There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to join the discussion there.
Here is my comment:
Heh. It’s curious how this is already creating a workload of discussions.
Anyway, some historical info:
– Everyone (medical device people) used to use the word “standalone software” when a software was itself a device. However, when we were discussing this in the IMDRF software working group, it was noted that “standalone software” could be understood differently by software programmers with no medical device experience (and those were a special concern for the working group) so we ended up “creating” the term Software as Medical Device for the IMDRF documents.
– One of the confusing things with SaMD is that most of them work as IVDs (thus the focus of the categorization IMDRF document) – let’s call it SaMD1 – but a small percentage works as a common medical device (therapy, etc.) – Let’s call it SaMD2.
– Initial drafts of the MDR used the word “standalone software”, but this was removed.
– GSPR item 17 is a little more clear on the distinction:
[QUOTE]17. Electronic programmable systems—devices that incorporate electronic programmable systems and software that are devices in themselves[/QUOTE]
– So, we basically have two types of software under the MDR? – Soft1 – devices that incorporate EPS (including software), and Soft2 – SaMD (can be SaMD1 or SaMD2)(please note that the MDR do not use this terminology).
In fact, we have 3. Soft3 – software that is incorporated into a device but is commercially available on its own (see the UDI requirements on Annex IV 6.5. Device Software).
(historical note – Soft1 was usually called “embedded software”. Soft3 would be then something like “embedded software is commercially available on its own”)
– Finally, from a generic perspective, Soft1 is a device which is not software (and the software is part of it). Software 2 is a device in itself. Soft3 is like Soft1. This is important because, When the MDR mentions only software, it “may” talking about Soft1, Soft2, or both.
Related to the original questions, it seems to me that the OP software is SaMD2 (most SaMD2 would be under the “software, which influences the use of a device (software with drives the device would be Soft1, although some SaMD1 could also influence the use of a device). Please note that, in this case, Rule 11 does not apply, because it’s a rule for software only, and the implementing rules says “Software, which drives a device or influences the use of a device, shall fall within the same class as the device”, meaning, you do not classify the software on it’s own.
Please note that rule 11 is mostly related to SaMD1, as it really mentions only the the types of software that works as IVDs, based on the IMDRF documents. I say mostly here because the second part is a bit weird (Software intended to monitor..) and it seems to be that it was included here as a general backup umbrella for some cases.