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  • 1.  MD symbol for marketing purposes

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2023 14:56
    This message was posted by a user wishing to remain anonymous

    What are the ramifications of marketing driving the MD symbol on a device that does not meet any of the classification rules?



  • 2.  RE: MD symbol for marketing purposes

    Posted 21-Dec-2023 01:38

    I can only answer this questions for the European Single market:

    If you place the MD marking on a product that is not a medical device, you may be considered breaching Article 7 of the MDR (about making unjustified or misleading claims related to devices). Most Member States have serious punative measures in place for anybody found guilty of that. I suggest to leave that marking off and go for a different marketing strategy. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 3.  RE: MD symbol for marketing purposes

    Posted 21-Dec-2023 02:55

    The MD symbol is not intended for marketing purposes but for regulatory qualification purposes. If the company deliberately (and knowingly judging by the way your questions is phrased) misrepresents the qualification of the product as a medical devices then this is a good way to get in trouble with authorities (in some countries this would be go to jail and/or hefty fine level of trouble) and the company had better plan for that by for example making this not an obvious strategy by documenting it. And let's hope there is no safety issue with the product as that would massively compliate matters legally and make them worse.

    Also, it's deeply unethical I think to have a business model based on deliberate misrepresentation, especially if the product is not as safe as a medical device should be.

    The ramifications can also include paying a lot of money to third parties to fix this - as a lawyer that has represented companies running with scissors in all kinds of ways I can only say that your lawyer will thank you for your business and buy a nice nice Porsche from the fees. Usually I tell these kinds of clients that if you want to break the law as a business model, there so many ways to do this in a more sophisticated and sustainable way.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 4.  RE: MD symbol for marketing purposes

    Posted 21-Dec-2023 06:44

    Applying a symbol or any other labeling that is not compliant to the meaning of that symbol/ labeling is miss branding in the US. It is false advertising by any definition and there are potential monetary penalties, not to mention you open yourself up to recall, CAPA, etc.



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    Sarah Parsons RAC
    Director Regulatory Affairs, Diagnostics
    Northcoast Consulting
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    Original Message


  • 5.  RE: MD symbol for marketing purposes

    This message was posted by a user wishing to remain anonymous
    Posted 21-Dec-2023 09:13
    This message was posted by a user wishing to remain anonymous

    If the intent was to deceive customers, it might not even work for long. Brokers and retailers would be asking for a declaration of conformity.


    Original Message


  • 6.  RE: MD symbol for marketing purposes

    Posted 22-Dec-2023 05:31

    As mostly clarified by earlier responses, the use of MD symbol on products cannot be merely a marketing drive...and I do not have to restate everything that were previously said by others. Meanwhile, it is important to clarify that Quality and Regulatory team must take the lead on ALL labelling and artwork matters, marketing/commercial claims are not generally aligned with regulatory compliance, so someone must always rein in any non-compliant claims before it creates a bigger problem for the manufacturer. For example, in the UK, it's only a matter of time before the MHRA come calling regarding any unsupported claim found on the product.



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    Abi Bamigbade
    Head of Quality and Regulatory Affairs
    Kays Medical Ltd, UK.
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    Original Message


  • 7.  RE: MD symbol for marketing purposes

    This message was posted by a user wishing to remain anonymous
    Posted 22-Dec-2023 10:35
    This message was posted by a user wishing to remain anonymous

    Thank you all for confirming my thoughts on the topic.


    Original Message


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