title: Standalone medical device software: The evolving regulatory framework.
abstract: The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.
authors.affiliation: a Medical Physics and Clinical Engineering .|b NIHR Devices for Dignity Healthcare Technology Co-operative at Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital , Glossop Road , Sheffield , S10 2JF , UK .|c School of Health and Related Research (ScHARR), University of Sheffield , Regent Court, 30 Regent Street , Sheffield S1 4DA , UK .
authors.forename: Avril D
authors.initials: AD
authors.lastname: McCarthy
authors.affiliation: d Medical Physics Group, Department of Cardiovascular Science , The Medical School, University of Sheffield , Beech Hill Road , Sheffield , S10 2RX , UK , and.|e INSIGNEO, Institute for in silico Medicine, University of Sheffield, Room F19, The Pam Liversidge Building, Sir Frederick Mappin Building, Department of Mechanical Engineering , The University of Sheffield , Mappin Street , Sheffield S1 3JD , UK.
authors.forename: Patricia V
authors.initials: PV
authors.lastname: Lawford
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000145:classification*; D005060:Europe; D033161:Government Regulation; D038622:Internationality; D012984:Software / Q000145:classification / Q000331:legislation & jurisprudence* / Q000639:trends*
keywords: Healthcare apps; medical device; regulations; standalone software