The Authorized Representative for extra EU Manufacturers
“Authorized Representative” means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.
The regulations concerning medical devices and in vitro diagnostic medical devices require that all the extra EU Manufacturers design a European authorized representative (EC REP), which must appear on the label and must be registered into the EUDAMED database.
BREXIT and SWIXIT
All the EU Manufacturers based in Great Britain or in Switzerland must design a European authorized representative too, as a consequence of BREXIT and SWIXIT (beforehand Swiss Manufacturers did not design an EC REP thanks to the mutual recognition agreements).
This requirement does not apply only to products compliant to the new Regulations, but also to the so-called “legacy devices” and “legacy products under IVDR”, i.e. products on the market by virtue of the old Directives.
The EC REP plays a key role for Manufacturers who wants to enter the EU market, excluding the already mentioned minimum requirements: indeed, the EC REP is obliged to maintain the technical documentation of the Medical Device in order to reply to any requests from the Competent Authorities, including possible issues related to the safety of the products.
Moreover, one of the main news, introduced by the Regulation EU 2017/745 and 2017/746, is that the EC REP is liable for defective devices on the same basis as the Manufacturer.
The best way to meet the requirement is to rely on an external specialist, taking into account that the assumption of the role of EC REP comes with several and onerous responsibilities, if the Manufacturer has not an office based in the EU territory, as an example, or if the Company staff does not possess adequate expertise.
Di Renzo Regulatory Affairs can either assume the role of authorized representative for Manufacturer based outside the EU or provide its consultancy to companies acting as authorized representative by means of the following services:
- performing Manufacturers and product registrations into the EUDAMED database
- managing incident reporting according to the applicable European requirements
- being the contact point for European Competent Authorities
- cooperating with European Competent Authorities on any corrective action that may be necessary to eliminate the risks posed by devices
- immediately informing the manufacturer of any complaints or reports from healthcare professionals, patients and users regarding suspected incidents related to a device for which the EC REP has been designed.
