This document, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the new medical devices regulations and provides guidance on the application of classification criteria for software under Regulation (EU) 2017/745 –MDR and Regulation (EU) 2017/746 – IVDR.
The guidance also provides information related to placing on the market. The classification criteria (classification rules) are set out in Annex VIII of the Medical Devices Regulation (EU) 2017/745 (MDR) and Annex VIII of the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
The criteria specified in this document shall also apply to applications (commonly referred to as apps),may they be operating on a mobile phone, in the cloud or on other platforms