« Authorized Representative means any natural or legal person established in the Community who, explicitly designated by the Manufacturer, acts and may be addressed by Authorities and Bodies in the Community instead of the Manufacturer with regard to the latter’s obligations under this directive ».
Under the Article 11 of the Regulations (EU) 2017-745 & 2017-746, the authorised representative shall perform at least the following tasks in relation to the devices:
(a) verify 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;
(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competentauthority receives the samples or is given access to the device;
(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
In addition, where the manufacturer has not complied with its obligations under the MDR and the IVDR, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.This is the reason why the civil liability insurance of the Manufacturer shall cover Authorized Representative for corporal, material and immaterial risks.
An ISO Certified Quality System, a high competency in European Regulatory Affairs, a very good knowledge of medical devices and hospital environment, and respectable relationship with European and National competent Authorities are necessary to fulfil the responsibility of Authorized Representative.