Regulatory Open Forum

 View Only

  • 1.  Notified Body

    Posted 23-Jun-2016 09:27

    Does anyone have suggestions for Notified Bodies they have worked with and are accepting new clients?

     

    Finding a Notified Body with the capability to support CE marking of an implanted infusion port (port) in compliance with the Medical Device Directive and is accepting new clients has been more of a challenge than expected. The port is a MDD Class III device.

     

    Specific contact phone number or email with a Notified Body representative is appreciated. Thanks.

     

    ------------------------------
    Gary Syring RAC
    Prin Consultant
    Quality & Regulatory Associates LLC
    Stoughton WI
    United States
    ------------------------------


  • 2.  RE: Notified Body

    Posted 24-Jun-2016 01:36

    Well, at this point, I probably wouldn't go with BSI. :(

    Hopefully something reasonable will be worked out for those devices already holding CE certifications issued by the notified bodies designated by MHRA.

    Even without Brexit, this doesn't seem to be a happy time to be looking for a notified body, especially for a Class III device.  Presumably one reason you are having a hard time finding one is because of the pressures anticipated from the new MDR/IVDR, and especially those applicable to Class III devices, which appear to have led to a declining number of notified bodies already. As I understand it, no one is sure how many notified bodies will qualify for designation under the new regulations, especially for review of Class III design dossiers.

    Now I am also wondering what impact Brexit might have on the new regulations.

    I have not been following the MDR/IVDR saga closely, but under the circumstances I hope others here might be able to provide some wisdom beyond just recommending a "good" notified body...not just for you, but for all of us waking up to a new situation in the EU this morning.

    ------------------------------
    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

    Original Message


  • 3.  RE: Notified Body

    Posted 25-Jun-2016 09:26

    Although I have no inside information and am not a client or an employee of BSI, at this point I would not automatically dismiss BSI as a possibility.  They are an excellent company and perhaps they will find a way to continue to provide the valuable service that they have until now provided.

    ------------------------------
    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States

    Original Message


  • 4.  RE: Notified Body

    Posted 25-Jun-2016 10:48

    For me it mostly adds one more reason to follow advice I've been giving to clients for some time now, which is not to automatically assume that it is easier to get CE marking than FDA clearance.

    ------------------------------
    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

    Original Message


  • 5.  RE: Notified Body

    Posted 24-Jun-2016 14:16

    Hi Gary,

    I've always used TUV USA, Inc. (part of TUV Nord Group in Germany) - they are responsive, cost-effective, gives lots of info, and very nice to work with.  I'm not sure if they cover your product as I've primarily worked with Class IIb in EU.  Either way here's the project manager contact:

    Diana Sweeney

    TUV-USA, Inc.

    Project Manager

    603-870-8023 Ext. 230

    Good luck to you!

    ------------------------------
    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message