Legal & Tax Alerts

New provisions in the field of medical devices, approved by the Romanian Government

On June 9, 2021, the Romanian Government approved, at the request of the Ministry of Health, new provisions on placing on the market and making available on the market medical devices for human use and accessories for such devices[1]. The new rules were published in the Romanian Official Gazette no. 588, Part I on June 11, 2021, and they become applicable starting from today, June 14, 2021.

In a nutshell, through the most important provisions of the new regulations:

the Romanian National Agency for Medicines and Medical Devices (“ANMDMR”) is designated as the competent authority in the field of medical devices, as well as the market surveillance authority in this regard;

were introduced special provisions in order to ensure the transparency and traceability of medical devices, for improving health and safety, by using the Unique Identification System of a medical device;

was expressly established the obligation to make available on the market of the medical devices accompanied by instructions for use in the Romanian language;

were provided clarifications regarding the language in which the information provided as part of a software system of a medical device must be drafted (i.e., the user interface of a medical device intended for professional use may be available, for justified reasons, in English, only with the prior written consent of the user, but for those intended for non-specialists use, the interface must be in the Romanian language).

were established the conditions under which the export of medical devices from the Romanian territory can be carried out;

were introduced provisions regarding the advertising of medical devices, being established that ANMDMR is the competent authority for the assessment, notification, and approval of advertising materials and any other form of advertising on medical devices;

were established sanctions that will be applicable in the event of non-compliance with the provisions of the European Regulation on medical devices.

 

[1] Government Emergency Ordinance no. 46/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions 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, Regulation (EC) no. 178/2002 and Regulation (EC) no. 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC.

Cookie Settings