Regulatory Open Forum

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  • 1.  CE mark database?

    Posted 24-Feb-2017 16:49
    Hello,

    Just curious if any are aware of a CE mark database on par with FDA searchable 510k database?  I have found BSI searchable client list, but not sure if there is a conclusive list somewhere of all CE marked devices in EU?

    Thank you,
    Gretchen

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    Gretchen Upton RAC
    San Antonio TX
    United States
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  • 2.  RE: CE mark database?

    Posted 24-Feb-2017 21:16

    No, there is no database of CE Marked devices.



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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


  • 3.  RE: CE mark database?

    Posted 28-Feb-2017 11:00
    As Julie O. stated, currently there is no public database of CE marked devices.  However, the new European Medical Device Regulation will establish a database system that will allow the public to search CE marked devices.  The regulation is expected to go into effect in Q2 2020.

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    Julie Broderick RAC
    Principal/Consultant
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States
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    Original Message


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