It's great, we now have to stop using CE marks and use UKCA instead, but that's not accepted in Europe.
Except in Northern Ireland, where they still use CE but it has to be CE UKNI, which isn't acceptable in rUK or Europe. Nothing like regressing our medical device regulations by 30 years in order to take back control! #PraiseNigel
(The Porcupine From Purgatory we of all lost both have them, Wed 19 Apr 2023, 13:47, archived)

I wonder if you're aware of the rigorous testing standards for medical implant devices in the us?
Basically you can cobble anything together, and if you can successfully claim it was 'based upon' a formerly tested design, you don't need to do any testing at all. You just put it on the market, and surgeons start implanting it.
( mofaha ┐( ˘_˘)┌ ʅ(́◡◝)ʃ, Wed 19 Apr 2023, 13:56, archived)

I don't pretend to understand any of this really but from this distance it does look like NI is getting shafted
I can't think of a worse place in the uk to needlessly make things more difficult.
( mofaha ┐( ˘_˘)┌ ʅ(́◡◝)ʃ, Wed 19 Apr 2023, 14:08, archived)