EC Medical Device Guidance: Qualification and Classification of Stand Alone Software, 1/12

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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