What are the Roles & Responsibilities of an EAR

Roles & Responsibilities of an EAR

✿ The AR shall perform the tasks specified in the mandate agreed between it and the manufacturer.
✿ The AR verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer (MRD/IVDR Article 11(3)(a)).
✿ The AR must also keep copies available of all documents and make them accessible to authorities on request. This includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements (MDR/IVDR Article 11(3)(b)).
✿ The AR will have to verify that the manufacturer has registered the requested information in EUDAMED (MDR/IVDR Article 11(3)(c)).
✿ An authorized representative will have to cooperate with authorities on preventive and corrective actions and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
✿ The authorised representative will be liable for defective devices together with the manufacturer, if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU (MDR/IVDR Article 11(5)).
✿ The authorised representative should terminate the mandate if the manufacturer acts contrary to its obligations (MDR/IVDR Article 11(3)(h)).
✿ In such situations, the authorised representative shall immediately inform the Member State in which it is established and, where applicable, the Notified Body involved in the conformity assessment of the device, of the termination and the reasons behind it