The use of the first four Eudamed modules will be mandatory as of 28.05.2026. Manufacturers and distributors of systems and treatment units must register their existing products in the UDI/Product-Module with a further transition period until 27.11.2026 at the latest.
With Regulation (EU) 2024/1860, the EU legislator enabled the gradual introduction of modules for the European database in June 2024. With Decision (EU) 2025/2371 of 26.11.2025, the Commission has now notified the functionality of certain Eudamed modules in accordance with Art. 34(1) of Regulation (EU) 2017/745 (‘MDR’). This decision was published on 27.11.2025 in the Official Journal of the European Union.
This confirms that the following Eudamed modules are functional and meet the functional specifications set out in Art. 34(2) MDR:
- the electronic system for the registration of economic operators – ‘Actor Module’ (Art. 30 MDR / Art. 27 IVDR) (Please note: this module has been mandatory for use at national level since 26.05.2021, as announced by the Federal Ministry of Health);
- the UDI database and the electronic system for registering products – ‘UDI/Device Registration’ (Art. 28 and 29 MDR / Art. 25 and 26 IVDR);
- the electronic system for notified bodies and certificates – ‘Notified Bodies and Certificates’ (Art. 57 MDR / Art. 52 IVDR);
- the electronic system on market surveillance – ‘Market Surveillance’ (Art. 100 MDR / Art. 95 IVDR).
In accordance with Art. 123(3)(d) MDR, the publication in the Official Journal of the European Union marks the start of a six-month transition period for the mandatory use of these Eudamed modules. After this period, the modules must be used on a mandatory basis ‘from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3)’.
In particular, the following deadlines apply to manufacturers of medical devices and IVDs as well as to distributors of systems and treatment units (Art. 22 MDR) for registering their products in Eudamed:
- Product registration in the UDI/product module is mandatory as of 28.05.2026.
- For series of existing products that are placed on the market before 28.05.2026 with a specific UDI-DI, a transition period of 12 months from the publication of the notice on functionality (Art. 123(3)(e) MDR) applies. These existing products must therefore be entered into the UDI/Product-Module until 27.11.2026 if they are to continue to be distributed with this UDI-DI after 27.11.2026.
- This means that product series that are to be placed on the market with a new UDI-DI as of 28.05.2026 must be registered in the UDI/Product-Module before the first product is placed on the market, without any further transition period.
Do you have any questions about this news or would you like to discuss it with the author? Please contact: Prof. Dr. Boris Handorn
