Is the UKCA system still active?

In today's  US Medical equipment website (meddeviceonline.com/doc/navigating-the-medtech-regulatory-landscape-in-switzerland-and-the-u-k-001) it states that the UK is continuing to push the UKCA system for medical equipment registration, in place of the EU CE certification mark.

.Based on earlier reports I was under the impression that the requirement for UKCA branding had been discontinued.

Peter Brooks

Palm Bay Florida US  

  • nope, no changes, both are acceptable, and will remain so for the foreseeable future - its a sticker exercise, as the same technical standards apply in any case for UKCA and CE, latest advice has removed the sunset date that was 31 dec 2024, so both remain forever. 

    https://www.gov.uk/guidance/using-the-ukca-marking#full-publication-update-history

    • CE recognition end date of 31 December 2024 removed. References to new legislation included which the government has laid to continue recognition of current EU requirements for a range of product regulations, including the CE marking, meaning businesses will have the flexibility to use either the UKCA or CE marking to sell a range of products in Great Britain. Relevant products and affected sectors have been included, as well as general updates to the guidance.

    Mike.

  • Hello Mike:

    If I was a supplier of medical equipment in the US with a CE mark why would I seek additional  UKCA approval, as there is no longer a sunset date?

    Peter Brooks

    Palm Bay 

  • You don't need to any more. You do one lot of tests and fix either both stickers or just one as you see fit. It is also useful for UK manufacturers exporting out (*), for the same reason.

    It was the UK manufactures that asked for the date to be extended forever, and after a lot of grumbling, it has been done.

    Mike.

    ( * not useful for exporting to the US of course but that's a different matter.)

  • Hello Mike:

    A lot of medical equipment is now being developed with AI software, so ignoring the UKCA system completely is also valid for software as well!

    Then I assume it would also apply to "commercial" equipment as well - example hearing aid application developed for Apple based equipment.

    Peter Brooks

    Palm Bay 

  • Hello Mike:

    This then leads us to possible full encryption of medical data when communicated to pre-approved third parties and the latest Apple disagreement with the UK government.

    Peter Brooks

    Palm Bay FL