Need clarification on UKCA and "Approved Body"

Steve_in_MT

Starting to get Involved
#1
Thanks in advance for any help--I'm confused on exactly what is meant by getting a certificate from a UK "Approved Body" prior to applying the UKCA mark to a Class IIa medical device. Does that mean we need to use an entirely separate Notified Body that is based in the UK, and what exactly will they do? Will the perform an onsite audit (separate from the ISO/CE one)? Or would they do a Tech File review? And is an Approved Body the same as a Notified Body, but just the name for those in the UK?

Any thoughts would be greatly appreciated.
 
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Steve_in_MT

Starting to get Involved
#4
Thanks John--that's better than the other documents I've seen (one of which talked more about how it's okay to keep using the CE mark until the deadline). And maybe the details haven't been worked out, but HOW does one get the certificate--I see the choices for assessment routes, but what is involved (and I'm assuming it's the manufacturer and not the UK distributor/importer that needs to do it)? Are documents submitted to the Approved Body or is an on-site audit needed?
 

Philip B

Quite Involved in Discussions
#5
Steve - do you have a current MDD certificate with an EU NB that is also a UK AB? If so, obtaining a UKCA mark is relatively straightforward, as UKCA is based on the MDD not the MDR and providing you are up to date with your MDD audits and tech file reviews and have no major NCs outstanding then the process should be a desk review and not require any auditing (that's been the case with us anyway). If you are not currently with a UK AB then you might have to go through full conformity assessment with one. Best to contact the UK ABs (I think there are only three) and see what they say.
 
#6
This pdf based on a webinar from the BSI may be helpful:

*https://www.swiss-medtech.ch*/sites/default/files/2021-06/Presentation%20by%20Maddalena%20Pinsi%20and%20Jayanth%20Katta.pdf

Further on from what Philip B has stated, does this refer to BSI 2797? I am drafting a DoC for the UK CA marking and have put BSI 0086 as the NB (as I was assuming this is the correct one) but I was told that BSI 2797 can do this. Has anyone seen this being the case? I find it quite confusing as they are not UK based. I have also been told to refer to the MDD in the draft, even though the UK and CE DoC are separate (though I know that for the interim, MDD can be the basis for conformity in the UK up until 1st Jan 2023)- I was drafting the DoC to mention only UK MDR and associated standards.

I would be grateful if anyone else has any thoughts on this
 

Philip B

Quite Involved in Discussions
#7
2797 is the designation for BSi as an EU notified body. 0086 is the designation for BSi as a UK approved body. You obtain the CE mark via 2797 and the UKCA mark via 0086. Our UKCA DoC refers to the Medical Devices Regulation 2002 (UK MDR 2002) as the underpinning legislation but to Annex V of MDD 93/42/EEC for the conformity assessment route. This has been accepted by our AB.
 

Steve_in_MT

Starting to get Involved
#8
Thanks Philip. Unfortunately our NB is not one of the UK ABs, but I will check to see if maybe they are planning to do so. It would be hard to justify having a separate conformity assessment if it had to be done on-site. As you suggest, I can also check with the ones that are UK ABs and see what they say. Thanks!
 
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