Registration into the EUDAMED database

The NAMMDR checks the data entered by economic operators into the European database on medical devices (EUDAMED) and evaluates the registration request which can be validated, rejects or may request corrections. Following validation, a single registration number (SRN) is generated.

If the economic operator has several tasks (manufacturer, authorised representative, importer, producer of systems and packages of procedures), separate records shall be made for each task and different SRNs shall be obtained.

The subsequent modification of the data from the registration on the EUDAMED platform is made only by the Local Actor Administrator (LAA) and does not involve the competent authority in its validation. Data change does not change the obtained SRN.

For details regarding the registration module of economic operators into the EUDAMED, we suggest you consult the guideline available on the website of the European Commission (https://ec.europa.eu/health/medical-devices-eudamed/actor-registration-module_en#user-guide-for-economic-operators)

Furthermore, for any issue/concern, we recommend using the EUDAMED assistance e-mail: SANTE-EUDAMED-SUPPORT@ec.europa.eu.
The form for the payment of the fee – Validation/Verification of registration into the Eudamed database is available for download on the Forms and fees webpage.
https://www.anm.ro/dispozitive-medicale/formulare-si-tarife/
A payment form shall be filled in for each application for registration into the EUDAMED.

Following completion of the form for payment of the fee, it shall be submitted to the NAMMDR headquarters in 48 Aviator Maior Ștefan Sănătescu, Sector 1, 011478, Bucharest, or electronically to the following e-mail address: registratura@anm.ro, and the respective request shall be invoiced by the NAMMDR. After payment and its confirmation, the application for registration into the EUDAMED database shall be evaluated.

The European Commission has published and made available to economic operators two essential guidelines, in order to facilitate the registration process into the European Database on Medical Devices (Eudamed).

download document – Actor module for Economic Operators …

download document – UDI Devices …

These guidelines are designed to support economic operators in fulfilling their registration obligations, as provided for in the Medical Devices Regulation (EU) 2017/745 (MDR) and in vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR).

Consulting them ensures correct and complete registration of your data.

The European Commission published in the Official Journal of the European Union Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (EUDAMED):

https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=OJ:L_202502371

This confirms that the following electronic systems included in the EUDAMED are operational and meet the functional specifications referred to in Article 34(2) of Regulation (EU) 2017/745:

• the electronic system for the registration of economic operators (Actor registration) – referred to in Article 30 of Regulation (EU) 2017/745(MDR) and in Article 27 of Regulation (EU) 2017/746(IVDR);

• the UDI database and the electronic system for device registration (UDI/Device registration) – referred to in Articles 28 and 29 of Regulation (EU) 2017/745(MDR) and in Articles 25 and 26 of Regulation (EU) 2017/746(IVDR);

• the electronic system on notified bodies and certificates (Notified Bodies and Certificates module) – referred to in Article 57 of Regulation (EU) 2017/745(MDR) and in Article 52 of Regulation (EU) 2017/746(IVDR);

• the electronic market surveillance system (Market Surveillance) – referred to in Article 100 of Regulation (EU) 2017/745(MDR) and in Article 95 of Regulation (EU) 2017/746(IVDR).

The obligations and requirements related to the Eudamed apply from the date corresponding to a 6-month period from the date of the aforementioned publication (in accordance with Art. 123 of the MDR, Art. 113 of the IVDR), namely from 28 May 2026.

According to the provisions of Art. 123 of the MDR/Art. 113 of the IVDR, the deadlines for registration into the EUDAMED are as follows:

Modules	Registration officer	Mandatory use	Extension of the registration period	Observations
Actor registration	Manufacturer	28 May 2026	–	Mandatory for all economic operators, including legacy devices
	Authorised representative
	Importer
	Manufacturer of systems and procedure packs
UDI/Devices	Manufacturer	28 May 2026	+6 months from 28 May 2026* (12 months from the publication of Commission Decision (EU) 2025/2371)	*For medical devices placed on the market before 28 May 2026
	Manufacturer of systems and procedure packs
	Authorised representative (depending on the nomination mandate)
Notified bodies and certificates	Notified body	28 May 2026	+12 months from 28 May 2026* (18 months from the publication of Commission Decision (EU) 2025/2371)	*For certificates issued before 28 May 2026. Only the latest version of the certificate shall be registered.