14.10.2022
To the attention of medical devices manufacturers and all stakeholders
On 13.10.2022, Emergency ordinance regarding the setup of an institutional framework, as well as the necessary measures, in order to ensure direct application of the provisions of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, was published in the Official Gazette of Romania, Part I, no. 995
The ordinance is available online, under section Medical Devices Legislation – Laws, ordinances and government decisions – 2022