Transcription of MEDICAL DEVICES: Guidance document
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MEDICAL DEVICES: Guidance document
EUROPEAN COMMISSION. DG ENTERPRISE. Directorate G. Unit 4 - Pressure Equipment, MEDICAL devices , Metrology MEDICAL devices : Guidance document MEDDEV July 2001. GUIDELINES FOR THE classification . OF MEDICAL devices . The present Guidelines are part of a set of Guidelines relating to questions of application of EC- Directives on MEDICAL devices . They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document .
- 3 - 1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures
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