Regulatory Open Forum

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  • 1.  EU MDR and classification of products without an intended medical purpose: When?

    Posted 24-Sep-2021 09:49
    Hello RegEx friends,

    Anyone have any information on when this document is planned to be published? Any whispers about a status?

    From https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en

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    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
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  • 2.  RE: EU MDR and classification of products without an intended medical purpose: When?

    Posted 25-Sep-2021 04:21
      |   view attached
    Hey Correy
    according to the attached updated implementation plan from the European Commission (see page 2 first row)- it is expected on Q1 2022. 
    The problem is that their plans change a lot....
    Best
    Ella

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    Ella Sheiman
    Haifa
    Israel
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  • 3.  RE: EU MDR and classification of products without an intended medical purpose: When?

    Posted 27-Sep-2021 09:21
    Perfect, Ella, thank you!

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    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
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