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  • 1.  Rule of the revised DoC with the EU Rep

    This message was posted by a user wishing to remain anonymous
    Posted 27-Mar-2024 16:59
    This message was posted by a user wishing to remain anonymous

    Hello everyone,

    I have a question, whether the revised DoC needs to be verified by the EU representative or whether the company's PRRC can manage this and for minor changes (non-significant) by the manufacturer, verification by the EU representative is not required every time.

    This product is a Class 1 general product and does not require the involvement with the notify body.

    Does anyone know if such updates require notification to the EU representative before we can populate the updated DoC and share it with EU customers?

    Thank you!



  • 2.  RE: Rule of the revised DoC with the EU Rep

    Posted 30 days ago

    Article 11(3)(b) requires the manufacturer to mandate the EC REP to keep available a copy of the declaration of conformity. This implies that they must have the most recent version and therefore, they should receive any updated version. The EC REP should check those changes, just to see if the appropriate conformity assessment procedure has (still) been followed. Therefore, you must share the updated version with your EC REP. From that moment you can start placing the device on the market, but the EC REP may have comments or even willing to terminate their mandate. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 3.  RE: Rule of the revised DoC with the EU Rep

    Posted 30 days ago

    Supporting Ronald's post further: Article 11(3)(a) specifically states that the EC Auth Rep needs to "verify" the EU DoC and File. 

    "(a) verify that the EU declaration of conformity and technical docu­mentation have been drawn up and, where applicable, that an appro­ priate conformity assessment procedure has been carried out by the manufacturer;"

    Best Regards, 

    Stephanie



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    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


  • 4.  RE: Rule of the revised DoC with the EU Rep

    Posted 26 days ago

    Hello Anon,

    To provide further comment, typically we put in place a "management of Technical Documentation" which was a procedure or work instruction.  So not only does the Manufacturer need to ensure the EU Authorised Representative (EU AR) has access to the Technical Documentation, but this must be verified as indicated.  When updates were made to the Technical Documentation index/master file (not updates to documents which may be referenced from the master file) and for sure the Declaration of Conformity there was a "check and balance" between the Manufacturer and the EU AR.  As one example, we had a communication form, single page, which described any changes to the Technical Documentation - of which the Declaration of Conformity is included - which was transmitted by the Manufacturer quality/regulatory (usually the Personal Responsible for Regulatory Compliance [PRRC]) to the EU AR PRRC.  The document was then counter-signed and sent back acknowledging changes to Technical Documentation, thus completing the verification.  The EU AR has "access" to the Technical Documentation, but this communication notice helps to keep the obligations of the Manufacturer and the EU AR all intact.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


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