Medical device registration on placement on the market

The manufacturer or the authorised representative of the manufacturer, based in Romania, has the obligation to register with the NAMMDR in accordance with the provisions of Article 6 of Order of the Minister of Health no. 3539 of 2022 on approval of the Methodological Rules regarding the introduction of medical devices on the market and the registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database and exemption from the procedures for assessment of compliance, when placing the following types of medical devices on the market:
a) Class I, IIa, IIb and III medical devices, including sterile and / or measuring devices;
b) Systems and procedure packages referred to in Article 22 of the Regulation;
c) active implantable medical devices

F1 – Notification form for the introduction of medical devices on the market

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Registration of in vitro diagnostic medical devices when placed on the market

The manufacturer or the authorised representative of the manufacturer, based in Romania, who places devices on the market attributable to them, has the obligation to register with the NAMMDR in accordance with the provisions of Article 6 of Order of the Minister of Health no. 3539 of 2022 on approval of the Methodological Rules regarding the introduction of medical devices on the market and the registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database and exemption from the procedures for assessment of compliance, when placing the following types of in vitro diagnostic medical devices on the market:

a) Class A in vitro diagnostic medical devices;

b) Class B in vitro diagnostic medical devices;

c) Class C in vitro diagnostic medical devices;

d) Class D in vitro diagnostic medical devices.

F2 – Notification form for the introduction of in vitro diagnostic medical devices on the market

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Registration of custom-made devices when placed on the market

The manufacturer based in Romania has the obligation to register with the NAMMDR in accordance with the provisions of Art. 3 of Order of the Minister of Health no. 2845 of 2022 on approval of the Methodological rules for approval of provisions of Article 13 of Emergency Government Ordinance no. 46/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) no. 178/2002 and Regulation (EC) no. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania, providing data regarding the address of the registered office and the description of the medical devices which are the subject of their activity.

F.CMD – Notification form for the introduction of custom-made devices on the market

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PLEASE NOTE

The registration of medical devices and in vitro diagnostic medical devices into the national database of medical devices does not represent an approval or an authorization from the NAMMDR, the competent authority in the field of medical devices.
The fee payment form – ISSUANCE OF REGISTRATION CERTIFICATE FOR MEDICAL DEVICES INTO THE NATIONAL DATABASE, REGISTRATION OF MODIFICATION OF INFORMATION FROM THE MEDICAL DEVICES DATABASE – is available on the “Forms and tariffs” webpage.

https://www.anm.ro/dispozitive-medicale/formulare-si-tarife/

Following completion of the form for payment of the fee, please send submit it electronically at registratura@anm.ro or to the NAMMDR headquarters in 48 Aviator Maior Ștefan Sănătescu, Sector 1, 011478, Bucharest, and the respective request shall be invoiced by the NAMMDR.

After payment and its confirmation, you may submit your request by sending an e-mail to drsp@anm.ro or to the NAMMDR headquarters in 48 Aviator Maior Ștefan Sănătescu, Sector 1, 011478, Bucharest.