IVD authorized representatives.
Copyright policy )IVD authorized representatives.
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.
Jurisprudence, Internationality, Equipment and Supplies, Commerce, Device Approval, Product Surveillance, Postmarketing, Guidelines as Topic, European Union, Guideline Adherence, Planning Techniques, Diagnostic Equipment
Jurisprudence, Internationality, Equipment and Supplies, Commerce, Device Approval, Product Surveillance, Postmarketing, Guidelines as Topic, European Union, Guideline Adherence, Planning Techniques, Diagnostic Equipment
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