Authorized Representative Agreement Medical Device

Your European Representative serves as a link between you and the competent national authorities (Ministries of Health). In addition, your appointed representative will be appointed: after the UK`s exit from the European Union, EU and non-EU equipment companies may need a UK-based AR to be able to continue selling to the UK. In addition, UK-based companies may need an EU-based AR in order to continue selling in the EU. Contact us to find out more about brexit transition advisory services. 13) Is product liability covered by the Agreement on Professional Representatives? Why do I need a proxy? Medical device manufacturers established outside the EU must have an authorised representative in order to sell their products within the European Union. Also, the manufacturer places its name on the device. What is a proxy? A European authorised representative (also known as a RA or CE REP) is a legal person that acts as a link between a manufacturer established outside the EU and a competent national authority (Ministry of Health) within the EU. The authorised representative acts within the European Union on behalf of the manufacturer. They ensure that products sold on the EU market comply with European directives. Do you have any further questions about ARs for medical devices or directives modified due to new MDRs and/or Brexit? Certification Experts is ready to help.

14) Why do plenipotentiary agreements include a penalty clause in the event of an infringement committed by the manufacturer? CE marking of medical devices after Brexit Britain is no longer part of the EU. The following manufacturers must make adjustments in order to continue selling their medical devices within the EU: No, the name of the authorised representative remains on products already sold and still in use, which entails the continuation of certain obligations even after the termination of the contract. . . .

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