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A recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare.
McHugh, M., McCaffery, F., Casey, V. :How Amendments to the Medical Device Directive Affect the Development of Medical Device Software. European Systems and Software Process Improvement and Innovation Conference, 2011, EuroSPI Roskilde, Denmark