Regulatory Open Forum

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  • 1.  Updated UKCA Timeline

    Posted 07-Feb-2023 11:27
    Hello all,

    Can anyone point me to updated timeline and guidance on the UKCA regulatory path now as well as information on the MORE system?

    I am finding minimal helpful information through searching 

    Thanks, all help would be appreciated!

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    Mallory Bartel
    Regulatory Affairs Associate
    Warsaw IN
    United States
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  • 2.  RE: Updated UKCA Timeline

    Posted 07-Feb-2023 12:44
      |   view attached
    Hi ,
    All medical devices, including 
    IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA. In addition, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the Great Britain market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.
    Registration can be made via the Device Online Registration System (DORS). The MHRA may request additional technical information before a product's registration on the DORS is confirmed.
    Manufacturers must report post-market vigilance reports to the MHRA. Reports relating to adverse incidents for devices to the MHRA can now be submitted via the new MORE portal
     The following groups are available for registration process -Manufacturers,
    − Authorized Representatives (NI),
    − UKRP
    − Other importers, distributors, or submitters 



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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    Attachment(s)



  • 3.  RE: Updated UKCA Timeline

    Posted 07-Feb-2023 14:36
    Hello Mallory

    There is information on the MHRA pages.

    UKCA marking:  https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

    Extended timeline:  https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period

    MORE portal:  https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance


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    Anne LeBlanc
    United States
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  • 4.  RE: Updated UKCA Timeline

    Posted 08-Feb-2023 10:27
    Hi Mallory,

    As noted in the link provided by Anne, the UKCA marking deadline was moved from July 2023 to July 2024. Further, in that link the MHRA announces that they will implement a transition plan. This means that the following transition periods apply:

    • MDR, IVDR, and IVDD CE Marked devices – five (5) year transition period after the new regulation takes effect, i.e., through July 2029
    • MDD and AIMDD CE Marked devices – three (3) year transition period after the new regulation takes effect, i.e., through July 2027


    Devices UKCA Marked under the current regulatory framework will have the following transitional period:

    • UKCA Marked medical devices – three (3) year transition period after the new regulation takes effect, i.e., through July 2027
    • UKCA Marked IVDs – five (5) year transition period after the new regulation takes effect, i.e., through July 2029


    The caveats outlined for both CE Marked and UKCA Marked devices are as follows:

    • "devices that are subject to significant changes in design or intended purpose will be excluded from these provisions"
    • "all post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements"

     

    The MHRA announced that they'll introduce new post-market requirements prior to release of the new regulation. The new PMS requirements are expected this year, and the new regulation by July 2024.

    Note that this does not exempt manufacturers from registering their devices with the MHRA, nor does it exempt foreign manufacturers from appointing a UK Responsible Person (UKRP). Whether the device is CE Marked or UKCA Marked, it must be registered before it can be placed onto the UK market. Where applicable, the designated UKRP will complete the registration on the manufacturer's behalf.



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    Sydney O'Connell
    Director of Global Representation
    www.casusconsulting.com
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