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Monday, 02/25/2019 9:48:26 AM

Monday, February 25, 2019 9:48:26 AM

Post# of 1742
This UK company received CE Approval 2 weeks ago.
https://www.medilinkem.com/surepulse-vs-achieves-ce-approval/

I've been doing a little digging on google 'CE Approval Brexit' and it appears that medical devices will continue to use the CE Approval

Link from Feb 2019
https://www.lexology.com/library/detail.aspx?g=a2a0485a-3bfc-44f5-8ae5-73400deb8e9a

The UK Conformity Assessed (UKCA) marking is the new UK product marking that, subject to parliamentary approval, will be used for certain categories of products being placed on the UK in the event of a no deal. As part of accelerated planning for a no-deal Brexit, on the 2 February 2019, the government published guidance on using the UKCA marking post 29 March 2018. The guidance does not cover construction products, medical devices or rail interoperability which have been dealt with separately.



Further down the article...

Next steps

The draft legislation implementing the new requirements is expected shortly. We expect this to have to go through the affirmative process of being debated in both the House of Commons and the House of Lords, as is the case with the draft medical device legislation. Interestingly, that legislation, less controversially and much to the medical device industry's relief, continues to recognise the CE mark for the foreseeable future and does not contain any provisions on the UKCA mark.

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