Transcription of MEDICAL DEVICES Guidance document …
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MEDICAL DEVICES Guidance document …
1 EUROPEAN COMMISSION DG HEALTH AND CONSUMER Directorate B, Unit B2 Cosmetics and MEDICAL DEVICES MEDICAL DEVICES : Guidance document - classification of MEDICAL DEVICES MEDDEV 2. 4/1 Rev. 9 June 2010 GUIDELINES RELATING TO THE APPLICATION OF THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES Foreword The present MEDDEV is part of a set of guidelines relating to questions of application of EU Directives on MEDICAL DEVICES . They are not legally binding. Only the European Court of Justice can give an authoritative interpretation of Community Law.
4 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 available.
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