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.
3 Introduction The purpose of this document is to define the criteria for the qualification of stand alone software, when used in healthcare setting, as a
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