UDI assignment Criteria Software IVDR

Z

Zjiel

#1
#1
Hi all,

I was hoping to get some of your insights on the IVDR, regarding the UDI assignment Criteria for software the IVDR under Annex VI, Part C states:

"6.2.1. UDI assignment Criteria
The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement."

So in case of software which is not stand-alone by definition, but still commercially available separate from a physical IVD instrument, should this software have an UDI? Or am I misreading this and is it aimed at stand-alone only?

Thanks,

Gilles
 
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