Regulatory Open Forum

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  • 1.  CE Mark

    This message was posted by a user wishing to remain anonymous
    Posted 21-Mar-2019 14:53
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    If your EC certificate hasn't expired and you have not tested medical devices for the latest IEC 60601-1 3.1 edition and EMC 4th edition, can you still affix CE mark to your products?

    Thanks


  • 2.  RE: CE Mark

    Posted 22-Mar-2019 03:45
    Hi

    This is a case with all the applied standards of your product. Every time a standard is revised, you have to perform a gap analysis and comply with the new standard. If your gap analysis indicates that you do not have to perform new studies, you have to justify your selection.
    In any case, your CE mark is still valid, but the Notified Body will check your compliance.

    Hope that helps

    ------------------------------
    Spyros Drivelos
    Medical Devices Manager
    Agia Paraskevi, Athens
    Greece
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  • 3.  RE: CE Mark

    Posted 22-Mar-2019 11:01
    ​The deadlines for the 3rd edition of 60601-1 and the 4th edition of 60601-1-2 have passed and they are a requirement to continue to CE mark you device.  Unless you can show proof of compliance, the CE mark must be removed.

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    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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  • 4.  RE: CE Mark

    This message was posted by a user wishing to remain anonymous
    Posted 22-Mar-2019 14:55
    This message was posted by a user wishing to remain anonymous

    Thanks you Spyros & Al Van!
    How does this affect our already registered devices in Australia?
    I know ARTG listing does not expire if you keep paying the annual fee.



  • 5.  RE: CE Mark

    Posted 22-Mar-2019 17:11
    ​The TGA accepts the DofC you provided to your sponsor.  This is usually based on your EU DofC.  If the MDD DofC goes away, the Australian DofC is no longer valid.  Your agreement with your sponsor would require you to notify them.  It is up to your sponsor whether they will continue to market your products in Australia.  They are responsible to the TGA.

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