Regulatory Open Forum

 View Only

  • 1.  Draft Standardization Request

    Posted 31-Oct-2020 14:21

    Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746

    is available at

    https://ec.europa.eu/docsroom/documents/43584?locale=en



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------


  • 2.  RE: Draft Standardization Request

    Posted 31-Oct-2020 22:03
    Dan,

    Thanks for the link to the draft guidance.  It's appreciated.

    ------------------------------
    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
    ------------------------------

    Original Message


  • 3.  RE: Draft Standardization Request

    Posted 01-Nov-2020 12:14
    Thanks for posting this important DRAFT, Dan. At least there is some progress towards Harmonized Standards for MDR and IVDR. This is a hopeful sign, but I'm sure much work needs to be done before we see a list of Harmonized Standards.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


Related Content