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  • 1.  UKCA Marking Deadline

    Posted 23-Apr-2023 14:50

    Could any one confirm me the deadline for UKCA marking. 

    As per my research, it was 1st July 2023. However, it is currently extended to 1st July 2024. 


    Could anyone confirm the date by providing reference from official website Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk)



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    Arslan Rahat
    QA Manager
    Toronto ON
    Canada
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  • 2.  RE: UKCA Marking Deadline

    Posted 24-Apr-2023 07:18
    Edited by Olga Peycheva 24-Apr-2023 07:18

    Hello Arslan,

    You can refer to MHRA guidance below.

    https://www.gov.uk/guidance/using-the-ukca-marking#when-the-ukca-marking-comes-into-use

    Have a great week,
    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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    Original Message


  • 3.  RE: UKCA Marking Deadline

    Posted 24-Apr-2023 07:22

    Hello Arslan.

    Here is a link to the MHRA web page indicating that the deadline for UKCA marking has been extended by 12 months until 30 June 2024.
    https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period

    While writing, you may be interested to know that MHRA also plans to extend this deadline further for CE marked devices in accordance with the UK Government's response to the September 2021 public consultation on the future of medical device regulation in the UK. In the response document, pages 153-4, MDD CE marked general medical devices will have until at least 2027 to apply the UKCA mark, while MDR CE marked general medical devices will have until at least 2029. A UK regulation implementing these extended UKCA marking timelines is expected within Q2 2023.

    I hope this helps.



    ------------------------------
    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience
    Clinical Studies - Regulatory - Quality Systems
    AR/UKRP services
    Italy and UK
    rgray@donawa.com
    www.donawa.com
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    Original Message


  • 4.  RE: UKCA Marking Deadline

    Posted 24-Apr-2023 09:19

    Hi Arslan

    The dates you mention are correct, but we are still waiting to see the formal amendment of the legislation to move the deadline back from 2023 to 2024. Then we are expecting new legislation later this year which will outline the future regulatory framework and the transition timelines for CE marked devices (for use in GB, as NI will continue to accept CE marked devices).

    Regards
    Ed



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    Ed Ball
    Manager, Intelligence & Innovation
    United Kingdom
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    Original Message


  • 5.  RE: UKCA Marking Deadline

    Posted 25-Apr-2023 12:41

    To clarify for all, there needs to be a change of the legislation to move the June 2023 deadline back to June 2024. All we have at the moment are public announcements from the MHRA about this move, but the legislation has still not changed. We were expecting the new Statutory Instrument to be out by now.



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    Ed Ball
    Manager, Intelligence & Innovation
    United Kingdom
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    Original Message


  • 6.  RE: UKCA Marking Deadline

    Posted 24-Apr-2023 09:53
    Hi Arslan, deadline for application is July 1st 2024 



    Original Message


  • 7.  RE: UKCA Marking Deadline

    Posted 25-Apr-2023 02:33

    Based on an exchange with someone working for MHRA, I expect they will allow for valid CE-certification for some time. The problem in the UK is that they have limited capacity in UK Approved Bodies. This capacity issue will remain for some time. Unless the UK wants to ban safe and effective devices off their market and claim that as a Brexit benefit, they have to accept devices from other markets.
    They are also looking into the option Switzerland is exploring regarding devices that are allowed on other markets, like the US. However, there is a price to pay if you want to do that. So it may take some time before that option is available, if ever.
    If you want to place devices on the Great Britain market, I recommend for now to go for CE-marking. This will also give you access to the EU market and other global markets that accept CE-marking. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 8.  RE: UKCA Marking Deadline

    This message was posted by a user wishing to remain anonymous
    Posted 26-Apr-2023 08:09
    This message was posted by a user wishing to remain anonymous

    Hi all,

    I'm piggybacking on Arslan's post with a related question. Currently, the UKCA marking deadline is slated to be pushed back to June 2024. If a manufacturer has already obtained UKCA certification through a notified body, would this obligate the manufacturer to update their labeling to include the UKCA mark, UK responsible person, etc...or, would that manufacturer only be required to update their labeling by the expected June 2024 deadline?

    Thanks!


    Original Message


  • 9.  RE: UKCA Marking Deadline

    Posted 26-Apr-2023 10:58
    Edited by Sydney O'Connell 26-Apr-2023 11:42
      |   view attached

    To the question about adding the UKCA symbol and UKRP:

    If the device is UKCA marked, then you should have the information appropriately applied to your labeling, including updating your UK registration to note that the device is being marked on the basis of UKCA marking instead of CE Marking. Otherwise, if you plan to let your UKCA marking remain dormant, then you may want to confirm with your UK Approved Body and/or MHRA that it is acceptable to leave the UKCA marking symbol and other relevant information off your labeling and register and sell in Great Britain only referencing your CE marking. The UK's system currently allows for this confusion, so we would recommend confirming with them if UKCA marking supersedes CE marking, once obtained. And therefore, the registration should be updated to show the device is marketed on the basis of UKCA marking instead of CE Marking. Or, if the MHRA considers it the manufacturer's choice. 

    If you have registered your devices with the MHRA based on your CE-marking, and do not yet have UKCA marking, then you do not need to make any updates to the labeling, DoC, etc. And in fact, the UKCA symbol should not be used, since the device is not lawfully UKCA marked. 

    As mentioned above, UKCA marking has been pushed to July 2024, and the MHRA announced a further 3-5 year transition period will be granted for CE Marked devices. The MHRA announced it would also recognize the new extension to the MDR's transition period. 

    The MHRA has stated in a recent webinar, that they intend to release the transition arrangements earlier than the new regulation, sometime this spring. Here's the link to the webinar: https://www.youtube.com/watch?v=Px7SIk7bwzU and attached is the slide with the dates for release of the transitional arrangements, new PMS system and new medical device regulations. 

    So per the MHRA, CE marking is here to stay in the UK, for at least the next 5 years (shorter for MDD/AIMDD legacy devices). Though, we'll know the exact dates once the formal transitional provisions are released. 

    And, since the UK stated they plan to allow products from other well-reputed regulators, such as the US FDA, there will be more avenues for companies to market their devices aside from UKCA marking. 



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


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