Regulatory
The AI Act establishes a legal framework across the EU, including stringent requirements for some applications and an outright ban on others.
exemption will be different for pharma and medtech. And the medtech and diagnostic sector is being cautious because AI systems that are medical devices will be ‘high risk’.”
The upshot is that, for better or worse, this may indeed create some extra work for manufacturers. After all, despite the regulators’ best intentions, it would be rare to find a new set of regulatory requirements that did not cause some procedural delays. The AI Act is no exception. “The informal feedback we’re getting,” says Murovec, “is a bit of fear that this will indeed slow everything down.”
August 1st
The date that the AI Act becomes fully applicable, in most cases.
European Union $15.7tn
The potential contribution to the global economy from AI by 2030.
PwC 20 2026
Embedded vs non-embedded AI An interesting feature of the new rules is that they apply to ‘non-embedded’ AI just as much as they do ‘embedded’ systems. In simple terms, embedded AI is physically integrated into a product, whereas non-embedded AI isn’t. The healthcare sector contains many examples of non-embedded AI, including AI-powered symptom checkers and AI modules analysing electronic health records. While conceding that the distinction around embedded AI may seem slightly archaic, Murovec nonetheless thinks it’s an important clarification. “For example,” he says, “we have clients who have very specific computer hardware, and unloaded on that hardware is software that interrogates images and then uses an algorithm to predict the likelihood of a heart attack. Clearly, that is loaded onto a physical system. But equally, it doesn’t need to be. The cloud-based set-up is going to be just as important, if not more so, in the future.” Embedded AI, for its part, is no less important, covering devices as varied as wearable health monitors, medical robots and diagnostics equipment. Either way, these are the types of technologies that are often already covered by the MDR/IVDR, and the
ones that could face duplicative or conflicting requirements under the AI Act. As the main European trade organisation representing the industry’s interests, MedTech Europe is therefore focusing its energies here. “This remains our primary concern,” emphasises Olbrechts, “and we continue to advocate for clear interplay between the AI Act’s requirements for high-risk AI systems and those of MDR/IVDR.”
Staying relevant
While AI is clearly a broad and fast-developing category, the AI Act has been crafted with an ambitious goal in mind: to remain applicable and effective as technology evolves.
“I think we’ll capture a lot of scenarios,” says James. “And, of course, the European Commission is empowered to enact guidelines on certain questions, which can be updated depending on technologies’ advancements. So when we look to the future and what could be placed on the market in ten, 20 years, I think it will still probably be relevant.” We obviously can’t say for sure what’s coming
down the line – especially when it comes to something as dynamic and unpredictable as AI. That said, the new regulation should be able to accommodate a wide range of future scenarios, as algorithms become ever more pervasive across healthcare. Given how much there is to play for – not least enhanced diagnosis, more equitable health access, and improved connectivity among doctors – Murovec hopes that the AI Act will serve to foster greater trust in these technologies.
“I think it will increase transparency, it will increase accessibility, and it will increase literacy in AI technology,” he says. “I think that’s really important for patients. It’s also essential for healthcare providers, even though it might take some time before we get there.” ●
Medical Device Developments /
www.nsmedicaldevices.com
Ivan Marc/
Shutterstock.com
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