What does the EU Authorized Representative do?
There are quite a few tasks that EU Authorized Representative is obliged to perform.
These tasks include verification that the EU Declaration of Conformity and Technical Documentation have been drawn up, checking that a conformity assessment procedure has been carried out for higher risk class devices. They are also the gate keepers in EUDAMED, being responsible for verifying that the non-EU manufacturer has complied with the EU registration obligations.
On top of these EU Authorized Representative is responsible for the Competent Authority correspondence for providing them with all the information and documentation necessary to demonstrate the conformity of a device. This is to be done in a language determined by the Member State concerned.
Additionally, EU Authorized Representative forwards to the manufacturer any request by a Competent Authority for samples, or access to a device and verifies that the Competent Authority receives the samples or is given access to the device.
In addition, EU Authorized Representative shall cooperate with the Competent Authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices, and in informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents
Last, it is to be noted that the EU Authorized Representative is legally liable for defective devices on the same basis as, and jointly with, the manufacturer.