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  • 1.  Falsely Self-Certified IVDD

    This message was posted by a user wishing to remain anonymous
    Posted 26-Oct-2021 10:28
    This message was posted by a user wishing to remain anonymous

    Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?

  • 2.  RE: Falsely Self-Certified IVDD

    Posted 27-Oct-2021 05:25
    Dear Colleague,

    I think all involved parties, that are aware of such a legal noncomplinace/fraud  are responsible both legally and morally.


    Peter Mikó M.D
    ArtPharm Ltd.

  • 3.  RE: Falsely Self-Certified IVDD

    Posted 27-Oct-2021 07:19
    Hmmm good luck.  I would not want to work at a company who, as you said falsely, sells product - disaster wanting to happen.  The answer is: depends on which country would take the legal action according to their local laws and any protection individuals may have under corporate structure.  As example, in the United States thanks to a few companies in the past, the FDA can now prosecute individuals in a company with fines and incarceration.  Also recently with the PIP incident in France, this was also done as well.  And completely agree with Peter definitely a moral issue if the company is knowingly and continues to sell product without maintaining compliance.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Falsely Self-Certified IVDD

    Posted 06-Dec-2021 09:46
    Edited by RACHEL RYLL 06-Dec-2021 09:48
    Couldn't agree more.  I've come accross this In this case of products that are manufactured in the UK and sold accross the UK and the EU, so no FDA involvement.

    Rachel Ryll
    Quality Systems Director


  • 5.  RE: Falsely Self-Certified IVDD

    Posted 27-Oct-2021 11:22
    Did they know it was false? If not, then you may be able to educate them, put together a quality plan and sort it all out (perhaps not without a recall though).

    If so, then honestly, just get out. Most of the time authorities go for top management, but it isn't completely unheard of for the top RA/QA person to also get entangled in it. Particularly with the countries that require appointment of a "responsible person" there is just too much risk, IMO, to stay at such a company.

    If it is not a question of "stay" but being hired to fix things, I'd make sure my contract was written so that I had complete authority over those types of decisions (as well as recalls, safety issues etc)


    Ginger Glaser RAC
    Chief Technology Officer

  • 6.  RE: Falsely Self-Certified IVDD

    Posted 28-Oct-2021 04:16
    simply, run away from such a company

    Evangelos Tavandzis
    Lead Auditor, Consultant
    Czech Republic