European Authorized Representative (EAR) for EU Registration

European Authorized Representative (EAR) for EU Registration is a requirement according to EU MDR and EU IVDR for any Non-European manufacturer planning to commercially distribute or market their product in the European Union. The EAR is required to be located within the EU or be legally established in the EU.

An EAR serves as a liaison between the manufacturer and the Competent Authority. If there are any incidents occurring from the use of the manufacturers device or any Field Safety Corrective Action (FCSA) reporting, they assist in whatever way possible and co-operate with the manufacturers. They maintain the latest or the most current version of the manufacturers Technical file for any inspection by the Competent Authorities. They also provide a EU registered address to be used on the product label. They help in keeping track of the registration of the manufacturer, importer etc and helps keep them updated.