title: Scope of the European Medical Device Directives.
abstract: Can a product that incorporates nonviable human tissue be regulated as a medical device in Europe? Is a product that includes viable tissues or cells of animal origin regulated as a medical device? Is a product that incorporates a human blood derivative regulated as a medical device? This article discusses the scope of the medical device Directives and the regulatory status of products that are excluded.
authors.affiliation: Donawa Consulting, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D020811:Biomedical Technology; D018795:Device Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation