Drug-device products.
A drug-device product is generally regulated by the Medical Device Directive or by the Medicinal Product Directive. But for some types of product, cross-references are made to specific requirements in both Directives. This article provides an overview of the regulation of these products and the conformity assessment procedures that are required.
Tarabah
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TUV Product Service GmbH Paris, France.
Taxacher
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D001672:Biocompatible Materials / Q000592:standards*; D016503:Drug Delivery Systems / Q000592:standards*; D004335:Drug and Narcotic Control; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006801:Humans
D001672:Biocompatible Materials