20.03.2025
To the attention of healthcare institutions
On 27 February 2025, Part I, Order of the Minister of Health No. 650 was published, in the Official Gazette of Romania, Part I, on approval of the procedural rules for the application of the provisions of Art. 5 (5) 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, of Regulation (EC) no. 178/2002 and Regulation (EC) no. 1.223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC of the Council on medical devices and in vitro diagnostic medical devices manufactured and used only within healthcare institutions.
This Order regulates the aspects regarding the manufacture and use of medical devices / in vitro diagnostic medical devices within healthcare institutions as well as the aspects regarding the notification of the use of such devices to the NAMMDR. The regulatory document is available online, in the section Medical Devices/ Legislation/Orders of the Minister of Health.
The form used for the notification of the manufacture and use of such medical devices can be found in the section “Medical/Forms and fees” coded as F.MD/IVD_IS. Please be advised that the analysis of the notification and the related file is an Order of the Minister of Health tariff activity no. 3.467/17.11.2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices, with the amount of indexed tariffs 2025.
The payment form related to this activity can be found in the section “Medical / forms and fees”, named “Form for payment of the tariff – Evaluation File of notification of medical devices manufactured and used within public or private healthcare units / evaluation of the File for notification of a modification of medical devices used within public or private healthcare units”