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  • 1.  Declaration of Conformity (MDD CLass III)

    Posted 26-Nov-2019 05:19
    Hi all,

    we had an interesting discussion at the office and came to no real conclusion:
    Who should sign the Declaration of Conformity (DoC)?
    At our company and others I have worked for, the quality management representative signs the DoC. With one of our suppliers, the technical manager signs the DoC.
    I found a German guidance document (EK-Med 3.9 A4, text is in English) regarding DoC which states that it shall include the legally binding signature and function of the authorised person. However, it does not define the authorized person.

    Thank you for your thoughts!

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    Britta Cyron
    Bochum
    Germany
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  • 2.  RE: Declaration of Conformity (MDD CLass III)

    Posted 27-Nov-2019 05:22
    The Declaration of Conformity is an official regulatory document​ of the legal manufacturer stating compliance with the applicable European Directives and/or Regulations. The DoC is signed by name and function, it seems logical to me that this person is authorised by the legal manufacturer to do so. Otherwise that DoC is legally not binding. I am not a lawyer, but this seems to me the logical explanation.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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    Original Message


  • 3.  RE: Declaration of Conformity (MDD CLass III)

    Posted 29-Nov-2019 07:29
    The DoC states that a medical device is in conformity with certain regulatory documents. The competency to make such a judgement and the responsibility over the product's safety, reliability, and effectiveness has the QM Representative. Thus, he/she typically signs a DoC. Or the CEO signs because the QMB "was on vacation", which has a certain meaning for external auditors.

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    Richard Jansky
    Wattwil
    Switzerland
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    Original Message


  • 4.  RE: Declaration of Conformity (MDD CLass III)

    Posted 02-Dec-2019 03:21
    Thank you your your insights! This has been helpful.

    Regards,

    Britta

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    Britta Cyron
    Bochum
    Germany
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    Original Message


  • 5.  RE: Declaration of Conformity (MDD CLass III)

    Posted 02-Dec-2019 12:28
    The DoC is signed off by the company's RA or QA representative, preferably from the upper management team. I normally go to the VP of RA/QA to sign these types of documents.

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    Jo Huang RAC
    Sr. Regulatory Affairs Specialist
    Athens TX
    United States
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    Original Message


  • 6.  RE: Declaration of Conformity (MDD CLass III)

    Posted 03-Dec-2019 04:46
    This is correct should be an individual authorised to sign on behalf of the company, so regardless of the position there should be a clear definition of who this individual is signing these regulatory documents, i.e. include in the job description roles and responsibilities to show they are authorised.  In fact, under the EU MDR/IVDR based on Article 15 I would even infer the person responsible for regulatory compliance should be the individual signing all DofCs.  If you read through the test in Article 15, they basically already have this responsibility, so if you include in your quality system the person responsible for regulatory compliance is person 'x', function 'y' then they would be default sign regulatory documents - thus the DofC.  Also keep in mind if your responsible authorised person signing DofC leaves the company, make sure to update all DofCs ... I have seen so many times a DofC two years old with the same signature of the individual that has not worked at the company for over one year.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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