Regulatory Open Forum

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  • 1.  EU Authorized Rep

    Posted 15-Nov-2017 17:32
    Hello, Has anyone elected a EU Authorized Rep that they would recommend? Positive or negative reviews welcome...
    Thank you


  • 2.  RE: EU Authorized Rep

    Posted 15-Nov-2017 17:39
    I worked in the past with both MDI - Europe and CE partner 4U (for class <g class="gr_ gr_155 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="155" data-gr-id="155">IIa</g> and IIb medical devices). Both were OK.

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    Tal Bresler, PhD.RAC

    Toronto, On, Canada
    tal.bresler@gmail.com
    https://www.linkedin.com/in/talbresler/
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    Original Message


  • 3.  RE: EU Authorized Rep

    Posted 16-Nov-2017 13:33
    We use MDSS, I very much appreciate their service.

    MDSS GmbH

    Schiffgraben 41; 30175 Hannover; Germany

    Tel.: +49 511 6262 8630; Fax: +49 511 6262 8633; www.mdss.com




    Original Message


  • 4.  RE: EU Authorized Rep

    Posted 17-Nov-2017 03:59
    You should use a member of EAAR (European Association of Authorised Representatives), if at all possible, Robin. These companies offer professional services and the Association represents the interests of ARs and their clients with the European Commission and other governmental bodies. The EAAR website can be found here: www.eaarmed.org.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
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    Original Message


  • 5.  RE: EU Authorized Rep

    Posted 17-Nov-2017 10:52
    ​One AR I have experience with is

     MediMark® Europe Sarl

    11 rue Emile Zola. BP 2332

    38033 Grenoble Cedex 2 - France



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    David Geraghty
    Director QA & RA
    Redmond WA
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    Original Message


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