What is the definition of the “Authorized Representative”?
In the Medical Device Directive (93/42/EEC), there is no definition of the Authorized Representative. Only when the IVD Directive (98/79/EC) was published in December of 1998, did the following ‘official’ definition become available; authorized representative means any natural or legal person established in the community who, explicitly designated by the manufacturer, acts and may be addressed by the authorities and bodies in the community instead of the manufacturer, with regard to the latters obligations under the medical device directive 93/42/EEC or in vitro diagnostic directive 98/79/EC. Why is an Authorized Representative necessary? If you “Place Medical Devices on the Market” in Europe and your Manufacturing facility is located outside Europe, then you must have an Authorized Representative within Europe, to communicate and deal with Competent Authorities on your behalf. (Article 21- IVD Directive amendment to MDD 93/42/EEC)) Our Authorized Representative Policy is.
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