In one sentence:
Only the manufacturer can assign the UDI code of a medical device and register it in Eudamed. Neither the distributor, nor the authorised representative, nor the importer can do so, even if they sell the device under their own brand.
What is a UDI?
It is like a unique “barcode” that identifies each medical device, so it can be traced on the European market (Eudamed).
What was the problem?
Some distributors sell a device under their own brand (with the manufacturer’s permission), and in that case some believed it was acceptable for the distributor itself to request and assign the UDI code in its own name. The MDCG says no: even if the device has two different trade names (the manufacturer’s and the distributor’s), the UDI code must always be issued by and remain linked to the manufacturer, never the distributor.
Can the work be delegated?
Yes. The manufacturer can entrust a third party with handling the process in practice (by contract), but the legal responsibility before the authorities always remains with the manufacturer — it is not transferred.
Legal basis:
the Regulation itself (MDR/IVDR) and its Annex VI already state that it is the manufacturer who must assign and maintain the UDIs, and that only the manufacturer may place them on the device or its packaging. This MDCG document does not change the rule; it only clarifies a misunderstanding that was occurring in practice.