EC declaration of conformity.
The CE-marking procedure requires that manufacturers draw up a written declaration of conformity before placing their products on the market. However, some companies do not realize that this is a requirement for all devices. Also, there is no detailed information concerning the contents and format of the EC declaration of conformity in the medical device Directives or in EC guidance documentation. This article will discuss some important aspects of the EC declaration of conformity and some of the guidance that is available on its contents and format.
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Donawa and Associates Ltd., Rome, Italy.
D004864:Equipment and Supplies / Q000592:standards; D005060:Europe; D017408:Guidelines as Topic; D007603:Jurisprudence; D011786:Quality Control