Starting today, 26.05.2021, Directives 90/385 / EEC and 93/42 / EEC on the regime of medical devices (transposed into Romanian legislation by Decision no. 54 and 55 of 2009) were repealed by European Regulation no. 745/2017 on medical devices (with certain limited exceptions provided in the new regulation). We mention the fact that the entry into force of this regulation was postponed for reasons related to the current pandemic context, being initially established for 26.05.2020.

Regulation no. 745/2017 on medical devices brings changes and clarifications regarding the obligations of manufacturers, importers, distributors and authorized representatives.

According to the European regulation, in case the authorized representative is changed, this approach must be clearly defined in an agreement concluded between the manufacturer, the changed authorized representative, if possible and the new authorized representative. It is known that if the manufacturer of a device is not established in a Member State, the device may be placed on the Union market only if the manufacturer designates a single authorized representative.

Another change brought by the European regulation is the one that requires commercial companies (including micro-enterprises) that carry out operations with medical devices (trade / import / storage, etc.) to designate at company level a person responsible for the compliance with regulation provisions. This person will periodically attend the applicable training courses in the field of medical devices, as approved by the A.N.M.D.M.R.

The new European Regulation is applicable to all EU Member States and aims to ensure the proper functioning of the internal market for medical devices. The need for such a normative act is given by the scale of activities carried out by economic operators in the national and international pharma market, as well as by the need to make them responsible, but also of the Member States involved.