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  • 1.  Declaration of Conformity

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2017 11:21
    This message was posted by a user wishing to remain anonymous

    Hello ,

    I am looking for two information regarding the Declaration of Conformity.

    - Who should sign the DoC? Is there a requirement and if yes, where can I find it? To my experience the DoC has always been signed by the Managing Director, but is there any specific regulatory requirement defining this point?

    - A firm decides to discontinue distributing some medical devices (implants or instruments), not due to safety reasons, but in order to optimize the product portfolio. The devices will remain on the market, until they will be used according to their "used by" date, they will not be recalled or removed, but they will not be manufactured and sold anymore.

    Must these devices (part numbers) still be listed on the Declaration of Conformity, when the document will be updated? If yes, which is the related regulatory requirement, which applies?

    I will appreciate any feedback regarding these two points.

    Thank you!

    Kind regards,


  • 2.  RE: Declaration of Conformity

    Posted 18-Sep-2017 11:04
    1. For the contents of the DofC, I would look into Article 19 and Annex IV of the MDR.  It does not specify who has to sign the DofC, just that someone from the company needs to make that declaration.
    2. If the discontinued devices have already been sold and there will be no more produced, there is no need to call them out on a DofC.  If you have items in stock which will be sold to depletion, you will need a valid DofC at the time they are sold.


    ------------------------------
    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Spacelabs Healthcare, Inc
    Snoqualmie WA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Declaration of Conformity

    Posted 18-Sep-2017 12:09
    I agree with Al, and would add that your reference the following (which have been quoted by various competent authorities, see for example ZLG Conformity Assessment document 3.9 A4, Declaration of Conformity)

    • EN ISO/IEC 17050-1 : 2004 Conformity assessment – Supplier's declaration of conformity – Part 1: General requirements 
    • EN ISO/IEC 17050-2 : 2004 Conformity assessment – Supplier's declaration of conformity – Part 2: Supporting documentation 





    Original Message


  • 4.  RE: Declaration of Conformity

    Posted 18-Sep-2017 17:16
    ​The GHTF Guidance Document GHTF/SG1/N78:2012 states the Declaration of Conformity should include "The name, position, and signature of the responsible person who has been authorised to complete the Declaration of Conformity upon the manufacturer's behalf."

     

    Regards



    ------------------------------
    Homi Dalal RAC
    Regulatory Affairs Leader
    Dynamic Controls
    Christchurch
    New Zealand
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    Original Message


  • 5.  RE: Declaration of Conformity

    Posted 25-Sep-2017 16:48
    Dear All,

    thank you very much for your replies. They were all very helpful.

    I would like to ask Al about any reference to the second point (discontinue of distributing some medical devices), if there is any regulatory reference which can support this evaluation, which I also share.

    Any information is very much appreciated.

    Thank you!

    Kind regards,
    Vasiliki

    ------------------------------
    Vasiliki Begkou RAC
    Senior, Regulatory Affairs Manager
    Germany
    Germany
    ------------------------------

    Original Message


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