This article has been updated to include comments from the British IVD Association.
NEW YORK – The European Parliament's vote to support phasing in the use of Eudamed, the European Database on Medical Devices, making parts of it mandatory for makers of in vitro diagnostics as of the beginning of 2026, has been welcomed with some caution by industry.
While Eudamed is at the center of Europe's new In Vitro Diagnostic Regulation, its rollout has taken longer than expected and only some of its modules are currently operational and have been tested. That looks set to change this year, as the first modules of the database are expected to be finalized by the European Commission, though other parts of Eudamed remain years away from completion.
The purpose of Eudamed is to maintain a database of all medical devices and IVDs on most of the European market, creating transparency for the public and healthcare professionals, and to enhance coordination between the different member states. The countries covered by the IVDR include the EU, as well as the European Economic Area member states Iceland, Norway, and Liechtenstein, plus Turkey and Northern Ireland.
The information contained in the database — such as market surveillance data — is used to fulfill elements of the IVDR. In its final form Eudamed will have six modules: actor registration; unique device identification (UDI) and device registration; notified bodies and certificates; clinical investigations and performance studies; post-market surveillance and vigilance; and market surveillance.
Currently, the first three modules are available and can be used on a voluntary basis by test makers, while the market surveillance and post-market surveillance and vigilance modules should be ready for use later this year. The module covering clinical investigation and performance studies is not expected to be operational before the end of 2026, however.
While use of Eudamed was originally supposed to become mandatory when all modules were completed, the lag in progress of the project led the European Commission to propose this past January to gradually phase in modules as part of a set of measures to amend the MDR and the IVDR, such as an obligation to report interruption or discontinuation of supply of certain devices by IVD manufacturers, and a revision of grace periods for legacy devices under the IVDR.
Parliament recently voted to support this proposal, which among other things, will mandate using the parts of the database that are ready by January 2026, or as soon as the modules are audited and declared to be functional. Once the proposal is published in the Official Journal of the European Union, it will be considered to take effect.
Industry has welcomed the decision with some reservations.
Katalin Máté, senior expert for regulatory affairs at MedTech Europe, a Brussels-based trade association that represents the medical technology industry, including IVD makers, said the new decision to make using Eudamed mandatory is welcome, "provided that essential preconditions are met."
What are MedTech Europe's preconditions? Module development and readiness, for one. The association believes that the database's modules should be "fully developed, rigorously tested, audited, and ready for practical implementation" before their use is mandated.
The association has also called for "realistic implementation timelines," Máté said, adding "clear and achievable timelines" for the rollout of the various modules will be "crucial" and will "help ensure smooth integration and minimize disruptions to operations."
Finally, MedTech Europe supports the elimination of redundancy in national databases, meaning that once Eudamed is up and running, there will be no need to register every device in every country, as is currently necessary. Instead, devices will need to be registered only in Eudamed. This will help to "streamline data management processes and promote consistency across Europe," she said.
Stuart Angell, head of regulatory affairs at the British IVD Association, had a similar perspective. While he said the association is "broadly supportive" of the update, BIVDA would like the European Commission to "provide clear and regular updates on the progress and guidance of each module in Eudamed as they are developed, tested and audited," Angell said.
"The sooner we get the industry to transfer data into the system, the more we can understand the functionality of Eudamed within the wider context of the IVD Regulation," he added.
MedTech Europe, along with several other European organizations, sent a letter to the Directorate-General for Health and Food Safety (DG-SANTE) at the end of last year regarding this last concern, noting that companies' administrative resources have been "stretched to comply with national database requirements to register economic operators and device data."
Despite these concerns, Máté underscored that Eudamed is a "critical infrastructure" for both the IVDR and its sister regulation, the Medical Device Regulation (MDR). "It's intended to be an enabler: a central platform to provide regulatory oversight of devices, transparency for the public, and enhanced collaboration between economic operators, competent authorities, and notified bodies," she said.
As noted, the first five modules of Eudamed — actor registration; UDI/devices; notified bodies/certificates; market surveillance; and post-market surveillance and vigilance — are expected to be finalized by the Commission this year to achieve the minimum viable product functionalities necessary to carry out a successful audit of the system. Industry has been and is participating in the testing of the system to "eliminate bugs and enhance the IT platform's usability," Máté said.
The spider in the web
According to Erik Vollebregt, a lawyer at Amsterdam-based Axon Lawyers who specializes in regulatory issues related to medical devices, the recent decision by the EC to phase in Eudamed over time reflects a shift in strategy. Originally, he noted, the database was supposed to be finished during the transitional period after the IVDR was enacted in 2017 but in any event before the date of application in May 2022.
"The strategy for Eudamed was that it would come online in a big bang," Vollebregt remarked.
By the end of 2019, though, it became clear that this was not going to happen, leading to a variety of strategies among EU member states, although the commission asked the member states not to complicate matters with local databases and related requirements, he said. Nevertheless, some member states developed or already had their own databases for medical devices and IVDs, while others, like Finland and the Netherlands, have decided to treat registration in the modules as they became available for voluntary use the same as if they had been registered in their national databases.
Because the delayed big bang introduction of Eudamed would only increase this developing national complexity, the commission decided to opt for amending the MDR and IVDR to make use of the database mandatory in stages.
Vollebregt underscored that Eudamed is important to both the IVDR and MDR because it serves as a "circulatory system" for the regulations, in that the regulations need the data contained in Eudamed to properly function. Eudamed provides information on economic operators that links devices, certificates, economic operators and associated safety and performance data that is intended to be made public, such as the summary of safety and performance for high-risk IVDs, for example.
"Eudamed is the spider in the web for a lot of processes," said Vollebregt, “and this is one of the reasons the MDR and IVDR still have not realized their full potential."
For IVD makers, who under the previous regulatory system, 1998's IVD Directive, largely relied on a self-certification process to sell their products, interacting with Eudamed is a new world.
"They have gone from a situation of relative anarchy to one where they suddenly need to go to a notified body to get a CE-IVD mark," said Vollebregt. "This is a huge game changer for industry in that there is a third party looking at their technical documentation. Many of the smaller and midsized IVD companies are still completely unprepared for what this means for their technical documentation and underlying performance data." he said.
Adjusting to this new reality, by preparing their submissions and entering their data once use of Eudamed becomes mandatory in 2026, is no simple task either. According to Richard Houlihan, CEO and founder of EirMed, a Brussels-based company that specializes in helping companies with their Eudamed submissions, this is a project that "should not be underestimated."
Houlihan said that manufacturers should "seriously approach Eudamed as a matter of urgency," as it could take months and external help to ready one's submissions. Houlihan founded EirMed in 2019 after running the Eudamed IT teams at the European Commission for eight years. "It became apparent to me that manufacturers were going to struggle," he said of the impetus for setting up the company, which also has an office in Sofia, Bulgaria. EirMed is a one-stop shop for Eudamed-related needs, offering training, consulting, and a data submission platform.
Not every company needs external help, Houlihan noted, but the level of knowledge required to successfully navigate the database and its required data submissions is "substantial," he said. Moreover, consultants are ever more in demand, meaning companies seeking help will probably be put on a waiting list.
Demand is also up since the European Parliament voted on the proposal that companies would be expected to use Eudamed by the start of 2026. "Now there is certainty and dates the manufacturers will have to meet," said Houlihan. "So, a lot of companies are starting to realize how big these projects can be, and that in turn is keeping us very busy."
Does the size of the company have an impact on the burden, though? Houlihan said that it depends. EirMed deals with customers who have thousands of devices and some who have just a handful, but both have expressed reticence toward interacting with the database, as it's out of the purview of their in-house IT teams. He said it would cost a company, optimistically, about $600,000 to build a system that would meet most of the requirements for Eudamed, assuming it had the know-how beforehand. But any system would need to be maintained and flexible to react to any change in the Eudamed database implemented by the EC.
For example, Houlihan said the commission has said it will review the database in 2027, which might lead to "major updates and data requirements by 2030," so building one's own in-house system would require years of investments and maintenance. Or they could work with partners.
Máté said that it's up to the companies to decide which approach to take with Eudamed.
"It depends on the number of devices a company has," she said. "If the manufacturer’s portfolio is significant, they could potentially contract a third-party service provider to help manage their submissions to Eudamed," she said. "Each company should assess their expected traffic with Eudamed and decide which option would fit the best to manage this traffic."
Whatever approach they choose, Vollebregt said companies should get serious about their Eudamed submissions, as well as gaining compliance for their devices with the IVDR, even as the grace periods for certain devices holding CE-IVD marks under the IVDD are extended.
"Clients typically underinvest in proper training for people to use Eudamed and to understand technical documentation and performance data requirements for the IVDR more broadly, or they start too late," Vollebregt said. "The people who have to do the work are not sufficiently trained and are underresourced. That's what I see, typically, where the problems with Eudamed and IVDR implementation in the broader sense are concerned."