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Regulating Medical Software Challenges at European and International Levels
This is an opportunity to learn more about regulations applicable to software
used in medical practice, with a focus on the pre-market aspects and support of
European standards: what regulation is applicable to which software, and how
compliance with that regulation can be achieved. The amendment to the medical
devices directives by 2007/47/EC, in force since 21 March 2010, recognized that
standalone software can be a medical device and thus regulated. Since that date,
however, there is some uncertainty as to which software actually IS within the
scope of the directive.
Last modified 12/09/11