UKCA Marking of a MDR Class IIa Device

[dj123]

Hi all.

I am currently putting through a set of devices that were Class I and are now Class IIa under the MDR; they are currently self-certified and marked as UKCA and CE under the premise that they are Class I. My query is how, if at all, we would be able to maintain dual marking once this submission was approved?

• If we are putting them into the UK market under MDR compliance as IIa, would we have to remove the UKCA mark as it's now classified as Class IIa and would need UKAB authorisation, or
• Could we maintain a UKMDR tech file and have a specific DoC just for UKCA marking purposes as Class I, or
• Am I way of the mark??!

Thanks

 

[Orca1]

It seems that you would need to maintain separate technical files and DoC for each marking (CE and UKCA), ensuring that each file and DoC meets the specific requirements of the respective regulatory bodies.