Informational UK guidance on Device regulation from Jan 2021 published

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chris1price

Trusted Information Resource
#3
I am glad Brexit was supposed to reduce red-tape. Otherwise I would have sworn this document says we need to have two certification processes, one for UK and one for EU. (and possibly a third for Northern Ireland).

Text such as this worry me:
"We are committed to improving the standards and scrutiny of medical devices that reach UK patients. This will be enabled through the powers currently being created through the Medicines and Medical Devices Bill. ……..We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that puts patient safety at the heart of the regulatory system. We will take into consideration international standards and global harmonisation in the development of our future system."

I would love to think they will copy/paste the MDR, but I worry they hall come up with something altogether new. It looks like Regulatory Affairs staff will have vital jobs for the foreseeable future. Sorry rant over.
 

Michael Ayers

Starting to get Involved
#9
I am glad Brexit was supposed to reduce red-tape. Otherwise I would have sworn this document says we need to have two certification processes, one for UK and one for EU. (and possibly a third for Northern Ireland).
I think the idea is not to reduce red tape, rather just to cover it with red, white and blue tape.

From my understanding, until 2023, manufacturers will still be able to obtain CE marks by following the new EU MDR and be able to place on the UK market. Alternatively, they can follow the UK 2002 Medical Device Regulations (which by the end of this year, will likely be updated to have the same wording as the new EU MDR). Presumably, for in-house manufactured and custom devices without a CE mark, manufacturers will have to be complying with the UK 2002 Medical Device Regulations in whatever form they take by the end of this year.

Over time, we may see divergence between the EU and the UK regulations. Essentially, the two sets of tape would unravel, causing manufacturers to have to follow two different regimes.
 

twanmul

Involved In Discussions
#10
Thanks for this. There is a bit of confusion for me with this at the moment. The guidance says the following:
"From 1 July 2023, to place a device on the Great Britain market, you will need to meet the requirements for placing a UKCA mark on your device."

My inference from this is that; assuming "placing on the market" is consistent with the existing definition within the EU directives ('placing on the market` means the first making available in return for payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the ... market, regardless of whether it is new or fully refurbished), does this mean that anything which is already placed into service in the UK market prior to 1st July 2023 bearing only a CE mark (i.e. existing devices already registered with the MHRA) will not need to have a UKCA mark placed on the device and acceptable on or after 1st July 2023?

Is my inference correct or am I being literal and the implication from the guidance was supposed to be that anything only the market (whether first making available or something already available) will need the UKCA mark?

Any thoughts appreciated.
 
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