Scope of the European Medical Device Directives.
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.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D020811:Biomedical Technology; D018795:Device Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation