Seminar on EUDAMED and National Databases: German Experience for Ukraine

On 3 March 2026, an online seminar was held within the framework of the EU–Ukraine Twinning Project “Support to the establishment of the state control authority for medicines and medical devices.” The event focused on the European Database on Medical Devices (EUDAMED) and the role of national information systems in implementing EU regulatory requirements.

The seminar brought together experts from the Federal Institute for Drugs and Medical Devices (BfArM), Germany, representatives of the State Service of Ukraine on Medicines and Drugs Control (SMDC), and Twinning project experts.

Participants included Lina Seibokiene, Resident Twinning Adviser, Kathrin Lange, Head of the Unit “Research, Data Management and Analytics” at BfArM, as well as Annette Bruchner and Svenja Wieschrath, Chief Specialists from the same unit. The Ukrainian side was represented, among others, by Volodymyr Chekalin, Head of the Department for State Market Surveillance of Medical Devices at the SMDC.

The European Database on Medical Devices

During the seminar, the German experts presented an overview of EUDAMED, a European information system supporting regulatory processes under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The database contains information on:

• medical devices placed on the EU market;
• manufacturers and authorised representatives;
• conformity certificates;
• clinical investigations and performance studies;
• reports on serious incidents.

It was noted that once the system becomes fully operational, most information in EUDAMED will be publicly accessible, while certain safety-related data will remain restricted to competent authorities.

Main Modules of EUDAMED

The BfArM experts presented the key modules of EUDAMED, including:

• Actors Module – registration of manufacturers and authorised representatives;
• Devices Module – registration of medical devices;
• Certificates Module – registration of certificates issued by notified bodies;
• Market Surveillance Module – information on market surveillance activities;
• Vigilance Module – reporting of serious incidents and field safety corrective actions;
• Clinical Investigations / Performance Studies Module – data on clinical investigations and performance studies.

The modules are interconnected, allowing information on manufacturers, devices and certificates to be linked within the system.

Implementation Timeline

It was highlighted that EUDAMED is not yet fully operational.

The Actors, Devices, Certificates, and Market Surveillance modules are expected to become fully functional in May. The Vigilance module is planned to be launched in the first half of 2027, while the Clinical Investigations / Performance Studies module remains under development.

Before a module becomes mandatory, the European Commission must formally confirm that it is fully functional.

National Information Systems

The seminar also addressed the potential use of additional national information systems alongside EUDAMED.

Experts explained that EUDAMED does not cover all regulatory procedures and is not designed to manage internal workflows within competent authorities.

In Germany, this role is performed by DMIDS (German Medical Devices Information and Database System), which serves as a portal for applications, notifications, and reports and supports coordination between competent authorities.

It was emphasised that EU legislation does not require Member States to establish national databases, although such systems may be useful to support administrative procedures.

Discussion and Next Steps

During the discussion, Ukrainian participants raised questions regarding access to information in EUDAMED, registration of certificates, and classification of medical devices.

The experts also emphasised that manufacturers must enter their data directly into EUDAMED using their own accounts, and such information cannot be transmitted to the system through national databases.

At the end of the meeting, the BfArM experts shared useful EUDAMED resources and offered further expert support if additional questions arise.

The presentation delivered during the seminar is attached for reference.