Last fall, I sat across from a mid-sized European medical technology manufacturer who told me something that has stuck with me. They had developed an AI-assisted mammography screening tool with strong clinical evidence behind it, one that could detect early signs of breast cancer more accurately and to a greater extent than current screening programs allow. They didn’t wait for science to catch up. They were waiting for someone to tell them which regulation applied.
The EU is moving fast in The digital omnibus in AI proposal, an initiative that aims to simplify and future-proof Europe’s digital regulation, with key discussions in the European Parliament expected in the coming weeks and a political compromise to follow in the coming months. It is a welcome step. But the question is whether it goes far enough. In health care, a framework that is not about ambition is not simplification. It’s a throwback. And the current trajectory, if not corrected, points in that direction.
Speed is not the same as readiness
The high-risk obligations of the AI Act should not apply until the conditions for compliance actually exist. Harmonized standards have been finalized. Notified bodies with real capacity. Regulatory guidelines that manufacturers can follow. A two-year implementation period that begins only after these conditions are met is not a concession to industry. It is a fundamental respect for how complex regulated systems work.
The reality today is grim. Notified bodies are prepared unevenly in all Member States. Harmonized standards remain incomplete. The instructions are fragmented and, in some areas, completely absent. Launching mandatory obligations in that environment does not accelerate the safe adoption of AI. It produces documents while innovation waits, and patients wait with it.
One designation, not two
The bottleneck is not theoretical. Manufacturers developing AI-enabled medical technologies must navigate both the AI Act and the sectoral framework, the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Each path has its own requirements, its own timeline, and its own points of failure. The cumulative effect is delay: for manufacturers, for notified bodies and ultimately for patients who need these technologies now, not in three years.
The current Digital Omnibus proposal allows for a single application and unified assessment for dual determination. This is good progress. But a unified process built on separate legal requirements is not true harmonization. It is an administrative regulation. What is needed is a definitional framework that actually reduces burden, not one that consolidates forms while leaving the underlying complexity intact. Policymakers know the difference. This is the moment to act on it.
A more coherent approach is already emerging in ongoing review of MDR and IVDR. Instead of forcing companies through two parallel sets of rules, the Commission now proposes to align the AI Act with the medical device framework so that specific AI requirements are addressed through the MDR/IVDR process itself. This reduces duplication, keeps a notified body in charge of the full assessment, and ensures that medical oversight of UA is within the system designed for patient safety and clinical effectiveness.
The problem of regulation
The AI Act introduces the concepts of “substantial modification” and “safety component” to determine when high-risk classification and Notified Body involvement is triggered. Both concepts are defined in the AI Act, but have no equivalent in the MDR or IVDR, creating uncertainty for manufacturers as to when an AI-enabled device needs reassessment.
To a policy maker, this may seem like a technical detail to be resolved in guidance. For a manufacturer deciding whether their adaptive AI system requires full recertification, it’s a legal gray area that delays decisions, increases costs, and in some cases stops products from moving forward entirely. The cumulative costs across hundreds of AI-enabled medical technologies, in time, resources and delayed patient access, are real and growing.
Alignment of definitions across the AI Act and sectoral legislation requires political will, not technical genius. Leaving guidance documents to resolve years later is a choice. And it’s wrong. Without regulatory coherence between the AI Act and the MDR/IVDR, companies are forced to follow parallel tracks of evaluation for a single product, an inefficiency that helps no one, least of all patients.
What is really at stake?
The US and China are not stopping to resolve the issue of the route of determination. They are building clinical trials, establishing market presence and quietly setting the standards that the rest of the world will follow.
Europe does not need to match their pace. It should be smarter. The digital omnibus is a real opportunity to make the EU regulatory framework for AI in healthcare a source of competitive confidence rather than strategic uncertainty. What it requires is straightforward, even if not achieved: legal certainty, definitions that match legislative frameworks, determination pathways that work as intended, and timelines based on operational reality rather than political convenience.
None of this is radical. It is the minimum necessary to ensure that Europe’s regulatory ambition is translated into outcomes that actually reach patients. Right now, that gap is wider than it needs to be, and the window to close it is narrowing.
Alexander Olbrechts, Director Digital Health & Medtech Value, MedTech Europe
About Alexander Olbrechts
As Director of Digital Health and Medtech Value at MedTech Europe, Alexander oversees all activities related to digital regulations affecting the medical technology sector. Key areas of focus include artificial intelligence, data management and governance, the European Health Data Space and cyber resilience.
Before joining MedTech Europe, Alexander was employed by the Belgian technology association and actively participated in many other European associations. In addition, he held positions as a business unit manager, product manager, and medical advisor in both the medical technology and pharmaceutical industries. Throughout his professional career, he has consistently demonstrated a strong commitment to advancing digital health.
Alexander holds multiple degrees in Biomedical Sciences, Medical Imaging and Healthcare Management. As a Belgian citizen and native Dutch speaker, he is fluent in French and English. In his spare time, Alexander enjoys participating in triathlons and indulging his passion for skiing during the winter season.
