Transcription of MEDICAL DEVICES Guidance document …
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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.
1 EUROPEAN COMMISSION DG HEALTH AND CONSUMER Directorate B, Unit B2 “Cosmetics and medical devices” MEDICAL DEVICES: Guidance document Classification of medical devices
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Classification, Labelling and Packaging, Annex, Classification, ANNEX 2 CLASSIFICATION AND LABELLING, Annex 2 CLASSIFICATION AND LABELLING SUMMARY TABLES, MEDICAL DEVICE REGULATION PRE-MARKET, Annex 2, Dangerous substances, Classification and labelling, Waste Classification Report, NEW FORMAT FOR SAFETY DATA SHEETS