28 May 2028 marks the end of the transitional periods established by Commission Decision (EU) 2025/2371 of 26 November 2025. From today, the use of the four electronic systems of EUDAMED, the European database on medical devices, is fully mandatory for economic operators. The voluntary nature that has characterised the database since its launch is now definitively no longer in force.
Where does the date of 28 May 2026 for the obligation to use EUDAMED come from?
Commission Decision 2025/2371, published in the Official Journal of the EU on 27 November 2025, formally confirmed the operational readiness of the four EUDAMED modules and triggered the transitional periods provided for in Article 123(3)(d) to (ec) of Regulation (EU) 2017/745 (MDR) and Article 113(3)(f) to (fd) of Regulation (EU) 2017/746 (IVDR). The 30-month transitional period from the date of that publication ends on 28 May 2028. For manufacturers and other economic operators active on the EU market, there is now no way to circumvent this obligation.
Which modules are becoming mandatory?
The obligation applies to all four modules confirmed by the 2025 decision. The economic operator registration system (Article 30 MDR/Article 27 IVDR) requires manufacturers, authorised representatives, importers and distributors to hold a valid SRN number. Without it, neither the registration of a device nor the maintenance of certification is possible. The UDI database and the device registration system (Articles 28–29 MDR / Articles 25–26 IVDR) require that the identification data for each device, namely the UDI-DI and UDI-PI codes, be complete, up to date and consistent with the label and technical documentation.
This obligation also covers the system relating to notified bodies and certificates (Article 57 of the MDR / Article 52 of the IVDR), in which all valid conformity assessment certificates issued by a notified body for a given manufacturer must be visible. The fourth module, the market surveillance system (Article 100 of the MDR / Article 95 of the IVDR), becomes, as of today, the mandatory channel for reporting serious incidents and field safety corrective actions (FSCA), replacing the existing national channels wherever the MDR and IVDR designate EUDAMED as the relevant register.
What are the consequences of failing to register?
Entities that have not yet registered or have incomplete data in the system face direct regulatory consequences. Competent national authorities are authorised to initiate supervisory proceedings against devices that are not correctly listed in the UDI database, and notified bodies may refuse to carry out surveillance audits or suspend the issuance of a certificate until the data is completed. In practice, this means a risk of the CE marking being challenged and the need to suspend the placing of the device on the EU market.
The most urgent actions today
Regulatory Affairs and Quality Assurance departments should first confirm the validity of the SRN number for each entity operating in the supply chain. Next, the completeness of UDI records for the entire product portfolio must be verified, and it must be ensured that conformity assessment certificates are visible and correctly assigned in the module concerning notified bodies. Quality Management System (QMS) procedures regarding incident reporting and FSCA require urgent updating to include new reporting pathways via the market surveillance module. Organisations that have been using EUDAMED on a voluntary basis for the past two and a half years should now only need to undergo a formal verification; the rest face the need for immediate action.
Source: Commission Decision (EU) 2025/2371