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  • 1.  CE mark acceptance outside the European Union

    Posted 18-Mar-2021 07:02
    Hi all,

    does anyone of have a list, in which countries worldwide the European CE-mark (MDD) is accepted as market access or CE-marked Devices have low regulatory hurdles?

    Thank you for your help!

    Regards,

    ------------------------------
    Britta Cyron
    Bochum
    Germany
    ------------------------------


  • 2.  RE: CE mark acceptance outside the European Union

    Posted 19-Mar-2021 06:24
    Hello Britta,

    I am not sure you will find a complete list anywhere and many consulting companies maintain this as part of the services they offer - especially those doing registration services or Sponsor/in-country representation.  Off the top of my head these are countries like Australia, South Africa, Turkey.  Though keep in mind often a CE Mark as you say just lowers the regulatory hurdle to get through regulatory registration or submissions, it often does not replace or allow direct market entry.  There are some countries which do just accept CE Mark to sell in the country, though these are usually ones without any substantial regulatory requirements.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: CE mark acceptance outside the European Union

    Posted 19-Mar-2021 09:33
      |   view attached
    Here is my list.



    ------------------------------
    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
    ------------------------------

    Attachment(s)

    doc
    Countries that require CE Mark.doc   28 KB 1 version
    Original Message


  • 4.  RE: CE mark acceptance outside the European Union

    Posted 20-Mar-2021 15:16
    Hello,
    The ones I know: Ukraine, Armenia (until 2022), Azerbaijan. Also Mongolia.

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 5.  RE: CE mark acceptance outside the European Union

    Posted 22-Mar-2021 03:25

    Thank you all for your help!
    To the countries you alredy mentioned I can add:
    • Hongkong
    • Georgia
    • Chile
    Richard,
    that's the reason I asked here for information. If everybody shares the sliver of information they have, we might be able to get a (nearly) complete picture :-)

    ------------------------------
    Britta Cyron
    Bochum
    Germany
    ------------------------------

    Original Message


  • 6.  RE: CE mark acceptance outside the European Union

    This message was posted by a user wishing to remain anonymous
    Posted 23-Mar-2021 10:04
    This message was posted by a user wishing to remain anonymous

    Hi Britta, 
    You can also add Peru, Bolivia and Argentina.
    Original Message


  • 7.  RE: CE mark acceptance outside the European Union

    Posted 24-Mar-2021 02:35
    Hello everyone,
    1) Do the countries in this list also need the same Technical Documentation as that applicable for Europe?
    2) Would that be the MDD Technical Documentation or the MDR Technical Documentation?

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    Asha Jacob
    Eindhoven
    Netherlands
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    Original Message


  • 8.  RE: CE mark acceptance outside the European Union

    Posted 12-Apr-2021 16:15
    Armenia, Azerbaijan, Georgia and Mongolia - no. They will need much less information.
    Ukraine - yes. So far MDD is fine, but they will transfer to MDR as soon as it will happen in Europe. They are aligned.

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


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