EU Authorised Representative
The EU Authorised Representative (EUAR) role for medical devices has existed since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017. It was a requirement of their predecessors the medical device directives.
Since the MDR and IVDR Regulations were introduced, the role of the EUAR has become wider in scope and responsibilities.
Article 11 MDR and IVDR
Article 11 of the MDR and the IVDR sets out the requirements and responsibilities of an EUAR. This includes the following:
Non-member state-based manufacturers:
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 Authorised Representative.
Responsibility:
If the manufacturer is not based in a Member State and fails to meet the obligations in Article 10 (Manufacturers Responsibilities), the Authorised Representative is legally liable for defective devices, jointly and equally with the manufacturer.
An EUAR ending its mandate must immediately inform the Competent Authority of its Member State and, if applicable, the Notified Body involved in the device’s conformity assessment, along with the reasons for termination.
Changing an Authorised Representative:
The agreement between the manufacturer and authorised representative must clearly define the details of changing the representative. It should cover:
- The termination date of the outgoing representative’s mandate and the start date of the incoming representative’s mandate.
- The last date the outgoing representative can appear in the manufacturer’s information, including promotional material.
- The transfer of documents, including confidentiality and ownership rights.
- The outgoing representative’s obligation to forward any complaints or reports from healthcare professionals, patients, or users about suspected device incidents after the mandate ends.
Mandate:
The designation forms the Authorised Representative’s mandate and is valid only when the EUAR accepts it in writing. It applies to all devices within the same generic device group.
The EUAR carries out the tasks outlined in the mandate agreed with the manufacturer and must provide a copy of the mandate to the competent authority upon request.
Mandated Tasks:
- Verify that the manufacturer has prepared the EU declaration of conformity and technical documentation, and if applicable, conducted the proper conformity assessment procedure.
- Keep a copy of the technical documentation, EU declaration of conformity, and, if applicable, the relevant certificate (including amendments) available for competent authorities for the period stated in Article 10(8).
- Fulfill the registration obligations in Article 31 and ensure the manufacturer has complied with Articles 27 and 29.
- Provide all necessary information and documentation to a Competent Authority, in the official Union language required by the Member State.
- Forward any requests from the competent authority for device samples or access, and ensure the authority receives the samples or access.
- Work with competent authorities on any preventive or corrective actions to address device risks.
- Immediately notify the manufacturer about complaints or reports from healthcare professionals, patients, or users regarding suspected device incidents.
- End the mandate if the manufacturer fails to meet its regulatory obligations.
How can Patient Guard help you?
Patient Guard, through its subsidiary Patient Guard Europe UG in Neuhausen auf den Fildern, Germany, provides Authorised Representative services. We have assisted many medical device manufacturers outside the EU in registering their devices in Europe. To learn more about how Patient Guard can help register your medical device in the EU, click the button below.
