This document, which primarily targets Medical Device Software (MDSW) manufacturers,
provides guidance on:
- the criteria for the qualification of software falling within the scope of the Medical
Device Regulations, including Medical Device Artificial Intelligence (MDAI), - the application of the classification criteria under those regulations3 to MDSW and
- information related to placing on the market MDSW.
The criteria specified in this document also applies to applications (commonly referred to as
‘apps’), regardless of their location i.e. may they be operating on a mobile phone, on the
cloud or on other platforms.
Note: the term “standalone software” which was used under the Medical Devices
Directives, is no longer used in the context of the Medical Device Regulations. The rationale
of the change is that software should be qualified and classified depending on its intended
purpose uniquely, regardless of its location (i.e. embedded, operating on a platform, on the
cloud, etc.)…
