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Signing an Article 12 document

Discussion in 'EU Medical Device Regulations' started by Walker, May 9, 2016.

  1. Walker

    Walker New Member

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    Hi,

    I'm new to the CE marking process, so hopefully someone can point me to the right direction. The current issue is, we got a new CE marked product (A) from another company and now trying to merge such product to our which is also CE marked (B). What is it that you need to verify prior to signing such Article 12 document? Correct me if I'm wrong, the purpose of Article 12 is to state that device A is compatible with device B. So testing was done and product A does work with product B. In addition to such tests, do we have to verify that product A has all their Design and V/V docs and procedures in place? Hope that wasn't too confusing. ;)
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi, you don't need to do any testing specifically on Product A, but you may want to do a supplier audit to ensure that their design and V&V are in place, or appropriate goods-in inspection.

    The declaration you sign is verifying that:
    • the product A and B will work together,
    • that suitable packaging is in place,
    • appropriate information or IFUs are provided and
    • that you have appropriate methods of control and inspection in place.
    Having all these documented, you can draw up the declaration.

    Remember both devices are already CE Marked and you are not adding an additional CE Mark.

    Chris
     
  3. Walker

    Walker New Member

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    Thanks for the reply Chris, the Article 12 was signed now we are missing V&V docs. A simple project turned into a nightmare of a headache, thanks again for the advice.
     

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