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What is a European Union Authorized Representative? Medical device manufacturers based outside of the European Union must, by law, appoint an EU Authorized Representative (EUAR). Without it, any CE mark that has been granted becomes invalid. In the case of adverse incidents, the EUAR should be the primary contact, managing information flows and requests between the legal manufacturer and regulatory authority. Choose High Edge Authorized Rep. Advice you can trust. Practical, on the ground support.

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As of 21 March 2010. EEA European Authorised/Authorized Representative. Must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Medical Devices and IVD. In Vitro Diagnostic Medical. Other EEA authorities by world-leading CE Marking. Specialists based in London/UK. Click here to get FREE Guide. You export to Europe? UL mark; China Compulsory Certification- CCC Mark. China RoHS compliance and solutions, etc. How can Wellkang help you? Wellkang's m...

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