#23 How to distinguish between multiple instances of identical software-as-a-device

[Björn Andersen]

As per the EU MDR, software-as-a-device instances may have the same UDI if they are identical. The UDI can therefore not be used to identify a deployed instance (as opposed to physical devices that carry unique PIs). It may thus be necessary to introduce an additional requirement to generate a unique (SDC) instance identifier before participating in the SOMDS. (To be discussed at next Wednesday's call?)

[Björn Andersen]

After 30 Oct 2019 tCon:
More generally speaking, we probably need to set down a requirement that requires a unique X.509 certificate for each deployded instance of a software. That applies to MDR regulated software as well as to components that are not software-as-a-medical-device.

[Stefan Schlichting]

Add a Note 11 that clarifies if and how R0045 applies to SaaMD esp. SaaMD instances.