COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment. The document includes a clear definition of what software includes, which is a wide range of items. Refer to the footnotes for some details that refer back to the MDD.
COCIR Issues Flowchart to determine if Software = Med Dvc per MDD