The UK plans to designate HIBCC as an Issuing Entity in its upcoming UDI Regulation
Yesterday (6/26/22), the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) published its official response to the Future Regulation of Medical Devices Consultation (initially launched in 2021). The consultation included a substantial section on the implementation of UDI.
An overwhelming number of respondents expressed the need for consistency among existing and future UDI regulations, including the designation of multiple issuing entities. MHRA responded “we intend to designate GS1, HIBCC, ICCBBA and IFA as UDI issuing entities, as a clear majority of respondents supported this option, and it presents an opportunity to align with other jurisdictions.”
To view MHRA’s Full Response to the Consultation click here.
To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at udisupport@hibcc.eu or +1 (602) 381-1091.