European requirements for product returns.
Considerable uncertainty exists regarding European requirements for withdrawing a product from the market because of product performance problems that are not related to serious health risks or death. This article discusses the requirements for product returns or other related actions that are outside the scope of the recall notification requirements defined in the medical device Directives.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards*; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*