10.10.2022
To the attention of manufacturers of custom-made devices, based in Romania
Please be informed that Order No. 2845 of 29 September 2022 on approval of the Methodological norms for approval of provisions of Article 13 of Emergency Government 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, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania was published in the Official Gazette of Romania No. 977 of 7 October 2022.
This Order is available online under section Legislation/Medical devices/Orders of the Minister of health.
The request form can be downloaded from Forms and tariffs – Medical Devices.