Regulatory Open Forum

 View Only

  • 1.  MDR Article 22 Statement of Compatibility

    This message was posted by a user wishing to remain anonymous
    Posted 03-Apr-2023 08:02
    This message was posted by a user wishing to remain anonymous

    Should a MDR Article 22 Statement of Compatibility be included with a Declaration of Conformity or should it be a stand-alone document?  Does anyone have an example of a such a statement?  Thank you.



  • 2.  RE: MDR Article 22 Statement of Compatibility

    Posted 03-Apr-2023 09:41

    Hi Anon,
    the MDR Articel 22 statement should be a separate document. I do not have a current example, but maybe someone else does.

    Best regards
    Christoph



    ------------------------------
    Christoph Kiesselbach
    Reutlingen
    Germany
    ------------------------------

    Original Message


  • 3.  RE: MDR Article 22 Statement of Compatibility

    Posted 03-Apr-2023 12:44

    Because an EU MDR Article 22 system or procedure pack Statement of Compatibility (SoC) has a different legislative purpose than the Article 19 Declarations of Conformity (DoC) for the components inside the system or procedure pack, then the SoC and DoC need to be prepared separately in order to avoid legislative mishaps.  For an example of an Article 22 SoC, my opinion is that Article 22(2) already contains a sufficient boilerplate.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


Related Content