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Declaration of Conformity 93/42/EEC

Discussion in 'EU Medical Device Regulations' started by Michelle Dempsey, Apr 13, 2016.

  1. Michelle Dempsey

    Michelle Dempsey New Member

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    Hi,
    I am new to this forum. I was wondering did anyone know how long a class 1 medical device product has to stay on the DOC when it has been discontinued. We state the lifetime of our product is 7 years, so does it have to stay on the DOC for 7 years?
     
    Michelle Dempsey, Apr 13, 2016
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  2. Vintage Goose

    Vintage Goose Active Member

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    If the device is discontinued and is no longer being placed on the market, then there is no requirement to have a DoC.

    However, per ISO 13485, you do need to retain documentation for the lifetime of the product.

    Chris
     
    Vintage Goose, Apr 13, 2016
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  3. Michelle Dempsey

    Michelle Dempsey New Member

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    Thank you, much appreciated.
    Michelle
     
    Michelle Dempsey, Apr 13, 2016
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  4. Pads38

    Pads38 Member

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    See also MDD Annex II, clause 6.

    DoC and other paperwork is required to be retained for 5 years (15 if implantable) after last production.
     
    Pads38, Apr 13, 2016
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