> Only very high risk items in the CE scheme actually need checks by a third party It's not just pacemakers, pretty much the whole PPE category requires inspec

> Only very high risk items in the CE scheme actually need checks by a third party It's not just pacemakers, pretty much the whole PPE category requires inspection by independent third parties (notified bodies). That's obvious stuff like climbing gear and equipment for work at height, maybe less so for certain gloves, helmets, eyewear, carabiners, rope, etc. Compare the checks for climbing rope, and the whole EN/US scheme is inverted. We have so few standards in the US market that we just piggyback on theirs.