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European regulation on in vitro diagnostic medical devices promulgated
A law establishing the institutional framework and the necessary measures for the implementation of the provisions of Regulation (EU) 2017/746 of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices, was promulgated on Monday by President Klaus Iohannis.
According to the government, which adopted an emergency ordinance regulating these measures, the European regulation sets in place high quality and safety standards for medical devices for in vitro diagnostic, to respond to common safety concerns with such products.
The law adopting the piece of legislation ensures the transparency and traceability of devices and stipulates the obligation of the instructions for their use in the Romanian language.
Preventing the implementation of the European regulation through the lack of adequate measures at the national level runs a risk of infringement.
AGERPRES
