28.02.2023
To the attention of all economic operators
Please note that only manufacturers of medical devices outside the European Union are required to appoint a single authorised representative to introduce the device on the EU market.
In line with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, “authorised representative” means any physical or legal person established in the EU who has received and accepted a written mandate from a manufacturer outside the Union, to act on behalf of the manufacturer in relation to specified tasks regarding the latter’s obligations arising from this Regulation.
Only authorised representatives residing in Romania are required to register into the NAMMDR national database, when introducing 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 sets covered by Article 22 of the Regulation;
c) active implantable medical devices.
Authorized representatives residing in other member states of the European Union shall NOT BE REGISTERED into the national database.
Moreover, free sale certificates are issued for export purposes only to authorised representatives residing in Romania.