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.
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
- 26 May 2020FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.
- 29 Apr 2020European Commission publishes guidance document on regulatory requirements for ventilators
- 15 Apr 2020Chronicled’s Mediledger utilizing the HIBCC HIN identifier for Contracting and Chargebacks in its’ blockchain network
- 15 Apr 2020HINAPI is now available