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  • 1.  EU MDR Importer Agreement

    Posted 02-Dec-2020 13:35
    Hi Reg Experts-
    Do any of you have template/suggestion for drafting the EU MDR Importer agreement for a manufacturer outside of EU? Any suggestion is greatly appreciated.

    Thanks in advance,
    Ritam

    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
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  • 2.  RE: EU MDR Importer Agreement

    Posted 02-Dec-2020 14:01
    An effective EU MDR Importer Agreement entails not only assuring proper attention to the requirements of EU MDR Article 13, but also assuring that associated general business arrangements are established between the parties of the Agreement.  I've been helping manufacturers outside the EU write their EU MDR Importer Agreements and would be glad to help.  Feel free to contact me offline if you'd like to discuss further.  kevin@complianceacuity.com

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: EU MDR Importer Agreement

    Posted 03-Dec-2020 04:23
      |   view attached
    Dear Ritam

    There is a very good Factsheet on this topic issued by the European Commission (also attached as PDF).
    https://ec.europa.eu/docsroom/documents/33862

    Please also consider that if you are not based in the EU that you will need to have an EU Authorised Representative (AR). The relationship between the AR and the importer should be considered in any contractual agreement. Please consult the MDR and this fact sheet with regards to the roles and responsibilities of both. 
    Please feel free to contact me. 

    Best Regards,
    Stephanie

    Stephanie Grassmann, Managing Director

    MedTechXperts GmbH
    Jungenbergstrasse 7
    CH-5023 Biberstein
    Switzerland

    Mobile: +41 (0)79 287 1252
    sgrassmann@medtechxperts.com

    info@medtechxperts.com
    http://www.medtechxperts.com

     

    Expediting Market Access & Ensuring the Success of Your Medical Device



    ------------------------------
    Stephanie Grassmann
    Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
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    Attachment(s)

    pdf
    FS_MD_Importers distributors_EN.pdf   330 KB 1 version
    Original Message


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