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  • 1.  System/Procedure pack

    Posted 06-Mar-2024 11:16

    Hi All,

    It is required by EU MDR article 22 that a statement should be drawn for the system/procedure pack. Should this statement be included in or separated from the Declaration of Conformity? 



  • 2.  RE: System/Procedure pack

    Posted 06-Mar-2024 12:47

    Hi Ning,

    the article 22 statement is a separate document. The system/procedure pack does not have a Declaration of Conformity in itself (except in the Article 22(4) case), because it is not considered a device. Each component of the system/procedure pack that is a device then has its own Declaration of conformity.

    Best regards, Christoph

    Christoph Kiesselbach
    Schrack & Partner

  • 3.  RE: System/Procedure pack

    Posted 07-Mar-2024 04:02
    Edited by Ning Wang 07-Mar-2024 04:02

    Christoph, Thank you! 

    Ning Wang