Shall a new UDI-DI be required when stand-alone software device's version is updated?

#1
Hello,
We have an In vitro diagnostic device as software only. This device is web-based and has no components in which a physical label could be placed. All updates are applied through the web and users cannot control the "version" used. Every couple of weeks we release a new version of the software that fixes certain bugs, adds features, etc, all within the defined Indications for Use.

Are we to obtain a new DI for every software release? Everything I've read indicates the DI must change along with changes to "versions of models". This all depends on how you interpret "versions or models". When looking at IVDR Annex VI Part C "The UDI System" Cl.3.9,

[IVDR Annex VI Part C Cl.3.9]
A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a) Name or trade name,
(b) device version or model,
(c) labelled as single use,
(d) packaged sterile,
(e) need for sterilization before use,
(f) quantity of devices provided in a package,
(g) critical warnings or contra-indications.

this doesn't seem helpful except for the hint that this threshold is defined by us, the labeler(?)

Would you agree that our DI would stay the same for new releases as long as there are no major changes? - With this, our PI would be revised every release, as our manufacturing date is reflected in our software version number.

Hope that makes sense. Thanks!
 
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