a recommendation about any changes).

Also, the EU provides recommendations on types of software that should generally not be considered as medical devices. These are mobile apps for communication between patient and caregivers while giving birth or for viewing the anatomy of the human body; software for interpretation of particular guidelines or mobile apps for managing pictures of moles like recording updates and changes over time.

As indicated by the World Health Organization [@WHODEVICE], software can be considered as a medical device. Moreover, IMDRF [@IMDRF] defined the concept of *“Software as a Medical Device”* that is a software intended for use in different devices as medical functions that perform them without being part of a hardware medical device. This follows the classical role of the software engineering vision and software as a service paradigm. It should be noticed that this study considers that a software is a medical device when the functional properties of the software are enough to handle a clinical situation in which the software service is used as a whole medical device.

In the context of this paper, software is a key part, and middleware is a part of software stacks. As the importance of software increases 