Refurbished medical equipment.
The European medical device Directives apply to persons who fully refurbish medical equipment and place these products on the market under their own names. However, the Directives do not address any other type of refurbishing. This article discusses the European and United States (US) regulatory requirements for refurbishers, raises some questions concerning these requirements, and discusses a US advance notice of proposed rule making on refurbishers.
Donawa
M E
ME
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards*; D004389:Durable Medical Equipment / Q000592:standards*; D017743:Equipment Reuse / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans; D011050:Policy Making; D014481:United States; D014486:United States Food and Drug Administration