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 regulations 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.