Medical device CE marking

Updated MEDDEV-guidance on software


European CommissionThe European Commission has updated the MEDDEV concerning Software. The document has been released on July 15, 2016.

The purpose of this document is to define the criteria for the qualification of stand alone software, when used in healthcare setting, as a medical device and the application of the classification criteria to such software.
This document only deals with stand alone software and provides some illustrative examples.
Software incorporated in medical devices is outside the scope of this guideline.
The criteria specified in this document apply also to mobile applications.

The document may be downloaded in our library