A New ISO Standard for IVD Performance Evaluation Is Taking Shape
Performance evaluation is central to demonstrating conformity under the EU IVDR. To date manufacturers have typically established their performance evaluation frameworks by drawing on the Regulation, MDCG guidance and several standards addressing individual parts of the evidence lifecycle. A new ISO project, currently under development, may eventually provide a more consolidated international reference for performance […]
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 […]