What is an EU Authorised Representative? (E.A.R. / EU-AR)
The European Union requires any foreign manufacturer from outside of the European Union who intends to place their devices in any of the Member States to designate an authorised representative (EC REP) with a physical address within one of the Member States. Article 11 of the MDR states:
“where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer”
Under MDR and the IVDR, the EU Authorised Representative has more responsibilities than previously under the 'old' Directives. As per Article 11 of the MDR, the manufacturer and the EU Authorised Representative should agree the specific tasks in a mandate which the EU Authorised Representative will undertake on behalf of the manufacturer.
Under these new regulations, the EU Authorised Representative role is not a 'post-box' service. In fact, they are obliged to undertake certain compliance tasks which cannot be delegated or outsourced - see 'responsibilities' below.