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  • 1.  UKCA on Patient Implant Card and Patient Information Leaflet

    Posted 28-Mar-2023 15:50

    Hi all,

    I am curious to understand whether or not we require to have UKCA symbol on a Patient Implant Card and/or Patient Information Leaflet for an implantable medical device.

    Thanks!



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    Shikha Malik
    Sr. Regulatory Affairs Specialist
    Frisco TX
    United States
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  • 2.  RE: UKCA on Patient Implant Card and Patient Information Leaflet

    Posted 29-Mar-2023 06:11

    Hello Shikha,

    There is nothing specific on placement of UKCA regarding a patient implant card or information leaflet as the UK medical device regulations has not been updated specific for this information.  Personally, I think it might only be needed on the direct device packaging, but may not necessarily detract.  I might suggest you contact the Approving Body working with and inquire with them if this is needed, expected, or could be done.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: UKCA on Patient Implant Card and Patient Information Leaflet

    This message was posted by a user wishing to remain anonymous
    Posted 29-Mar-2023 06:51
    This message was posted by a user wishing to remain anonymous

    The UK MDR 2002 is currently enforced which is in accordance with EU AIMDD requirements, CE Marked devices can be placed on the Great Britain market until June 30, 2024. The new UK regulations are said to be introduced to legislation in Spring 2023. The new UK regulations are to be implemented and UKCA Mark will be enforced for devices to remain on the Great Britain market in July 2024; a 12-month extension from the regular timeline of July 2023.


    Original Message


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