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  • 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 an Article 22 statement of compatibility be included in the Declaration of Conformity or is it a standalone document?  Does anyone have an example of one?  Thanks in advance.



  • 2.  RE: MDR Article 22 Statement of Compatibility

    Posted 06-Apr-2023 14:02

    In my experience at my previous company, we released a statement as a stand-alone document and included that in the technical documentation.  It is not required to be on the DOC.



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    Liz Bereza, MSRA, RAC-Devices, CMDA
    Senior Regulatory Affairs Specialist
    Raleigh NC United States
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    Original Message


  • 3.  RE: MDR Article 22 Statement of Compatibility

    Posted 07-Apr-2023 02:56

    To add to that, a Declaration of Conformity is not required for systems and procedure packs following Article 22 of the MDR. All the CE-marked devices of the system or in the procedure pack already have a DoC, and the other products of the system or in the procedure pack are in conformity with other EU legislation. 



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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
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    Original Message


  • 4.  RE: MDR Article 22 Statement of Compatibility

    Posted 07-Apr-2023 08:02

    The MDR Declaration of Conformity covers the individual device. The Statement of Compatibility from Article 22 must mention the products in the system or procedure pack (devices or other) and the System and Procedure Pack Producer must declare that the devices in the system or procedure pack are compatible with eachother and that they are used within their intended purpose, in order to achieve a specific medical purpose. The system or procedure pack must be registered in EUDAMED (once that becomes applicable) and a specific UDI must be assigned. In the case of a procedure pack, this must be added to the labeling. 



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    Ronald Boumans
    Netherlands
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    Original Message


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