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 LAA (Local Actor Administrator) 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-udamed/actor-ludul-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.