In January 2012, the European Commission published this guidance, MEDICAL DEVICES Guidance Document, Qualification and Classification of Stand Alone Software (aka MEDDEV 2.1/6). This document defines the criteria for the qualification of stand alone software, when used in a healthcare setting as a medical device, and the application of the classification criteria to such software.
Please, see the following sections for specifics:
- Section 2.1.1 and Figure 1: Decision tree on qualification of stand alone software as a medical device
- Section 2.1.2 and Figure 2: Decision tree on qualification of stand alone software as an in vitro diagnostic medical device
- Annex 1: Examples