Transcription of MEDICAL DEVICES Guidance document - …
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MEDICAL DEVICES Guidance document - …
EUROPEAN COMMISSION DG HEALTH AND CONSUMER Directorate B, Unit B2 Health Technology and Cosmetics _____ MEDICAL DEVICES : Guidance document - Qualification and Classification of stand alone software _____ GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES Foreword The present guidelines are part of a set of guidelines relating to questions of application of the EU legislation on MEDICAL DEVICES . They are legally not binding. The guidelines have been carefully drafted through a process of consultation of the various interested parties (Competent Authorities, Commission services, industry and Notified Bodies in the MEDICAL device sector) during which intermediate drafts were circulated and comments were taken up in the document where appropriate.
5 ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic
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