Transcription of Medical Device Directive 93/42/EEC CE-Marking …
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Medical Device Directive 93/42/EEC CE-Marking …
Medical Device Directive 93/42/EEC . CE-Marking What Manufacturers Need to Know & Do By: Yvonne Halpaus QNET LLC. Conformity with Medical Device Directive 93/42/EEC . is mandatory all devices that fit the definition of a Medical Device ' and its This Directive is in the process of being replaced by a Regulation. Approval of the Regulation remains pending. Before starting the compliance immunological or metabolic means, but which may process a manufacturer needs to be be assisted in its function by such means;. able to answer the following four or basic questions: b) accessory' means an article which whilst not 1) Does the Device meet one of following 2 being a Device is intended specifically by its definitions?
Copyright © 2015 QNET LLC – All Rights Reserved- Version 1 Page 3. e) Essential requirements may include biocompatibility, flammability, EMC/LVD,
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