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  • 1.  EU Authorized Representative

    Posted 11-Jun-2019 10:07
    Hi 

    I have a question regarding the EU Authorized Representative for a Medical device.
    What is the process to authorize the representative and what regulation do I find the requirement?

    With all of the recent changes I want to make sure I have the most recent information.

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    Karen McQueen RAC
    Staff Quality Engineer, Investigations
    Raleigh NC
    United States
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  • 2.  RE: EU Authorized Representative

    Posted 11-Jun-2019 17:14
    Karen,

    If your company does not have a physical location in Europe, you are required to appoint an EC REP or Authorized Representative (AR) to be you legal Representative who serves as a liaison between you and the national Competent Authorities (CA). The AR will have to fulfill tasks defined in Article 11(3) of the regulation. First of all, the AR must accept your mandate in writing. Secondly, the AR shall at least be representing the same generic device group (kindly refer to GMDN codes for grouping). Most importantly, don't choose one that is in the UK for the reason that we all know. Find someone who is well qualified to handle regulatory issues as you will need to place their name and address on your device label. At a minimum, an AR must be able to handle incident reporting, product recalls, complaint handling, and post-market feedback.

    Under the new MDR, the AR will take on more risk and liability. On the Regulation, an AR, an importer, a distributor are also considered "Economic Operators" (EO). As such, your AR should be independent and neutral so I don't recommend appointing a distributor as your AR. Here is a list of EC REP and a checklist on how to choose an AR. Good luck!




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    Jo Huang RAC
    Sr. Regulatory Affairs Specialist
    Athens TX
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    Original Message


  • 3.  RE: EU Authorized Representative

    Posted 11-Jun-2019 18:23

    Because you are asking about a medical device, I infer the question is about either the MDD or the MDR.  Because you ask about recent changes, I infer you mean the MDR.

    The MDR includes the concept of economic operator, which includes the device manufacturer and various parties in the manufacturer's distribution channel.

    If you are a manufacturer outside the EU, then you must have a Authorized Representative, AR, inside the EU. The AR is your legal representative.

    The AR is a supplier who performs an outsourced process. Follow the requirements in ISO 13485:2016, 7.4.1 to evaluate and select the AR. The evaluation criteria include the items in Art. 11(3), qualification of the person responsible in Art. 15(6), and the ability to satisfy the liability requirements in Art. 11(5), see Art. 10(16).

    Follow the requirements of ISO 13485:2016, 7.4.2 for purchasing information. This will include the written mandate in Art. 11(3) and the quality agreement (which could be the same document).



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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