MedTech, the European trade association for the medical technology industry, published a document to provide guidance on the assignment of Basic UDI-DIs. The Basic UDI-DI is a required element of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The Basic UDI-DI will be included in the EU’s EUDAMED database and is referenced in relevant documentation (i.e. certificates and technical documentation).
To view the MedTech Guidance on Basic UDI-DI Assignment click here.
To generate the HIBC Basic UDI-DI and view additional guidance click here.
HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at email@example.com or +1 (602) 381-1091.
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