In-vitro diagnostic medical devices and accessories for in-vitro diagnostic medical devices.

Decree-Law ensuring the implementation in the national legal order of Regulation (EU) 2017/746 of theEuropean Parliament and of the Council of 5 April 2017 on in-vitro diagnostic medical devices.

The present legislative proposal is intended to apply to:

a) in-vitro diagnostic medical devices and accessories for in-vitro diagnostic medical devices, hereinafterreferred to as devices;
b) activities involving devices and/or services provided for in Regulation (EU) 2017/746 and in this Decree-Law, which occur on national territory or are intended for that territory, carried out throughout the entire lifecycle of the device.