title: IVD authorized representatives.
abstract: Under the In Vitro Diagnostic (IVD) Directive, a manufacturer of IVD medical devices located outside the European Economic Area must designate an Authorized Representative before placing those products on the European market. This article discusses the responsibilities of Authorized Representatives under the IVD Directive and some of the important differences of the role as it is defined in the Medical Device Directive.
authors.affiliation: donawa@srd.it
authors.forename: Maria E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D019719:Diagnostic Equipment / Q000145:classification / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards; D005062:European Union; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D017408:Guidelines as Topic; D038622:Internationality / Q000331:legislation & jurisprudence*; D007603:Jurisprudence; D010934:Planning Techniques; D011358:Product Surveillance, Postmarketing / Q000592:standards