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Ivd guide EuropeAid D SV CY Assessment and administration capacity building for the harmonisation with the New Approach directives GUIDE to the implementation of DIRECTIVE EC on IVD In Vitro Diagnostic Devices CGuide on IVD Directive EuropeAid D SV CY Thi

EuropeAid D SV CY Assessment and administration capacity building for the harmonisation with the New Approach directives GUIDE to the implementation of DIRECTIVE EC on IVD In Vitro Diagnostic Devices CGuide on IVD Directive EuropeAid D SV CY This Guide was printed with funds of the EuropeAid D SV CY project ??Assessment and administration capacity building for the harmonisation with the New Approach directives ? The views expressed in this publication do not necessarily re ect the views of the European Commission or the Cyprus Ministry of Commerce Industry and Tourism ? Republic of Cyprus Nicosia May CGuide on IVD Directive EuropeAid D SV CY INTRODUCTION This information is intended as general guidance and should not be regarded as an authoritative statement of the law Manufacturers and others should not rely on this information but should consult the legislation referred to making their own decisions on matters a ?ecting them in conjunction with their lawyers and other professional advisers What is a medical device A series of three Directives regulating the safety and marketing of medical devices throughout the European Union started to come into e ?ect from January For the purposes of the Directives a medical device is de ?ned as any instrument apparatus appliance material or other article whether uses alone or in combination including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of ? diagnosis prevention monitoring treatment or alleviation of disease ? diagnosis monitoring treatment or alleviation of or compensation for an injury or handicap ? investigation replacement or modi ?cation of the anatomy or of a physiological process ? control of conception and which does not achieve its principal intended action in or on the human body by pharmacological immunological or metabolic means but which may be assisted in its function by such means Why do we need the directives Before the introduction of the medical devices Directives each Member State in the European Union would control the safety and marketing of medical devices on its territory in di ?erent ways The Directives bene ?t manufacturers by harmonising controls within a single system and avoid the need for manufacturers having to comply with or di ?erent sets of rules Purchasers and users can also be reassured that devices manufactured anywhere in the Union should meet common standards of performance and safety The Directives bene ?t patients and users by setting out essential requirements that products must meet These make it clear that devices must not compromise the health or safety of the patient user or any other person and that any risks associated with the device are compatible with patient health and protection Any side e ?ects must be acceptable when weighed against the intended performance of a device Devices meeting these requirements generally carry the CE mark to show that they comply THE DIRECTIVES THE ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE This ?rst Directive covers all powered implants or partial implants that are