The UK Is now Seeking Public Input on Its’ New UDI Regulation

A public consultation request has been launched by UK government as it considers specifications for its’ forthcoming UDI regulation.  The Medicines and Healthcare products Regulatory Agency (MHRA) wants industry stakeholders, as well as the general public, to provide their views on possible changes to the regulatory framework, including UDI requirements, for medical devices in the UK.

The UK is seeking input on topics including UDI assignment rules, Issuing Agencies, and information to be captured in the UK UDI database.  These topics can be found within the Unique Device Identification (UDI) section of the UK web-based Consultation Request, titled “Chapter 4: Registration and UDI”.   

HIBCC labelers are encouraged to participate in the consultation to ensure the upcoming UK UDI requirements conform to existing global UDI regulations (the EU MDR and IVDR and the US FDA’s UDI Rule).   The consultation can be completed online and anonymously in a matter of minutes. You can be included in the consultation by clicking here before the deadline of November 25^th, 2021.

To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at udisupport@hibcc.eu or +1 (602) 381-1091.