Review of the Medical Device Directive.
An effective evaluation of the functioning of the Medical Device (MD) Directive is of the utmost importance and has global significance. This article discusses the official review of the MD Directive, its conclusions, and some of the more important activities resulting from the review.
Donawa
Maria
M
Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards*; D005062:European Union; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*