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  • 1.  UKCA marking

    Posted 12-Aug-2022 07:18
    Dear all,

    not to re-open old wounds, but I would like to know if the transition period for UKCA is official yet, or still part of the consultation document from UK government. Can I consider the intention for a transition period a nearly sure thing or do I need to wait for the official communication?

    Thank you


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    Christian Micheletti
    Project Manager; Regulatory Affairs expert
    Goldach
    Switzerland
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  • 2.  RE: UKCA marking

    Posted 13-Aug-2022 09:12
    Dear Christian,

    There are two transition periods to consider now in Great Britain.

    First, the Brexit transition, which requires UKCA marking for medical devices by next June.
    https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

    Then the transition from the Brexit version of the UK MDR 2002 to the new and not yet formalized UK Medical Devices Regulations, which anticipates three years after publication for medical devices and five for in-vitro diagnostics.
    https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/outcome/chapter-15-transitional-arrangements

    Of course things can always change, but considering the expressed reasons for a transition period, I'd call it a nearly sure thing.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: UKCA marking

    Posted 14-Aug-2022 05:33
    Hi Christian,
    Overall for UKCA yes we're in transition with CE ending recognition as the conformity standard in the UK for new Medical Devices in July 2023. (As written)

    However the consultation has ended and the UK Governments response was published in June.

    This indicated potential transition timescales for existing CE products and if made official might allow longer grace periods for say EU MDR products placed on the UK market.

    We're now awaiting the new UK MDR to be officially approved and published for definitives.

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    Max Trebilcock
    UK Responsible Person | RAQ Specialist
    Vega Healthcare Solutions
    London
    United Kingdom
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    Original Message


  • 4.  RE: UKCA marking

    Posted 15-Aug-2022 02:51
    Hello Christian,

    I mirror what the others have said, I believe also there will be some transition period.  MHRA are already quite aware there are only three (3) designated UK Conformity Assessment entities and there is still a mountain of work, review, an resources needed to get existing products (not even considering new products) UKCA mark.  It has been published that June 2023 will be the end date for CE Marking, but I personally do not think that will be "the end."  I expect there will be longer extension period of CE Mark products, though I fully believe this will only be EU MDR certified products and not EU MDD since the new UK regulation is similar to the EU MDR.

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


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