MDCPartners is an experienced European Authorized Representative – EC REP – for the IVD 98/79/EC and MD 93/42/EC directives.
The European directives enforce the use of an Authorized Representative for manufacturers based outside the European Union.
The EC REP is the interlocutor between the manufacturer and the European Competent Authorities. In the case of a reportable incident with a device, the European Authorized Representative will be the first organization to be approached by the Competent Authority.
As EC REP, MDCPartners co-reviews the technical file and labeling, co-ordinates notification and accompanies the post-marketing responsibilities of the manufacturer
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