Under the Regulation, the processes for placing a medical device on the market, putting it into service and distance selling are now explicitly regulated. Devices that are in conformity with the relevant harmonised standards shall be presumed to be in conformity with the requirements of the Regulation. Where the manufacturer of a device is not established in an EU member state or Turkey, the device may only be placed on the market if the manufacturer designates a sole authorised representative in Turkey. In accordance with the Regulation, manufacturers are obliged to register medical devices (except those produced on demand) in the EUDAMED system before placing them on the market. Meanwhile, the local Product Tracking System is still in force.
Various effective dates are laid down for the Regulation's provisions.
First published by Practical Law, in 02.07.2021