Own-Brand Distribution Under MDR/IVDR: Who May Assign the UDI-DI?
Anna SahlholmConsultant manager, GBA Key2Compliance When the same medical device is sold under different trade names, it may seem logical for each brand owner to obtain its own UDI-DI. Under the EU MDR and IVDR, however, the decisive question is not who owns the brand, but who acts as the legal manufacturer. MDCG 2026-5 addresses […]