European Authorized Representative Services are required for non-EU manufacturers who want to place their medical devices, in vitro diagnostic medical devices, or other regulated products on the European market. The European Authorized Representative (EU Representative) acts as the manufacturer’s official representative in the European Union.
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Tasks performed by European Authorized Representative
Verify that the EU declaration of conformity and technical documentation has been drawn up and where applicable, that an appropriate conformity assessment procedure has been carried out by the Manufacturer.
Keep the technical documentation, the EU declaration of conformity and if applicable, a copy of any relevant certificate, including any amendments and supplements available for the competent authorities for at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
Comply with the registration obligations laid down in Art. 31 of (EU) MDR 2017/745 or Art. 28 of (EU) IVDR 2017/746 and verify that the manufacturer has complied with the registration obligations laid down in Art. 27 and 29 (EU) MDR 2017/745 or Art. 24 and 26 of (EU) IVDR 2017/746.
In response to a request from a competent authority, provide the 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.
Forward to the Manufacturer any request by a competent authority of the member state in which the EAR has its registered place of business for samples or access to a device and verify that the competent authority receives the samples or is given access to the device.
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. Terminate the Contract if the Manufacturer acts contrary to its obligations under this regulation.
The EAR will have permanently and continuously at their disposal at least one person responsible for regulatory compliance (PRRC) who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union.
Obligations of the Manufacturer
Must comply with all the requirements specified in Art. 10 (EU) MDR 2017/745 or Art. 10 (EU) IVDR 2017/746 regarding the general obligations of manufacturers.
Shall procure and always maintain during the term of the Contract a Product liability insurance covering the products placed on the European market. This liability insurance should include “EAR” as well. This insurance, however, will not protect “EAR” against liability that results from its unauthorized Activities, wrongful or negligent acts of omission, or breach of the Contract. The contract will not be valid if the annual EAR fee is not paid or the manufacturer does not meet this requirement.
Other Obligations of the EAR and Manufacturer
The European Authorized Representative shall provide all documentation and information that a market surveillance authority may require for market surveillance. The EAR shall rescind his contract with the Manufacturer if the latter does not provide him with access to the necessary information.
The Manufacturer shall keep the EAR informed in all matters that may be connected to the devices placed on the market in the EU. At the minimum, the exchange of information concerning paragraphs 10 to 12 hereunder shall be informed.
The Manufacturer shall be responsible for the content of the instructions for use and/or user’s manuals (hereinafter “IFUs”) and shall ensure that the English language IFUs are available to the EAR. If required by the local Competent Authorities, the manufacturer shall produce the German translation of the IFU at their own cost and responsibility since we are based in Germany. The manufacturer shall ensure that the required local language IFUs are provided to the customers.
The Manufacturer shall establish necessary procedures to prepare, maintain and update technical documentation including the declaration of conformity for the products set out in Appendix A to be able to comply with the MDR/IVDR requirements.
The Manufacturer shall transfer the agreed Technical Documentation and Declaration of Conformity to the EAR upon request. The Manufacturer shall have the responsibility to provide to the EAR any additional documentation as required by the Competent Authority or Notified Body. The EAR shall provide a copy of the contract to the competent authority upon request.
Conclusion
European Authorized Representative service for medical devices and in-vitro diagnostic device manufacturers seeking to enter the European market from any non-European countries. We are medical device regulatory experts and persons responsible for regulatory compliance. I3CGLOBAL have the complete solution for all your regulatory needs.