Euro Convergence: Expert offers advice on making the best of EUDAMED

BRUSSELS – The European database on medical devices (EUDAMED) may feel burdensome to medical device manufacturers, but an expert says it can also be an opportunity for companies to represent their products. He also said legacy device manufacturers should consider uploading their product information to the database – even if it’s not required at the moment – for greater visibility.

EUDAMED was launched in 2020 and is a centralized database for medical devices, in vitro diagnostics (IVDs), and manufacturer information in the EU. It includes six modules that cover actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, market surveillance, post-market surveillance, and clinical investigations and performance studies. At the moment, only the actor registration, UDI/device registration, and notified bodies and certificates modules are live, though the remaining modules are set to come online in the coming years according the gradual roll out plan adopted last year.

While EUDAMED meant to provide greater transparency to the public about the products sold on the European market, it also requires additional effort from manufacturers.

“EUDAMED is a pain … you guys are never going to make money off of it,” said EirMed CEO Richard Houlihan during a presentation at RAPS Euro Convergence 2025. “It is going to be an expense for all of you, but you have no choice. You have to use it. So why not embrace it?”

“Think of it as a marketing exercise,” he added.

Houlihan, who has advised companies to comply with EUDAMED, said they should treat the database like a product catalog. He noted that distributors, importers, and other stakeholders are already using the system to look for specific products and their European Medical Device Nomenclature (EMDN) codes. He said they’re targeting manufacturers by searching EUDAMED for companies that are supplying specific kinds of products.

Houlihan said manufacturers can use the additional description field to include sales information and a URL so interested individuals can find more information about the product. He also said they can include well-curated images of their product. However, he emphasized that the manufacturer needs to be very accurate about the information they upload and be aware of the kind of information they upload to the system.

“Don't forget that everybody can see your data in the device module,” said Houlihan. “Everything you enter in the device module is public. You make mistakes, it's public.”

“My strongest advice at the beginning: Upload a few devices, a few UDIs, and go and check them,” he added.

While manufacturers can always go back and fix their mistakes, Houlihan noted that past versions of the records are available publicly, so the mistakes are never truly erased. To completely resolve the problem, the manufacturer may need to delete each UDI individually and reupload them, which can be arduous. He also recommended that manufacturers should upload the data in a planned way instead of dumping all the data into the system at once to minimize potential errors.

“There's going to be summaries of safety information, clinical investigations, performance studies, market surveillance … a lot of confidential information in there, a lot of business-critical information in there, business-sensitive stuff, so not everything is going to be put up there,” said Houlihan.

To find out what will be publicly available, Houlihan recommended manufacturers find the data dictionary, a spreadsheet with a list of all the fields in EUDAMED. He noted that specific fields in the vigilance and clinical modules may contain sensitive information.

“Just make 100% sure, first of all, you're not identifying anything that can identify a patient, and that you don't put any secret information into all the fields, that's confidential,” said Houlihan. “I know these are very obvious things to say, but people make these mistakes.”

Houlihan said that while manufacturers are not required to upload their legacy devices to EUDAMED, he strongly advises that they do so. He noted that their products often have decades of data. With the Medical Device Regulation (MDR) certification requirements, stakeholders can more readily see the history of their product on the system.

When they submit their product to EUDAMED, manufacturers are asked to assign their device levels of detail depending on several factors. Houlihan noted that they must enter the product into the lowest level. Still, he’s faced situations where the manufacturer has insisted on entering the product into a higher level only to be denied by EUDAMED. He recommended that manufacturers avoid making such mistakes because they waste time.

Euro Convergence: Expert offers advice on making the best of EUDAMED

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