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  • 1.  DoCs and CE certificates for products no longer manufactured

    This message was posted by a user wishing to remain anonymous
    Posted 01-May-2018 09:04
    This message was posted by a user wishing to remain anonymous

    Dear All,
    If we are no longer manufacturing a product, will not manufacture it again and wish to obsolete the product from our QMS/Technical documentation (excluding PMS provisions) - at what point should we:
    a. update our DoC
    b. request our NB to remove the code from our CE cert?
    c. which should we update first, CE cert or DoC?
    Many thanks


  • 2.  RE: DoCs and CE certificates for products no longer manufactured

    This message was posted by a user wishing to remain anonymous
    Posted 02-May-2018 12:46
    This message was posted by a user wishing to remain anonymous

    We are currently going through this same process with a CE marked device. We contacted our Notified Body to inform them that we wish to remove the CE mark from a device. They required us to submit a Notice of Change to remove the CE mark. They are working to update the CE cert (to remove this device) and asked that we (the Manufacture) provide them with the serial number of the last unit which will ship with the CE mark included. We then had to update our DoC as a draft with this serial number included and provide it to them before they could move forward with updating the CE cert. The CE cert update will need to be approved and re-issued by the Notified Body. 

    I would recommend you contact your Notified Body and inform them the product you would like to remove, submit a NoC, and they should inform you on the next steps to take. 

    Good Luck!
    Original Message


  • 3.  RE: DoCs and CE certificates for products no longer manufactured

    Posted 02-May-2018 20:22
    ​I will approach the NB first and ensure that the CE certificate is updated based on the proposed change. This will include update of the QMS. I will then update the technical file which include DoC update to reflect the change.

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    Romit Singh
    Senior Regulatory Affairs Specialist
    Belrose
    Australia
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    Original Message


  • 4.  RE: DoCs and CE certificates for products no longer manufactured

    Posted 03-May-2018 02:41
    What has been said is correct . However, the answer depends somewhat by the class of the product. For a class III product a change to the CE certificate is for sure required. For class IIa/IIb, the certificate may be affected or not, depending if removing the product will reduce or not the scope of your cert. Contacting the NB is anyway a good idea.

    Remember that the technical documentation etc need to be kept for 5 year (15 years for implants) after the last product has been manufactured (MDD Annex II, secion 6, other annexes have similar provisions).

    Also, your PMS obligation will remain valid till you have products on the market. For single-use products, you can asume that after the last product has expired you can stop your PMS activities. For other products, implants and capital equipment, it can last a lot longer, depending on the expected lifetime of your device.

    ------------------------------
    Andrea Sparti
    Regulatory Affairs Manager
    Bienne
    Switzerland
    ------------------------------

    Original Message


  • 5.  RE: DoCs and CE certificates for products no longer manufactured

    This message was posted by a user wishing to remain anonymous
    Posted 03-May-2018 08:53
    This message was posted by a user wishing to remain anonymous

    ​I have a few related questions, in reference to catalog numbers for a commercial device.
    • Is it acceptable for the CE certificate/DoC to list catalog numbers that are obsolete (i.e. no longer being manufactured)?
    • Is it acceptable for the CE certificate/DoC to list catalog numbers that were never commercialized (i.e. part numbers and labeling do not exist in the quality system)?
    • When should catalog numbers for a commercial device be removed from a CE cert/DoC?
    • Assuming a revised CE cert (with catalog numbers removed) needs to issued prior to removing catalog numbers from the DoC?
    Any information would be greatly appreciated!
    Original Message


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