EUDAMED is the European database for medical devices and in vitro diagnostics. It links information on economic operators, products, certificates, clinical investigations and performance studies, vigilance, and market surveillance. The system does not constitute an authorization act but provides regulatory information for authorities, market participants, and—in designated areas—the public.
Structure in Six Linked Modules
The database is organized around six modules and a public website. The modules cover registration of actors, UDI and product registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. This structure enables information to be cross-referenced throughout the product lifecycle, for example when a certificate, a product identifier, and an economic operator are brought together in different workflows.
The modules do not capture the same type of data. Actor registration, for example, clarifies the identity and role of a manufacturer or authorized representative. UDI and product data serve to identify a specific product. The module for clinical investigations and performance studies, on the other hand, relates to investigations involving human subjects or samples. Referring to “EUDAMED” as a single register overlooks these different functions and the respective data inputs.
Mandatory Use and Phased Implementation
The European Commission has confirmed the functionality of the first four modules. Since May 28, 2026, the registration of actors, UDI and product registration, notified bodies and certificates, and market surveillance are mandatory. Market surveillance is directed at competent authorities and the Commission. The obligation is based on the notice of functionality and the transitional arrangements for the phased expansion of the system.
The Commission also indicates that the modules for clinical investigations and performance studies as well as for vigilance and post-market surveillance are still under development. For processes in these areas, the relevant transitional and national procedures therefore apply until the respective availability. Project teams should not assume that a module provided for in the system architecture is already activated for the submission of productive study data.
Distinction from Authorization and CTIS
EUDAMED is not an authorization database. A data record or identifier does not replace the manufacturer’s conformity assessment or the involvement of a notified body when required for the product. The database documents regulatory processes and makes certain information accessible; it does not issue a positive opinion on the safety, performance, or clinical benefit of an individual product.
The existing entry “clinical-trials-information-system-ctis” refers to the system for clinical trials with medicinal products under the Clinical Trials Regulation. EUDAMED, on the other hand, belongs to medical device and IVD law and includes product, certificate, and market information in addition to clinical investigations. Both systems require structured data and manage regulatory communication, but their legal bases, data models, and procedures are not interchangeable.
The public website is only part of the EUDAMED architecture. Not all information that companies or authorities process in the modules is publicly visible in the same way. When preparing study and product documentation, it is therefore necessary to distinguish whether information is registered, transmitted to an authority, or published for public inquiry. This avoids false expectations regarding confidentiality and the respective necessary access rights.
Relevance for clinical trials
For medical device investigations and IVDR performance studies, EUDAMED influences the planning of regulatory data flows. Study sponsors must determine which data record is assigned to the product, which to the study, and which to the economic operator. The phased provision of the modules additionally requires a controlled transition between existing national procedures and subsequent European input forms. Unclear responsibilities can lead to contradictory product identifications or delayed submissions.
Full-service CROs such as Mediconomics provide support through registry strategies, reconciliation of product and actor data, maintenance of regulatory master data, and preparation of structured study information. When collaborating with manufacturers, authorized representatives, and investigation sites, they can document which information is already stored in a mandatory module and which data must be submitted through other designated channels.
Data quality has immediate practical consequences: a deviating Basic UDI-DI, an incorrectly assigned manufacturer, or an incomplete certificate complicates subsequent searches for product information. Before submission, reconciliation with the released master data is therefore advisable.
Frequently Asked Questions (FAQ)
Which EUDAMED modules are mandatory as of May 2026?
Mandatory are actor registration, UDI and product registration, notified bodies and certificates, and market surveillance. The last two modules related to clinical and vigilance matters are, according to the Commission, still under development.
Does EUDAMED registration confirm the conformity of a product?
No. Registration captures information in the system. Conformity assessment and the manufacturer’s responsibility remain independent regulatory processes.
Why does a clinical investigation require product identifiers?
The identifier links the study information with the investigated product and its regulatory context. This helps to unambiguously assign versions, manufacturer roles, and subsequent safety information.
Regulatory References
- Regulation (EU) 2017/745, Article 33 and Annex VI—establishes the European database for medical devices.
- Regulation (EU) 2017/746, Article 30 and Annex VI—contains the corresponding basis for IVD data.
- Regulation (EU) 2024/1860—governs the phased expansion of EUDAMED and transitional aspects.
- Implementing Decision (EU) 2025/2371—confirms the functionality of certain electronic systems.
