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  • 1.  CE Mark expiration

    Posted 25-Apr-2017 12:37
    Good afternoon,

    Our company exports devices to Jamaica and the CE marking on one of these devices is expiring in 2 weeks. Company wants to export this device to Jamaica in July. Is it possible? What are the regulatory hurdles? Any leads into this matter would be greatly appreciated.
    Thanks in advance.

    Sudha


  • 2.  RE: CE Mark expiration

    Posted 25-Apr-2017 20:19

    I think the main hurdle will be getting an NB to renew the CE certification. 

    If you can work with the same NB that issued the expiring certificate, renewal will almost certainly go faster than if you go with a new NB.  A new NB may want to re-review some or all of the documentation that the original NB reviewed, and may not come to all of the same conclusions as the original NB.  If you are lucky, the original NB will review only new information since the original certification, because they already accepted everything that was submitted for the original certification.

    Either way, good luck with that.  It seems that the NBs that are still standing are pretty much slammed these days.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: CE Mark expiration

    Posted 26-Apr-2017 21:44
    Julie,

    Thank you for your input! We will contact the original NB and try our luck:)

    Sudha


    Original Message


  • 4.  RE: CE Mark expiration

    Posted 25-Apr-2017 23:31
    Also, no promises, but if you have a supply of these devices on hand, or can manufacture a supply of them before the CE certification expires, you may be able to export these, since they were CE certified at the time they were manufactured.  This is a possibility you could discuss with the certifying NB, and the sooner, the better, I would think....

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 5.  RE: CE Mark expiration

    Posted 27-Apr-2017 00:16
    Thanks Julie for your insights.

    Hi Sudha - Besides Julie's input, another perspective is - does Jamaica requires CE marking to sell your products?
    If products are already registered in Jamaica, until the license is valid you are ok to sell the products.

    To renew your CE Certificate: while it is under review with your NB, you can request a letter from your NB to issue the status and grant permission for continuation of sales, provided if no changes to the product. But again, this depends on product classification and your NB assessment.

    Hope this helps!

    Regards
    Sreenu

    ------------------------------
    SATTU Sreenu
    Regulatory Affairs Manager
    Singapore
    ------------------------------

    Original Message


  • 6.  RE: CE Mark expiration

    Posted 01-May-2017 17:36
    Sreenu, and thanks also for yours.  I'm aware only that there are circumstances in which CE marked devices can be sold after the certification expires, but was not aware of this option.  Good to know!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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