title: 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.
authors: Université Lille Nord de France, Lille, France. sylvia.pelayo@univ-lille2.fr
authors: Sylvia
authors: S
authors: Pelayo
authors: Sabrina
authors: S
authors: Bras Da Costa
authors: Nicolas
authors: N
authors: Leroy
authors: Séverine
authors: S
authors: Loiseau
authors: Marie-Catherine
authors: MC
authors: Beuscart-Zephir
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D017408:Guidelines as Topic; D012984:Software / Q000331:legislation & jurisprudence* / Q000592:standards*