Hi all you wonderful people,
Does anyone have any experience in getting anything CE marked? The process I mean, not the physical application. I realise the UKCA will be applicable in the UK soon but first I need a CE and the documentation side is quite confusing.
I’ve worked on quite a few different medical devices that were CE marked, but wasn’t hugely involved with the actual certification process other that electrical and mexhanical safety testing.
Depending on the product you may well be able to self-certify, but you would need to be clear on the legal implications of doing this.
Can you tell us more about the product or is it all top secret??
Hi all, sorry about the delayed response.
My design is a purely mechanical lifting and quick release device with no electronics involved. I believe this will make certification and testing easier but it still looks like a minefield to navigate without professional assistance.
one of my friends needed to CE some of his products, you need to submit the plans, quote the applying patterns industrial standards and laws
if testing is done by a 3rd party (like TÜV NORD) attach their paperwork, user and maintenance manual, if mass produced the technological instruction, make the Conformity assessment procedure and attach that paperwork too, and have to make the Declaration of conformity by the regulations applying for that.
Email TÜV UK for assistance, they can help and do the testing.