A mandate for manufacturers to register their devices or in vitro diagnostics (IVD) in a new database for medical devices in Europe is on the horizon.
The European Commission (EC) has outlined six modules as part of its European Database on Medical Devices (EUDAMED), with adherence to the first four modules mandatory from 1 January 2026.
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The first EUDAMED module, Actor Registration, means device manufacturers, importers, and authorised representatives must obtain a single registration number (SRN). The module serves as a “gateway” to compliance with the regulation’s other measures.
By January 2026, manufacturers must also register the unique device identifier (UDI) of their medical device or IVD in EUDAMED. Adherence to this module is mandatory for devices newly certified under the EU Medical Device Regulation (EU MDR) or the EU In Vitro Diagnostic Regulation (EU IVDR) by January while legacy devices or IVDs have a 12-month grace period. According to the EC, this module is designed to centralise EU medical device data and ensure traceability.
Under EUDAMED’s Notified Bodies and Certificates module, manufacturers must register their CE mark certificates issued by Notified Bodies in EUDAMED. Meanwhile, the final module of the four set for implementation by January 2026, Market Oversight, that grants approvals to EU authorities to coordinate inspections, audits, and enforcement actions to promote consistent device oversight across Member States.
Full compliance expected by 2027
EUDAMED’s final two modules relate to clinical investigation performance studies and vigilance and post-market surveillance, with each anticipated to become mandatory by 2027.
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By GlobalDataIn essence, EUDAMED is a system with the overall intent to heighten and simplify the market oversight, transparency, and surveillance of medical devices and IVDs marketed in Europe.
Dr Oliver Eikenberg, global QA/RA manager at life science consultancy Pure Global, told Medical Device Network: “This system is important because manufacturers need the data being requested, and authorities need it, too.
“Manufacturers need it to, for instance, identify similar devices which could have already been CE marked under the EU MDR, information that is required under the EU MDR as part of their clinical evidence.
“EUDAMED will also serve as a platform whereby manufacturers can readily demonstrate that they are in compliance with regulations such as the EU MDR or EU IVDR.”
The EU MDR’s implementation period exists on a staggered timeline to 31 December 2028, with variable requirements dependent on a device’s class. The EU IVDR’s implementation period is similar, with the transition period concluding by 31 December 2029 for Class A and B IVDs.
Eikenberg advises medical device manufacturers and others in the scope of EUDAMED not to delay completion of the four modules effective from January 2026.
He added: “I strongly recommend that manufacturers start this process now, to not delay the collection of the required information and add it to EUDAMED. From there, those in scope can use any remaining time before the mandatory implementation in January 2026 to evaluate any other elements they may be missing to complete the currently ‘active’ modules.”
According to Eikenberg, the EC has envisioned the implementation of EUDAMED since the early 1990s, and given various delays amounting to over 30 years, they are now strongly pushing for it.
“Manufacturers need to have many of the specific elements of EUDAMED, such as a CRN number, when applying with a Notified Body for a CE marking anyway,” Eikenberg noted.
Overall purpose and potential consequences of non-compliance
Once in effect, EUDAMED’s Market Surveillance Module will function similarly to the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) early alert pilot programme. Launched in November 2024, the pilot aims to improve the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.
Eikenberg said: “Compliance with EUDAMED will also automatically mean that with this data provided, manufacturers will easily be able to demonstrate the safety of their marketed products in a broad sense, since they will not be under the radar of a specific European Member State.
“Previously, there have been discussions about different Member States handling device issues differently. EUDAMED provides a significant opportunity to focus on potential high-risk device issues at a much broader level across the EU.”
While the EC has made no specific statement about what non-compliance with EUDAMED’s first four modules by January 2026 could mean, Eikenberg’s view is that the EC could begin taking action against manufacturers that have not at least begun taking action on the requirements.
Eikenberg emphasised: “Don’t wait until this happens, because it’s not going to go away.
“Manufacturers need to have much of this data within their technical documentation anyway. And even if it’s not 100%, it doesn’t matter; put it into EUDAMED, try to close the gaps, and reduce the business risk.”
