If you want to find information on the approval status of medical devices and post-market data in a quick search, you usually use the databases of the US FDA. However, this database naturally only provides information about the status of the products searched for in the U.S. With the creation of Regulations (EU) 2017/745 for medical devices and (EU) 2017/746 for in-vitro diagnostics, the creation of a centralised European database was also planned – namely the EUDAMED database. So far, searches in this database have not been very meaningful, as many economic operators continue to fulfil their reporting obligations via the national databases of the member states due to the lack of modules. With the adoption of the amending Regulation (EU) 2024/1860, the European Union has now decided that the database will be implemented gradually rather than in its entirety. We will give you an overview of what this means for you as an economic operator.
The modules of the EUDAMED database
The aim of the EUDAMED database is to provide authorities, notified bodies, economic operators and patients with a comprehensive picture of the product life cycle of medical devices and IVDs that are to be placed on the market in the European Union (EU). The individual modules collate and process information about the products and the corresponding companies, although the scope of accessible data naturally varies. Authorities can view far more data and information than patients, for example.
Another aim of the database is to speed up and facilitate the exchange of data between member states, particularly in the area of vigilance (see recital 44 of the MDR)
- Manufacturers of medical devices made available on the Union market should register serious incident reports (MIR), field safety corrective action reports (FSCA), field safety notices (FSN), periodic summary reports (PSR) and trend reports as vigilance reporting in the EUDAMED database.
EUDAMED consists of six different electronic systems, also known as modules
They are divided as follows:
- Registration of actors
- Product labelling (UDI) and device registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance
- Market surveillance.
Gradual introduction of EUDAMED in accordance with amending Regulation (EU) 2024/1860
With the publication of Regulation (EU) 2024/1860, the previous procedure of making EUDAMED fully valid only after completion was changed to a gradual validity.
The three active modules that can already be used are
- the module for registering economic operators, which has been available since December 2020. Please note that the module does not provide for the registration of distributors; this may also be required in future via the national databases. By using this module, you will receive your SRN – “Single Registration Number”
- the module for device registration including UDI, which has been available since October 2021 and will provide insight into the medical devices available on the market in future.
- the module on notified bodies and certificates, which has also been available since October 2021, with the exception of the review mechanism and the clinical evaluation consultation procedure (CECP).
The two modules for the registration of economic operators and device registration are currently voluntary, but if they are officially published in the Official Journal of the European Union in July 2025 according to the current timetable, their applicability will be:
- mandatory approx. 6 months later for all MDR-compliant products, i.e. probably from January 2026.
- in place for products that still fall under the MDD exemptions and that would still be placed on the market 6 months after publication under MDD (i.e. presumably after January 2026), there is a transitional period of 12 months, i.e. presumably until July 2026.
Entries in the national databases alone will then no longer be sufficient.
Economic operators therefore have time until the expiry of the deadlines to:
- apply for an SRN (Single Registration Number) via the modules, i.e. register as an economic operator (and)
- submit their products to the UDI system and register them in accordance with the requirements of Annex VI (MDR/IVDR) and MDCG 2020-15
Further, the certificates of performed conformity assessments must be made available online by the notified body. They are also required to upload them 6 months after publication. The notified bodies must have checked the registrations with regard to the valid certificates no later than 18 months after publication.
Two further modules, which were scheduled for release in the second quarter of 2024, will be available in the foreseeable future. The current schedule now envisages
- to also declare the market surveillance module operational in July 2025 and thus make its use mandatory from January 2026
- and to declare the vigilance module functional in January 2026 and thus make its use mandatory from July 2026
The last module (clinical investigations/performance studies) will not be completed before Q3/2026.
At this point, it is generally advisable to start registering the data as quickly as possible in order to make the best possible use of the remaining time. Publications in the Official Journal of the EU could be delayed but could also be brought forward. However, it is clear that incident reports can only be submitted via EUDAMED if the products have already been reported in EUDAMED. This has been clear from question 6 of the EU leaflet on UDI since 2020 (please note, it still references old transition periods in all areas!)
The modules of the EUDAMED database can be accessed in two different ways:
- Interested parties who wish to obtain information using the publicly accessible data can find it via the following link: https://ec.europa.eu/tools/eudamed/#/screen/home
- For economic operators who wish or need to transmit data to EUDAMED, access should be via the following route: https://webgate.ec.europa.eu/eudamed
Further interesting links are certainly the
- UDI Helpdesk (Welcome to EU UDI Helpdesk (europa.eu)) and
- the EU information page on the EUDAMED database (MDR-Eudamed – Welcome to EUDAMED (europa.eu))
- and the UDI Playground https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/
The UDI Playground currently includes all modules. The EU Commission is also asking for feedback from test users:
EUDAMED Playground Environment currently contains six modules on the following topics: Registration of Actors, Unique Device Identification (UDI) and Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance and Market Surveillance. This environment contains valid and falsified data and is intended to be used by stakeholders for testing and providing feedback.
Further information on individual modules can also be found in our articles on the UDI itself, relevant obligations for economic operators and persistent language barriers for economic operators
The use of EUDAMED – and in particular its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on products on the EU market, making it easier to monitor the availability of products. So, if your master data is not yet fit enough to be entered in EUDAMED, please contact us. We will support you with structuring your portfolio and the registration obligations.
Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.