15.02.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that, starting from 13 February 2023, the Methodological rules for clinical evaluation and clinical investigations have entered into force by being published in the Official Gazette of Romania, Part I, No.120 bis/13.II.2023 of ORDER no. 330 of 13 February 2023 on clinical evaluation and clinical investigations with medical devices and for repeal of Order of the Minister of Health no. 792 of 29 June 2006 on conduct of the procedure for clinical investigation and the procedure for assessment of performance relating to medical devices.
This Order is available online under section Legislation/Medical devices/Orders of the Minister of health/2023.