Misunderstanding of the definition of Software driving or influencing the use of a device

Hey there!

I am classifying a standalone software under the MDR and MDCG 2019-11 and I have entered in a discussion concerning its classification and the point B of the definition. I recall the definition here below:

Software driving or influencing the use of a device
Software which is intended to drive or influence the use of a (hardware) medical device and does not have or perform a medical purpose on its own, nor does it create information on its own for one or more of the medical purposes described in the definition of a medical device or an in vitro diagnostic medical device. This software can, but is not limited to:
(a) operate, modify the state of, or control the device either through an interface (e.g., software, hardware) or via the operator of this device
(b) or supply output related to the (hardware) functioning of that device
Note: Software driving or influencing the use of a (hardware) medical device may be qualified as an accessory for a (hardware) medical device.

Point B means that any output related to the device falls under this definition, then, for example, if I have a web based software that receives data (i.e xml format) related to the functioning of a medical device (lets say a class III device) and I print it (here is the output), then the mentioned software would fall under the definition of 'software driving or influencing the use of a device'!?

Moreover, directly in MDR annex VIII point 3.3 states:

3.3. Software, which drives a device or influences the use of a device, shall fall within the same class as the device.

If the software is independent of any other device, it shall be classified in its own right. --> If I follow this, then the software should be classified in its own right, however, the software purpose is just to print this info, then it would not fit now the medical device definition.


Then there are two/three ways to follow:

A) the standalone software falls in the definition of 'software driving or influencing the use of a device' but it is not a medical device itself, then the software must cover the GSPR only.
B) The standalone software falls under the same class of the device (lets say class III), and it must be registered with a regualtory authority and all the endless documentation for a class III device? even if it only prints a pdf?

and C) (which i would prefer but i dont know how can i fall in this) The software does not fit within the 'software driving or influencing a device' definition and the sw is not realted to the MDR. (maybe argumenting that the sw is just for storing, formatting and printing the data? )


I hope you could help me, i feel im running in circles.

Thanks in advance

Only one additional comment, output data is defined in MDCG 2019-11 as follows:

Output data:
Any data produced by a software can be considered as an output data. Output data examples (nonexhaustive): - Screen display data (such as layout with number, characters, picture, graphics, etc.); - Print data (such as layout with number, characters, picture, graphics, etc.); - Audio data; - Digital document (formatted for a general purpose such as Word file or pdf file or jpeg image, or formatted for medical purpose such as DICOM file or ECG records or Electronic Health Record, unformatted document). - Haptic buzzing as an alternative to audio sound