On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017.
To view the EU press release click here.
- 27 Jan 2020Notice to Labelers: HIBCC Contact Information
- 14 Jan 2020The European Commission announces the European Medical Device Nomenclature (EMDN)
- 17 Dec 2019How to use HIN for Drug Supply Chain Security Act (DSCSA) requirements
- 04 Dec 2019European Commission releases updated EUDAMED Data Dictionary
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements