Regulating human-tissue products in France.
The absence of a pan-European regulatory framework for medical devices incorporating human tissues is causing difficulties for the growing number of manufacturers of these products. France has implemented strict legislation in this area and is spearheading an effort for Member States to adopt similar measures. This article looks at the status of French regulations, which form the basis of its recent proposal to the European Commission for a new Directive on human tissues.
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MedPass International, Paris, France.
D004864:Equipment and Supplies / Q000592:standards*; D004992:Ethics, Medical; D005602:France; D006801:Humans; D011640:Public Policy; D012449:Safety; D014015:Tissue Banks / Q000331:legislation & jurisprudence*; D014020:Tissue Extracts / Q000592:standards
D014020:Tissue Extracts