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  • 1.  European Authorised Representative

    Posted 17-Feb-2020 04:41

    Hi All. 

    Please can people share their experiences / recommendations and cost for appointing a European Representative? 

    I have performed some searches and unearthed a number of companies but I do not want to contact each one individually, I would like to rule out the good, bad and ugly before I go forward. 

    Thanks
    James



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    James
    Head of QARA
    UK
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  • 2.  RE: European Authorised Representative

    Posted 17-Feb-2020 09:19
    I used to recommend the EAAR members (http://www.eaarmed.org/) as the primary authorized representatives to consider. However, some of the members are no longer offering AR services. Emergo is probably the largest AR, but the quality of the review and the support services the AR provides are excellent indicators of whether the AR is worthy of selection. For example, https://medimark-europe.com/ offers a spreadsheet on their website explaining how to complete the new MIR form required for vigilance reporting. A good AR will review your procedures and identify gaps. Treat your selection process like the selection of a consultant, and don't shop based upon price.

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    Rob Packard
    Shrewsbury VT
    United States
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    Original Message


  • 3.  RE: European Authorised Representative

    Posted 18-Feb-2020 05:30
    And remember the EC REP, Authorised Representative, needs to 'keep available a copy of the technical documentation' so they need full and permanent access to technical documentation; consider any proprietary or confidential aspects.  If there is an issue, the Competent Authority/Member State will contact your EC REP asking them to surrender the technical documentation for review - and they will expect it immediately.  Make sure to read the obligations under Article 11 and as Rob suggested question the AR during the selection on how they manage these activities, if they have their own internal procedures, and resources to manage communications with regulatory authorities.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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