With EUDAMED having become mandatory, we wanted to answer a simple question:
Are the health AI companies that have solutions on the market in Europe actually now visible in the European regulatory system?
In Europe, there has historically been no central public database where hospitals, healthcare professionals, or researchers could easily confirm whether a company’s AI solution was truly CE-marked. Companies could claim regulatory approval, but independently checking this information was often difficult. This is one of the reasons of existence of Health AI Register - we verify it. Interestingly enough the European Commission previously leveraged our database for a large analysis on AI adoption in Europe as an alternative was lacking.
This stands in contrast to the United States, where the FDA maintains a central and searchable database. There, users can look up companies and devices, review regulatory summaries, and access information such as intended use and validation documentation. They even have a separate view for FDA cleared AI devices.
Europe has long lacked a comparable level of transparency.
That is now beginning to change. Since 28 May 2026, registration in EUDAMED is no longer optional. Under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), all medical device companies operating in Europe must be registered in the system. This includes companies developing AI solutions in fields such as radiology and pathology. From 28 November 2026 onwards, individual devices must also be registered.
EUDAMED — the European Database on Medical Devices — was created to improve transparency, traceability, and regulatory oversight across the European medical device market. The database is intended to make it easier for regulators, hospitals, procurement teams, and healthcare professionals to identify who is behind a device, whether products are certified, and how they can be traced throughout the European market.
To explore how the health AI market is responding to this new requirement, we cross-checked the companies listed in the Health AI Register databases for radiology and pathology against EUDAMED.
The results revealed a clear difference between the two fields and provide an interesting snapshot of how prepared the health AI market is for this next phase of European medical device regulation.
Cross-checking Health AI Register with EUDAMED
At first, we aimed to verify registrations at the product level by searching for individual AI solutions in EUDAMED. In practice, this turned out to be more difficult than expected.
Commercial product names did not always produce direct matches, and several manufacturers appeared to group multiple products under broader registration entries. In some cases, the names used in EUDAMED differed from the commercial branding commonly used in the market.
To make the analysis more reliable, we therefore focused on the company level. For every company listed in the Health AI Register databases, we assessed whether:
- the company itself could be identified in EUDAMED, and
- at least one associated product registration could be found.
The analysis reflects the status of EUDAMED on 27 May 2026, one day before the mandatory use date.
Most radiology companies have registered
Among radiology AI companies (n=117), we found that:
- 72% had both a company and product registration
- 16% had a company registration only
- 12% could not be identified in EUDAMED
These findings suggest that most radiology AI vendors are already actively preparing for the next important milestone later this year, when individual device registrations become mandatory.
Pathology is getting there
For pathology AI companies (n=34), the results were slightly different:
- 56% had both a company and product registration
- 35% had a company registration only
- 9% could not be identified in EUDAMED
While pathology companies appear somewhat earlier in the transition process, the majority have clearly already taken steps toward compliance.
What do these findings tell us?
Overall, the results are encouraging. Most health AI companies in both radiology and pathology appear to be aware of the new regulatory requirements and have already established at least a company-level presence in EUDAMED.
At the same time, the analysis also highlights some of the growing pains of a system that is still evolving. Even for organizations actively monitoring the AI market, linking commercial AI products to regulatory registrations is not always straightforward.
The companies that could not be identified in EUDAMED raise additional questions. Some may no longer actively focus on the European market despite previously obtaining CE marking.
More broadly, this exercise highlights why EUDAMED matters in the first place. Transparency and traceability are becoming increasingly important as AI tools become more widely implemented in healthcare.
Step 1 is for hospitals and healthcare professionals to be able to find reliable ways to verify whether products are legitimately certified.
Step 2, that I am impatiently waiting for, is to get more transparency on the intended purpose, information on the clinical investigations, and the vigilance data. Some of these features are said to be added to EUDAMED as well, but at the speed of development we have observed so far, I think my patience will be tested.
But let's celebrate what's there now. For the first time, Europe is moving toward a centralized infrastructure that could make this possible.
The coming months will show how complete and usable that system becomes once device-level registrations are fully mandatory later this year.
By Kicky van Leeuwen, PhD
Analysis supported by Nico Frijns
