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EU FSC on systems/procedure packs under MDD Article 12

  • 1.  EU FSC on systems/procedure packs under MDD Article 12

    This message was posted by a user wishing to remain anonymous
    Posted 04-Aug-2017 11:55
    This message was posted by a user wishing to remain anonymous

    ​​

    Dear all,

     

    I would like your help on FSC on systems/procedure packs under MDD Article 12, 'Particular procedure for systems and procedure packs and procedure for sterilization'. 

     

    Following this procedure, a company combines medical devices that each maintains and bears its own CE marking; however, the assembled system itself does not bear a CE marking.

     

    In this case, a single FSC (Free Sales Certificate) to cover the assembled system is not issued by the Competent Authority?

     

    I am looking forward to your advice.

     

    Thanks and best regards,



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