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  • 1.  Self-declaration and CE mark

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jun-2022 09:59
    This message was posted by a user wishing to remain anonymous

    Hi,

    Simple question, but just want to confirm.

    For a Class 1 device (non-sterile) that has a declaration of conformity that is self-declared to the EU MDR, can you place a CE mark (without the 4-digit number) on that device if you have a CE mark for the sterile version?

    Thanks in advance!


  • 2.  RE: Self-declaration and CE mark

    Posted 30-Jun-2022 02:45
    Confusing question. The notified body involvement for a sterile class I device under MDR is limited to sterility only, so that CE certificate does not entitle you to declare conformity for the non-sterile version. If the non-sterile version is itself already subject to a valid declaration of conformity under the MDR, of course you can put the CE mark on it, because that is what the declaration of conformity allows. There is no notified body involvement with the non-sterile version.

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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 3.  RE: Self-declaration and CE mark

    Posted 30-Jun-2022 06:32
    Hello Anon,

    If you have a non-sterile and sterile version of the device, by default it would be reviewed by the Notified Body.  You could theoretically have a separate Declaration of Conformity (DofC) for the non-sterile version and sterile version with different labels, etc.  In simple answer yes it is possible, but you would really need to have different part numbers, different DofC, different labels, etc.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Self-declaration and CE mark

    Posted 30-Jun-2022 07:26
    Hi Anon

    Just make sure before you produce the declaration of conformity for the non-sterile version that your technical documentation covers it adequately. Much of what you have for the sterile version will be applicable, but the labeling will be a little different, the risks will be a little different, you may need to validate instructions for how the users can do their own sterilization, and so on.

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    Anne LeBlanc
    United States
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    Original Message


  • 5.  RE: Self-declaration and CE mark

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jun-2022 08:55
    This message was posted by a user wishing to remain anonymous

    Per the MDR, Class I non-sterile (and/or non-measuring) are self-declared, which do not require notified body conformity assessment review. Class I self-declared medical devices will have a CE Mark without a notified body number due to no notified body involvement. The sterile version however, will have the CE Mark with the notified body number.
    Original Message


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