Proposed amendments to the medical devices Directives.
As 2005 came to a close, the European Commission issued its formal proposal for a Directive amending the medical devices Directives. This article discusses certain aspects of the proposed amendments and encourages readers to review them in their entirety.
Donawa
Maria
M
Donawa Consulting, Rome Italy. medonawa@donawa.com
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards; D012984:Software / Q000331:legislation & jurisprudence / Q000592:standards