Software driving or influencing the use of a device

Under MDCG 2019-11, such software is regulated together with the hardware device it drives, as a part of it or as an accessory, rather than qualified on its own. Under MDR Annex VIII it takes the class of the device it drives or influences.

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

MDCG 2019-11 Rev.1, Section 2, Definitions and abbreviations