Treat AI Act as part of EU ‘regulatory lasagna’ for devices, expert says

ROTTERDAM, NETHERLANDS — In addition to meeting the requirements of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), Erik Vollebregt, a partner at Axon Lawyers, said that manufacturers must also consider the recently enacted EU Artificial Intelligence (AI) Act as part of their overall strategy. While there are some uncertainties about conforming to the new law, he said stakeholders need to address it as a part of the overall regulatory strategy.

The AI Act was a major topic at the 2025 European Digital Health Technology and Software conference, where Vollebregt was among several speakers who discussed the legislation and its implications for the medtech industry. He and other experts also emphasized that stakeholders should read the Blue Guide, which details the EU’s product rules.

“[It’s] very important that you realize that the AI Act in relation to devices and IVDs is part of the regulatory lasagna,” said Vollebregt. “[Also], reading the Blue Guide is one of the best investments that you can do in your foundational knowledge in the field of AI and medical devices regulation ever.”

Vollebregt noted that the guide may be updated over the next few years as the European Commission considers changes and advised stakeholders to keep an eye on it.

There are several issues that Vollebregt is concerned with regarding the AI Act. He said that there are inconsistencies in key terms defined in the MDR, IVDR, and AI Act. As examples, he noted that while regulations surrounding CE markings typically use terms such as "manufacturer" and "end user," the AI Act uses the terms "provider" and "deployer" instead.

“It's very nice that they say, ‘Oh yeah, you can write technical documentation that covers both the MDR and the AI aspects of your medical device, but in practice, it’s really difficult to deal with if you have differently defined terms,” said Vollebregt. “You will basically always need to refer to defined terms as, ‘Now I am using this defined term as defined in the MDR, and now I am using it as defined in the AI Act.’”

Similarly, Vollebregt is concerned about unclear timelines, certain obligations under the AI Act for market participants, as well as concurrent obligations such as incident reporting and post-market surveillance requirements.

"You need to [not only] integrate your technical documentation, which exists both under the AI Act and the MDR, IVDR, but also your quality system, which is also problematic, because we have a quality system under the AI Act as well, ... [and] it's completely different,” said Vollebregt. “There are so many of these friction points.”

In addition to taking into consideration MDR, IVDR, and the AI Act, Vollebregt said manufacturers may also need to take into consideration the General Data Protection Regulation (GDPR), battery regulations, Restriction of Hazardous Substances (RoHS), Waste of Electrical and Electronic Equipment (WEEE), and national-level legislation.

“You need to keep in mind that the AI Act on the one hand, and MDR and IVDR on the other have really different goals, different objectives,” said Vollebregt. “The AI Act really focuses on transparency, data, quality and risk management, some of which actually overlap with criteria from medical devices and IVDs, but the orientation is different.”

For example, he emphasized that a medical device manufacturer with AI capabilities cannot just consider the medical device risk management of their product, but also the AI risk management.

Vollebregt also stated that addressing data is critical, as MDR, IVDR, and the AI Act all address the issue in their legislation. While the AI Act doesn’t address clinical data, manufacturers must evaluate how it intersects with MDR and IVDR.

Despite the concerns about the AI Act, Vollebregt said there may be some positive changes in the future to help alleviate the problems. He noted that he has been working as an external expert with the Commission to help them develop a targeted revision to improve the legislation.

“The Commission is keenly aware that for the medical devices industry, the AI act integration is one of the biggest problems at the moment, together with batteries [regulation],” said Vollebregt.

He added that the Commission is working on a digital omnibus, which could hold positive surprises for the industry, and urged stakeholders to stay tuned.

There is also concern that notified bodies have not yet been established to review products under the AI Act. However, Vollebregt said discussions have been held about potentially assigning an additional code to MDR and IVDR notified bodies, which could enable them to integrate the evaluation. If a solution is not found, European medtech companies may find themselves in the same situation they were in a few years ago, when there weren’t enough notified bodies to handle MDR and IVDR compliance.

Treat AI Act as part of EU ‘regulatory lasagna’ for devices, expert says

Related topics

Recommended content

Welcome to the new RAPS Digital Experience