On 16 December 2025, the European Commission (EC) published a proposal that, if adopted, will harmonise artificial intelligence (AI) Act requirements for medical devices placed on the European market under the European Union’s (EU) sector-specific medical device and in vitro diagnostics regulation (MDR/IVDR).
A fundamental shift of the EC’s proposal would be to remove medical devices from the AI Act’s high-risk artificial intelligence systems (HRAIS) scope. Entered into force on 1 August 2024, the EU AI Act regulation aims to foster responsible AI development and deployment in the EU.
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Under the regulation, HRAIS must comply with requirements including risk-mitigation systems, the provision of high-quality datasets, and the provision of clear user information and human oversight. Under the EC’s proposed shift, conformity assessment for AI-enabled medical devices would instead be entirely managed under the EU MDR.
Participants in the European medical device space have grappled with the MDR/IVDR since its initial introduction in 2017. Since then, delays have abounded, and the regulation has drawn criticism from market participants over a lack of clarity in satisfying its obligations, among other factors. For these reasons, research indicates that the regulation is hindering innovation in Europe.
By removing AI medical devices from the AI Act’s scope and instead evaluating them entirely under the MDR/IVDR, the EC’s intention is that the shift would reduce duplicative paperwork and other administrative burdens for those in scope of both regulations.
The advantages of harmonisation
Stronger harmonisation between the AI Act and the MDR represents a “real opportunity” to streamline conformity assessment – a move that would allow manufacturers and Notified Bodies to work within a “more unified framework that supports innovation while maintaining robust safety and performance standards”, according to DNV.
The Norway-headquartered Notified Body’s director of global certification for medical devices, Alexey Shiryaev, states: “While these requirements come at a time when harmonised standards are still emerging and capacity is already stretched under the MDR/IVDR, strengthening these competencies now will ultimately enhance our ability to assess advanced technologies and provide manufacturers with even higher‑quality guidance.”
Having engaged with the EC prior to its proposal’s publication, Stephen Gilbert, professor of medical device regulatory science at the Dresden University of Technology, says there are some elements he anticipated, but several inclusions that came as a surprise.
“I wasn’t entirely expecting the shift of the AI Act provisions out of the AI Act in the horizontal legislation, and moving them into the MDR and IVDR overall,” Gilbert says.
Many stakeholders had argued that the requirements for the regulation of AI-enabled devices, including high-risk devices, should be in the MDR and IVDR directly, according to Gilbert. The case for this action is that it should lead to a smoother process where there was clarity on the linking of the requirements under the MDR and the requirements of the AI Act, Gilbert says, yet many observers were resigned to the fact that this was “unlikely to happen”.
Gilbert welcomes the AI Act’s inclusion in the MDR, but with one “major caveat” in that it is unclear when and if this will happen. Although the EU parliament agreed by a large majority on 26 March on moving MDR and IVDR from Annex I Section A to Section B of the AI-Act, there are still many steps of the legislative process to go, and Gilbert’s view is that the shift will likely result in a “disorderly transition” period ahead of the benefits of these changes becoming a reality. Legal observers anticipate that the proposal could be finalised by summer 2026 or by 2027 at the latest, although this remains to be seen.
Gilbert notes that it remains uncertain how, when or even whether all the AI Act requirements will be incorporated into the MDR, or an “MDR-associated Implementing Act legislation.” He has been collaborating with private lawyers aligned with medtech organisations to research some of these themes.
He continues: “Some of the new requirements of the AI Act for medical devices are important and should not be left in prolonged hiatus. It’s completely needed that we have requirements of Article 14 of the AI act on human oversight. It’s particularly important. And I do think there is a need for strengthening some aspects of transparency around AI more explicitly than as currently dealt with in any existing aspect of the MDR/IVDR.”
It remains unclear when these proposals may get completed, approved, and implemented, or whether they will come back in the same promulgated form, Gilbert concludes. “If they come back in the same form, it could be that they manage to package everything together so that it works better in practice,” he says. “That would be the best outcome.”
The Notified Body knock-on effect
In navigating the MDR/IVDR’s requirements, which must be accomplished on a staggered timeline for companies to be able to continue marketing their medical devices or IVDs in the EU, bottlenecks have predominantly existed due to a lack of Notified Bodies. Participants in the EU medtech space, previously in conversation with Medical Device Network, have lambasted these factors.
Gilbert’s view, however, is that the harmonisation proposal could generate a different sort of bottleneck for Notified Bodies, one fuelled more by uncertainty vis-à-vis preparedness versus a simple lack of Notified Bodies to certify firms going through the regulatory process.
“Let’s say that the current law still applies, that the proposal is only a proposal. The AI Act deadlines already apply, but there was no real progress, because it wasn’t so much about bottlenecks of unavailability of Notified Bodies or them not being ready, but rather as to the designation of those Notified Bodies to fulfil this role being ready,” Gilbert says.
In effect, the bottleneck Gilbert foresees is one centred on uncertainty over what is actually required by companies in scope, over “when it is required, how is it required, and what the structures in place for it being delivered will be”.
Acknowledging that this creates more uncertainty, Gilbert’s view is that it is a necessary situation. DNV strikes a similar sentiment yet notes that while the regulatory landscape is still evolving, the development of new AI‑related standards and clearer expectations offers a “valuable chance to create a more future‑ready conformity system”.
“Although integrating AI‑specific obligations into existing MDR processes adds complexity and comes at a time of high demand on Notified Body capacity, these advances will ultimately support innovation, strengthen consistency across Europe, and help ensure trustworthy AI‑enabled medical devices reach patients safely,” Shiryaev says.
Christian Espinosa, CEO of Blue Goat Cyber, a company that assists medtech manufacturers in meeting regulatory requirements around cybersecurity and related compliance matters, highlights that it may be “overly presumptuous” of the EC to assume that Notified Bodies will be sufficiently placed to handle AI medical device evaluation.
“AI evaluation is a skillset that can be challenging to master, so I think that as this regulatory shift progresses, we’ll see more specialities and Notified Bodies arise because the landscape is becoming more complex, thus requiring more of a niche skillset,” Espinosa says.
Espinosa points to a Notified Body that Blue Goat recently engaged with that has decided to focus only on software-based medical devices and AI.
“I think this is interesting, as they’re not trying to be like some of the other Notified Bodies that do everything. They’re becoming more specific, and I think we’ll see more of that evolve,” he says.
At first glance, the EC’s proposals may appear to be further complicating matters for medical device companies required to comply with both the MDR/IVDR and the AI Act. Notwithstanding the potential for a disorderly transition period, the move toward a more integrated and aligned framework could ultimately benefit those subject to both regimes, should the harmonisation proposal be adopted.
Regardless of whether the AI Act is harmonised with the MDR/IVDR, Gilbert’s closing view is that the delta between the MDR/IVDR and the AI Act’s requirements is relatively limited.
“If you were in a responsible company with a Quality Management System (QMS), developing AI- enabled products before the AI Act, you were likely already doing most of the things that the AI Act required,” he says.
