Mandatory nature of the first four Eudamed modules
The gradual roll-out of EUDAMED, the European database for medical devices, has raised numerous questions amongst economic operators in the sector. Although the platform is not yet fully complete, the first three modules are already available and their use is mandatory once a product ceases to be a “legacy” device and is covered by Regulation (EU) 2017/745. Understanding what these modules are, what they are for and when they should be used is essential for compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
1. What is EUDAMED and why is it so important?
EUDAMED is the centralised database set up by the European Commission to improve the traceability, transparency and oversight of medical devices in the European Union. Its aim is to bring together information that was previously scattered amongst national authorities, notified bodies and economic operators.
Although the full platform will comprise six modules, the first three are currently operational and already allow users to register actors, products and certificates.
2. The 4 modules currently available
Module 1: Actor Registration Module
This module enables manufacturers, authorised representatives and importers to obtain their SRN (Single Registration Number). The SRN is mandatory for:
- Manufacturers based within or outside the EU.
- Authorised representatives.
- Importers.
- Manufacturers of systems and kits.
Without an SRN, it is not possible to carry out other regulatory procedures, such as requesting assessments from a notified body.
Module 2: UDI / Device Registration Module
This module enables the registration of:
- The basic UDI-DI.
- Associated UDI-DIs.
- Essential information on the medical device.
Although full product registration will be mandatory once EUDAMED is fully operational, it is already mandatory in cases where the product is already covered by Regulation 2017/745. Once use begins, the registration must be kept up to date.
Module 3: Notified Bodies and Certificates
This module allows you to:
- Register certificates issued under the MDR/IVDR.
- Update certificates.
- Notify suspensions, withdrawals or restrictions.
For notified bodies, use of the module is mandatory. For manufacturers, it is mandatory to cooperate by providing the necessary information so that the notified body can complete the registration.
Module 4: Market Surveillance
This module is primarily intended for the competent authorities of the Member States and the European Commission. Its purpose is to facilitate the coordination of market surveillance activities, the exchange of information on inspections, investigations and measures taken, and to strengthen the supervision of medical devices and IVDs placed on the market in the European Union.
Although the module is intended for direct use by manufacturers and sponsors of clinical investigations, the competent authorities and the European Commission will have access to these records.
3. Is it compulsory to use these modules? The short answer: yes, in part
The European Commission has confirmed that the four modules declared operational will become compulsory from 28 May 2026, following the publication of the relevant notice in the Official Journal of the European Union.
4. What happens if these modules are not used?
Failure to comply with the requirements may result in:
- Inability to obtain or maintain MDR/IVDR certificates.
- Lack of product traceability.
- Risk of penalties from the competent authorities.
- Problems during internal or external audits.
- Obstacles to marketing products in the EU.
Ultimately, failing to use the available modules may jeopardise the manufacturer’s regulatory compliance.
5. Conclusion: EUDAMED is now a reality and its use cannot be postponed
Although the full platform is still under development, the first four mandatory modules are already part of day-to-day regulatory practice. Obtaining the SRN, registering products, keeping certificates up to date and understanding the role of market surveillance in EUDAMED are essential for operating in the European market with legal certainty.
The recommendation is clear: if you are a manufacturer, authorised representative, importer and/or group representative, you must ensure that you are using the active EUDAMED modules correctly.