13.12.2022
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that Order no. 3539 of 24 November on approval of the Methodological rules for placement on the market of medical devices and registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database, and on waiver from compliance assessment procedures, was published in the Official Gazette of Romania No. 1180 of 9 December 2022.
This Order is available online under section Legislation/Medical devices/Orders of the Minister of health.
The request forms can be downloaded from Forms and tariffs – Medical Devices.