The European Commission has designated HIBCC to be a Unique Device Identifier (UDI) Issuing Agency as part of the European Union Medical Device Regulation (MDR), which will apply to all EU member nations. HIBCC’s EU Issuing Entity designation was announced on June 7th, 2019. HIBCC has been an Issuing Agency for the U.S. FDA’s UDI Rule since 2013.
HIBCC will be deploying additional support and guidance to its European constituents to assist them as they implement processes in accordance with the EU MDR.
To view the official EU Issuing Entity designation click here.
To view the entire release from the Official Journal of the European Union click here.
To learn more about EU UDI requirements click here or contact HIBCC directly at email@example.com or (602) 381-1091.
- 15 Jun 2020Register now for our HIBCC UDI Webinar
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- 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