24.10.2024
To the attention of professional users of medical devices
We inform you that starting with 24.10.2024, the provisions of Art. 933 (1) l) of Law 95/2006 enter into force, namely:
Art. 933 – (1) In order to ensure the level of security and performance appropriate to the purpose for which the medical devices are made and to avoid potential incidents, users are obliged to:
k) to ensure that they only use medical devices when, in the course of their professional activities, they use equipment for the purpose of diagnosing, preventing, monitoring, predicting, prognosticating, treating or alleviating a disease, as defined in Article 2, point 1, first indent of Regulation (EU) 2017/745;
l)*) to comply with the provisions of point k) for medical devices put into operation and in use prior to the entry into force of the deadline provided for in Art. V paragraph (3) of Government Ordinance no. 37/2022 on amendment and supplementation of Law No. 95/2006 on healthcare reform and of Law No. 227/2015 regarding the Fiscal code, and on establishment of other measures in the healthcare field, approved as amended and supplemented through Law no. 328/2022.
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*) The provisions of point l), introduced by Emergency Ordinance no. 88/2023, enter into force on 24 October 2024 (see Art. IX paragraph (1) point c) of Emergency Ordinance no. 88/2023)

The NAMMDR, as the competent authority in the field of medical devices, supervises and controls whether the requirements of the legal regulations are observed, through thematic controls. These controls shall be carried out both on economic operators who import, sell/distribute and perform activities in the field of medical devices and on professional users who use them.
Thus, within the controls that will be carried out by the NAMMDR on professional users of medical devices, it shall be verified whether there are only medical devices used within the professional activity of diagnosis, prevention, monitoring, prediction, prognosis, treatment or improvement of a disease.