Mandatory use of the EUDAMED database is fast approaching. How much of a burden is it going to be for manufacturers?

A major event shook the entire world of medical devices at the end of November this year. After almost five and a half years of postponements and delays, on November 27, the European Commission published a Decision in the Official Journal of the EU (OJEU) announcing the full functionality of the first four modules of the EUDAMED database. This notification represents a fundamental and absolutely crucial prerequisite for the mandatory use of the EUDAMED database, and so 27 November 2025 marks the beginning of a relatively short but very intense six-month transition period during which economic operators must fulfil their registration obligations under the MDR and IVDR.

The transition period will undoubtedly place a burden on manufacturers and producers of systems / procedure packs. By May 27, 2026, they must register in the Actor registration module for each role they perform separately. At the same time, they face an extremely administratively demanding registration in the UDI / Device registration module, which requires very careful and systematic collection of all relevant data. Registration is required for all devices placed on the market under the MDR / IVDR (including devices / systems) as well as devices placed on the market under older directives (MDD, AIMDD, IVDD).

The deadlines for the obligations associated with this module are somewhat more complex. Devices that will be placed on the market for the first time from May 28, 2026 onwards, have to be always registered in the EUDAMED database immediately before being placed on the market. On the other hand, devices placed on the market for the first time up to May 27, 2026 (and which will continue to be placed on the market after May 28, 2026) can take advantage of a slightly extended transition period and have until November 27, 2026 to register in the EUDAMED database, which provides a certain, albeit limited, time reserve.

The SÚKL interpretation will help reducing the administrative burden

Up to May 27, 2026, the notification obligations in RZPRO will continue to apply in parallel. However, the Czech market surveillance authority SÚKL has announced that in the course of January 2026, it will automatically extend notifications in this system for another five years in order to partially reduce the administrative burden on Czech manufacturers and producers as the administrative burden associated with registration in the EUDAMED database is indeed considerable. During registration, it is necessary to enter approximately 40-50 pieces of information for each variant of a medical device or IVD, and on top of that the database user interface does not allow for the duplication of data. The registration process is therefore extremely time-consuming, not only in terms of entering data into the database, but also in terms of collecting all the required data.

Manufacturers and producers should therefore not delay registration and should start the process as soon as possible. In this context, we would like to draw your attention once again to the Porta Medica bulk data uploading tool "EUDAPORT", which we have developed precisely for the purpose of navigating this demanding process with ease and eliminating the administrative burden on manufacturers and assemblers.

Author: Jakub Musil