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Joined: Aug 2019
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Howard Offline OP
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Having visited quite a few EBME departments recently, I wanted to make everyone aware of the new UKCA mark that will come into force on the 1st January 2022.

Medical devices maybe different, but certainly any test equipment that an EBME is looking to buy next year must confirm to the new mark.
The following is taken from the UK Gov site that talks about the UKCA mark.

UKCA marking has become mandatory following the end of the Brexit transition period although until 1 January 2022 the CE mark is accepted as a valid alternative. The scope and procedures of the UKCA scheme will initially follow those for CE marking, but after 31 December 2020 the two schemes may diverge.

More information can be found at
https://www.gov.uk/guidance/using-the-ukca-marking and other places on the Web.

If you are looking to buy, or plan to buy, its worth checking.

Comments......

Last edited by Howard; 16/07/21 2:41 PM.
1 member likes this: Dustcap
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Super Hero
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I think I preferred the BSI kite mark.

Just out of interest, do you know which UK Market Conformity Assessment Body has to be approached for "approval" of biomed test equipment, Howard (more than one, I'm guessing)? And how much does each "approval" cost?


If you don't inspect ... don't expect.

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