GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYThis Guide was printed with funds of the EuropeAid /114385/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 reflect the views of the European Commissionor the Cyprus Ministry of Commerce, Industry and Tourism.© Republic of Cyprus, Nicosia, May 2004
Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYINTRODUCTIONThe information in this guide is intended as general guidance and should not be regarded as anauthoritative statement of the law. Manufacturers and others should not rely on this information but shouldconsult the legislation referred to, making their own decisions on matters affecting them in conjunctionwith 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 theEuropean Union started to come into effect from 1 January 1993.For the purposes of the Directives, a medical device is defined as:"any instrument, apparatus, appliance material or other article, whether uses alone or incombination, including the software necessary for its proper application intended by themanufacturer 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 orhandicap,• investigation, replacement or modification of the anatomy or of a physiological process,• control of conceptionand which does not achieve its principal intended action in or on the human body bypharmacological, immunological or metabolic means, but which may be assisted in its function bysuch means".WHY DO WE NEED THE DIRECTIVES?Before the introduction of the medical devices Directives, each Member State in the EuropeanUnion would control the safety and marketing of medical devices on its territory in different ways.The Directives benefit manufacturers by harmonising controls within a single system and avoidthe need for manufacturers having to comply with 15 (or 25) different sets of rules. Purchasersand users can also be reassured that devices manufactured anywhere in the Union should meetcommon standards of performance and safety.The Directives benefit patients and users, by setting out essential requirements that productsmust meet. These make it clear that devices must not compromise the health or safety of thepatient, user or any other person, and that any risks associated with the device are compatiblewith patient health and protection. Any side effects must be acceptable when weighed against theintended performance of a device. Devices meeting these requirements generally carry the "CE"marking to show that they comply.THE DIRECTIVESTHE ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVEThis first Directive covers all powered implants or partial implants that are left in the human body. Heartpacemakers are the most common example of powered implants.
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GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

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