The European Commission published an FAQ document for implementing and satisfying the UDI System requirements set forth in the EU Medical Device Regulations 2017/745 and 2017/746.
The FAQ document covers compliance dates, the Basic UDI-DI, labeling requirements, and other important information for medical device manufacturers. To view the complete FAQ document click here.
To learn more about HIBCC and UDI, visit www.hibcc.org.
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements
- 30 Oct 2019Important Notice to HIBCC Labelers
- 30 Oct 2019European Commission confirms two year delay for the launch of EUDAMED. Labeling deadlines are not affected by this delay.
- 11 Oct 2019The HIBC UDI-Builder is now available. This tool will allow you to create, calculate, confirm, and collect UDIs.
- 09 Oct 2019European Union Medical Device Coordination Group (MDCG) releases document concerning the validity of existing certificates