.png "qadvis_web-300x138_180925")
.png "qadvis_web-300x138_180925")
✿ A European Authorized Representative may also be known as Authorized Representative (AR)
✿ European Authorized Representative (EAR)
✿ EC REP
✿ CE REP
✿ EU REP
✿ EUAR
✿ All of these mean the same; EU Authorized
Representative.
✿ as per the requirements from Article 11 of EU MDR 2017/745 and IVDR 2017/746.
✿ Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer
designates a sole authorized representative.
✿ Manufacturers outside the EU/EAA must have an authorised representative within the EU/EEA in order for devices to be placed on the market within the EU/EEA. The authorised representative’s responsibility must be regulated
in a mandate from the manufacturer. An authorised representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside
the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations. Responsibilities include but not limited to:
✿ The authorised representative must be a point of contact for authorities and users within the EU/EEA for the devices in question
✿ The authorised representative has the legal responsibility for defective devices
on an equal basis with the manufacturer
✿ 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
✿The AR shall perform the tasks specified in the mandate agreed between it and the manufacturer.
✿ Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries
of Health). Additionally, your appointed representative will:
✿ Assist with certain device registrations, as required.
✿Be identified on your product labeling throughout Europe.
✿Make a current copy of your
Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request.
✿ Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and
your distributors.
✿The role of a European Authorized Representative is both varied and challenging. The main duties include, but are not limited to, the following:
✿Providing a registered address within the European
Union
✿Keeping all technical documentation available for inspection by the European Authorities
✿ Completing notifications to European Authorities
✿ Completing any registrations to national databases
✿ Taking care of any incident reporting
✿ Representing the manufacturer towards the European Commission, Authorities and Notified
✿ Safeguarding and ensuring compliance with constant regulatory updates
✿ Consulting
on European Regulations
