Announcement of first four EUDAMED database modules' full functionality

Following extensive postponements, the European Commission has at last issued a Decision on the notice regarding the full functionality of first four EUDAMED database modules in the Official Journal of the EU (OJEU) on November 27, 2025.

The Decision concerns specifically modules listed below, which are considered to be fully functional since November 27, 2025:

1. Actor registration Module (ACT) for registration of economic actors

2. UDI / Device registration Module (UDI / DEV) for registration of devices and their UDIs

3. Notified bodies & Certificates Module (NB / CRF) for notified bodies and MDR / IVDR certificate management

4. Market Surveillance Module (MS)  for monitoring devices on the market

This step started a sequence of relatively short transitional periods in which all of the requirements linked to the EUDAMED database are to be met. The obligatory usage of the EUDAMED database is determined to start on May 28, 2026.

Below we bring you a summary of obligations.

Which obligations and deadlines are connected to the EUDAMED database?

A) Immediate obligations of all relevant economic operators – Role / Actor registration in the ACT Module

All the relevant economic operators shall register in the EUDAMED database in accordance with Art. 31 of the Regulation (EU) 2017/745 (MDR) and Art. 28 of the Regulation (EU) 2017/746 (IVDR).

It namely concerns following types of Roles / Actors, for whom the registration is necessary:

• Medical device or IVD Manufacturer – applies to manufacturers of custom implantable devices with Risk class III as well

• Importer

• Authorized Representative

• System & Procedure pack Producer

Note 1: If the economic operator takes on multiple roles it is imperative to register every role separately as different Actors. An operator that practices manufacturing as well as import activities is going to have to perform a pair of separate registrations – one for manufacturer, one for importer – and manage both Actors. The operator will also recieve two different SRNs.

Note 2: Distributor does not have the obligation to register in the EUDAMED database and it  not even made technically possible. All responsibilites related to the registration of distributors are connected to the national ISZP database.

The deadline for fulfillment of this obligation is set on May 27, 2026.

Moreover, the operators registration is completely free until May 27, 2026. If registered after this date, the manufacturer will have to pay one-time administrative fee of 3.000 CZK to the Czech market surveillance authority SÚKL for registration of every role separately. No more fees are connected to the EUDAMED database yet. The registration is in addition authorized by SÚKL, therefore we recommend performing it as soon as possible to achieve timely approval for your registration.

B) Immedeate obligations of Importer in ACT Module

Notification obligations remain at the RZPRO database level until May 27, 2026. However, based on the latest information from SÚKL, importers will be allowed to fulfill their notification obligations through the EUDAMED database instead of the RZPRO database on a voluntary basis. In order to fulfill the obligations in the EUDAMED database, it is necessary for the importer to be registered as an operator and at the same time to establish links to manufacturers based outside the EU. Importers do not link to specific imported devices nor do they register them. However, the MDR and IVDR impose an obligation on importers to check the registration of devices by non-EU manufacturers and its validity.

The deadline for fulfillment of this obligation is set on May 27, 2026

C) Immediate obligations of Systems and Procedure packs Manufacturers and Producers – UDI / DEV Module

Notification obligations remain at the RZPRO database level until May 27, 2026. Obligations and deadlines related to the registration of devices in the EUDAMED database are linked to the date of placing the device, system or procedure pack on the market (see options C.1 and C.2).

C.1. Devices, Systems and Procedure packs placed on the market up to May 27, 2026

The manufacturer is given 12 months, starting from November 27, 2025, to register devices in the EUDAMED database. To fulfill the registration obligation, the device must have the registration status "Registered" (for some devices subject to certification, this status will only occur upon confirmation of registration by the notified body that issued the relevant certificate, and notified bodies have until May 27, 2027 to do so), or at least the "Submitted" status. This obligation applies to both NEW DEVICES (including systems and procedure packs) placed on the market under the MDR/IVDR and LEGACY DEVICES placed on the market under previous directives (MDD, AIMDD, and IVDD).

The deadline for fulfillment of this obligation in EUDAMED is set on November 27, 2026

Example:  A manufacturer placed first batch of a device on the market on November 29, 2025, and will continue to place the device on the market after the start of mandatory use of the EUDAMED database, i.e., from May 28, 2026 onward. In order to comply with the EUDAMED database requirements, the manufacturer must be registered in this database by November 27, 2026. The registration obligation is considered fulfilled upon submission of the registration form (status "Submitted"), therefore the manufacturer does not have to wait for the notified body to upload the certificates to the database. At the same time, manufacturer has to fulfill their notification obligation in the national RZPRO database until May 27, 2026, especially in the case of applications for a Certificate of Free Sale, which are still processed through the RZPRO system.

C.2. Devices, Systems and Procedure packs placed on the market from May 28, 2026 onward

Before placing a device on the market, it must always be registered in the EUDAMED database. To fulfill the registration obligation, the device must have the registration status "Registered."

The deadline for fulfillment of this obligation in EUDAMED is set immediately before placing the device on the market.

Example: A manufacturer will place first batch of a device on the market on June 1, 2026. Before placing the device on the market, the manufacturer must register the device in the EUDAMED database. The registration obligation is considered fulfilled when the registration form reaches the publication status in the public section of the database (i.e., the "Registered" status). In the case of EU Type-Examination Certificate or EU Technical Documentation Assessment Certificate, the device must not be placed on the market until the certificate has been uploaded by the notified body. In all other cases, the obligation is fulfilled by submitting the registration form, as the data is automatically transferred to the public section of the database (status "Registered"). Moreover, the manufacturer no longer has to fulfill any notification obligations in the RZPRO database.

Author: Jakub Musil