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EU MDR Classification Rule 11 – what???

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.


  1. Ferruccio Miglietta Ferruccio Miglietta September 25, 2019

    Annex VIII of IVDR says “(1.4) If the software is independent of any other device, it shall be classified in its own right”, but there are no more indications about its classification.
    Does this sentence mean that “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes” (MDR Rule 11) has to be classified as MD even if it is used as IVD?

    This is a doubt I also have about MDD and IVDD.

    Thanks a lot,

    Ferruccio Miglietta

    • Marcelo Antunes Marcelo Antunes Post author | September 25, 2019

      Hi Ferrucio, in fact I was talking about the MDR, but please note that the same text “(1.4) If the software is independent of any other device, it shall be classified in its own right”, also appears in the MDR. It means that if the software is a SaMD, it is classified independently. If the software is “embedded”, only the medical device is classified (the software is considered a component of the medical device only).

      • Ferruccio Miglietta Ferruccio Miglietta September 25, 2019

        Hi Marculo,
        Thank-You for Your kind reply.
        I have this doubt regarding software as IVD: How can a software be classified when it can be used for helping diagnosis in association with different IVD kits manufactured by different Manufacturers? Should it be classified according to MDR rule 11, or according to IVDR? If it is a IVD, which class does it belong?
        I mean MDR is clearer than IVDR regarding software classification.
        Thank-You again,

        • Marcelo Antunes Marcelo Antunes Post author | September 25, 2019

          Hi Ferrucio

          I think the confusion is related to the applicability. If the software is a in vitro diagnostic medical device as per the IVDDR, the IVDR applied. The MDR only applies if it’s a medical device as per the MDR.

          In you example, all the different kits to be used in conjunction with the software would need to be taken into consideration, and the highest classification would apply (this concept is the same used in the MDR, in fact, for other types of devices).

  2. Marcelo Antunes Marcelo Antunes Post author | September 25, 2019

    A correction of my original post which may be misleading – All rules are for medical devices, not for software. Rule 11 applies for a medical device that is a software in itself, that’s what I wanted to say. It does not apply to software embedded in a medical device because this software is not a medical device in itself, so classification rules cannot apply to it.

  3. Marcelo Antunes Marcelo Antunes Post author | September 26, 2019

    Another possible interpretation of the implementation rules (which makes more sense in my opinion) is that the part “Software, which drives a device or influences the use of a device, shall fall within the same class as the device”only applied to embedded software. This would be in line with older rules and expectations (even the MDD has the same requirement in Annex IX) and thus would mean that SaMD would only apply rule 11 (which makes more sense because it was created for SaMD). The only problem is that tule 11 does not seem to include SaMD2 in my comment.

  4. Marcelo Antunes Marcelo Antunes Post author | September 26, 2019

    However, this last interpretation does not fit in current guidance such as Meddev 2.1/6 (for example, it says: All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb according to implementing rule 2.3.
    Example: radiotherapy planning system used to calculate the dose of ionizing radiation to be administered to the patient, insulin dosage planning stand alone software.)

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