What are the obligations of economic operators and health institutions in relation to UDI under EU MDR and IVDR?

Modified on Wed, 28 Aug at 8:21 PM

​All economic operators and health institutions shall store and keep preferably by electronic means the UDI of the devices, which they have supplied or with which they have been supplied if those devices belong to class III implantable devices.
Please note that the Commission may decide to adopt implementing acts to expand the scope of devices for which economic operators shall store and keep the UDI.

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