MDCG 2019-11 Step 3

WARNING : In my opinion step 3 of the MDCG 291-11 has a double mistake. One mistake is typographical : lossless compression is missing in the chart. The second one is a more serious conceptual error. Recital 19 of the MDR states: "It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes  set out in the definition  of a medical  device,  qualifies  as a medical device, while  software  for general  purposes,  even when  used in a healthcare  setting,  or software  intended  for life-style and well-being purposes is not a medical device". The qualification of medical device depends on the intended use and it does not depend solely on technical / technological issues. It is wrong to qualify a device on technical / technical / technological  issues without taking into account its intended purpose. If a manufacturer establishes an intended purpose within the definition of a medical device, this software is a medical device. My opinion is that MDCG 2019-11 step 3 is in contrast to MDR recital 19. In fact, for the guideline if the software that performs only an action on the data, of "archiving, archiving, communication, simple search or lossless compression" is not a medical device regardless of the intended use. This in my opinion is unacceptable and it does not comply with recital 19.