Regulatory Open Forum

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  • 1.  EU Study on Regulatory Governance and Innovation in the field of Medical Devices

    Posted 29-Aug-2023 08:28

    Interesting read on the possible future of the EU medical devices regulations - https://medtech.pharmaintelligence.informa.com/MT148209/Should-The-EU-Establish-A-Central-Accountable-Managing-Structure-For-Medical-Devices

    As mentioned, Ernest & Young is performing a "Study on Regulatory Governance and Innovation in the field of Medical Devices" on behalf of the European Commission. I am a member of the Advisory Group for this study, and it has been proceeding smoothly, although with a lot of discussions on many levels.



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    Marcelo Antunes
    Regulatory Strategy Consultant, HAS (Harmonised Standards) Consultant for the European Commission
    Jundiai
    Brazil
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  • 2.  RE: EU Study on Regulatory Governance and Innovation in the field of Medical Devices

    Posted 30-Aug-2023 02:54

    Good to hear that you find the German white paper interesting, I really enjoyed writing it and did my best to come up with good ideas - I'm looking forward to discuss in person if you like at the EY Advisory Group meeting in a few weeks. 



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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  • 3.  RE: EU Study on Regulatory Governance and Innovation in the field of Medical Devices

    Posted 30-Aug-2023 10:24

    Hi Erik, I will join online only this time, maybe in the next meeting I will go in person.



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    Marcelo Antunes
    Regulatory Strategy Consultant, HAS (Harmonised Standards) Consultant for the European Commission
    Jundiai
    Brazil
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  • 4.  RE: EU Study on Regulatory Governance and Innovation in the field of Medical Devices

    Posted 30-Aug-2023 07:16

    Ola Marcelo 

    O link nao funcionou para mim...

    Abs, 



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    Marcos Camargo
    Campinas
    Brazil
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  • 5.  RE: EU Study on Regulatory Governance and Innovation in the field of Medical Devices

    Posted 30-Aug-2023 10:25

    Olá Marcos, o link está funcionando para mim. Tente buscar no Google por "Should The EU Establish A Central Accountable Managing Structure For Medical Devices?" que ele vai te levar diretamente ao artigo. 



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    Marcelo Antunes
    Regulatory Strategy Consultant, HAS (Harmonised Standards) Consultant for the European Commission
    Jundiai
    Brazil
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