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  • 1.  Change of European Authorised Representative

    This message was posted by a user wishing to remain anonymous
    Posted 04-Nov-2019 09:14
    This message was posted by a user wishing to remain anonymous

    ​​Dear All,

    We are planning to change our European Authorised Representative.  It may take time for regulatory procedure to change EAR in some countries.  We, therefore, would like to know the answers to the following questions to prepare a change schedule.

    1) Is it possible to start the regulatory procedure for change before the EAR is actually changed?
    2) I've heard that the change procedure takes longer time for the following countries.  Is it true?  If it is true, do you have any idea how long it may take?
            Belarus, Kazakhstan, Panama, Peru, Costa Rica, Russia
    3) Does the responsibility to the product with the name of old EAR remain on the old EAR even after the change of EAR?

    Your kind help will be highly appreciated.

    Best regards,


  • 2.  RE: Change of European Authorised Representative

    Posted 04-Nov-2019 11:37
    Hi,

    Article 12 of the EU-MDR will answer some of your questions. 

    Change of authorised representative

    The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:

    (a)

    the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;

    (b)

    the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

    (c)

    the transfer of documents, including confidentiality aspects and property rights;

    (d)

    the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.

    I have not worked on the registrations of Belarus, Kazakhstan, Panama, Peru, Costa Rica, Russia, however, I am curious to know how regulatory approvals are affected in these countries if one decides to change the EU Authorized Rep.
     
    Thanks,
    Meenakshi

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Change of European Authorised Representative

    Posted 05-Nov-2019 03:38
    I guess have to ask a fundamental question, why would changing the European Authorised Representative have anything to do with Panama, Peru, Costa Rica, et. al.?  If you are talking about the in country representation for each of those countries there are some requirements for them and some are easier than others.  However a European Authorised Representative only applies if you do not have a physical location in Europe, it has no relevance on the other countries.

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

    Original Message


  • 4.  RE: Change of European Authorised Representative

    This message was posted by a user wishing to remain anonymous
    Posted 06-Nov-2019 09:27
    This message was posted by a user wishing to remain anonymous

    ​Dear Meenakshi,

    Thank you for the information about the change of the authorised representative.  Is there any relevant part of the rep change in IVDD?

    Best regards,
    Original Message


  • 5.  RE: Change of European Authorised Representative

    Posted 06-Nov-2019 11:23
    Dear Anonymous,

    Article 12 of the EU-IVDR corresponds to 'change of authorized representative'

    Best regards,
    Meenakshi

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


  • 6.  RE: Change of European Authorised Representative

    This message was posted by a user wishing to remain anonymous
    Posted 07-Nov-2019 09:17
    This message was posted by a user wishing to remain anonymous

    Dear Meenakshi,

    Thank  you for ​determining the relavant part in EU-IVDR.  I found there was no article describing the change of authorised representative in IVDD.

    Kind regards,
    Original Message


  • 7.  RE: Change of European Authorised Representative

    This message was posted by a user wishing to remain anonymous
    Posted 07-Nov-2019 09:17
    This message was posted by a user wishing to remain anonymous

    Dear Richard,

    Thank you for your comment.  The label and IFU are registered and the name of EAR appears on them.  I hear the authorities of these countries are strict about what is written on the label and IFU.  If not, It's OK and I'm releaved.

    Best regards,
    Original Message


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