Laws governing medical devices in the EU and their effect on free and open source software

“Council Directive 93/42/EEC came about as it was recognised
that the content and scope of the laws, regulations and
administrative provisions in force in the Member States with regard
to the safety, health protection and performance characteristics of
medical devices and certification of such devices are different.
This difference posed an actual threat to the free movement of good
and services with the Community. As such, the Directive sought to
harmonise national provisions with regard to the use of medical
devices.

“Software as a ‘medical device’

“As well as recognising various medical equipment and apparatus
as ‘medical devices’, the 1993 Directive also recognised the role
of software as potentially having important bearing on the proper
functioning of such medical equipment. Article 2(a) of the 1993
Directive stated that “‘medical device’ means any instrument,
apparatus, appliance […] including the software necessary for its
proper application intended by the manufacturer to be used for
human beings […]”.

“The amending Directive of 2007 sought to broaden the scope of
application of the legislation with respect to software…”

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