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Software as a medical device: regulatory critical issues.

Abstract : The revised Medical Device Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medical device. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medical device. This paper identifies some issues at stake and discusses them.
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Submitted on : Wednesday, October 5, 2016 - 3:57:48 PM
Last modification on : Wednesday, March 23, 2022 - 3:51:13 PM


  • HAL Id : hal-01376784, version 1
  • PUBMED : 23388310


Sylvia Pelayo, Sabrina Bras da Costa, Nicolas Leroy, Séverine Loiseau, Marie-Catherine Beuscart-Zephir. Software as a medical device: regulatory critical issues.. Studies in Health Technology and Informatics, IOS Press, 2013, pp.337-42. ⟨hal-01376784⟩



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