Can anyone explain UKRP guidance relating to Northern Ireland?

Awadine

Starting to get Involved
#1
Hi

i have been looking through the MHRA registration guidance here.

For the GB market the guidance says:

Register your device to place on the Great Britain market
If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a place of business in the UK.

Manufacturers should appoint a UK Responsible Person as soon as possible.

For the NI market the guidance says:

Register your device to place on the Northern Ireland market
The manufacturer must appoint a UK Responsible Person that has a place of business in the UK, providing the following criteria apply. The manufacturer:
  • is based outside the UK
  • does not have a designated authorised representative - who has a place of business in Northern Ireland
  • is placing devices other than Class I or custom-made devices on the Northern Ireland market
Manufacturers must appoint a UK Responsible Person before they can place their device on the Northern Ireland market.

There is a clear distinction on timing of UKRP designation timeline. So for NI, UKRP must be in place before placing on NI market and for GB it’s only should be in place as soon as possible.

So my reading of this is that a US based manufacturer of Class IIa products with an Authorised Rep located in France must have a UKRP in place for product being placed in NI from 1 Jan 2021. But if they are only placing product in GB, not NI, the UKRP is only required ‘as soon as possible’.

Have I understood that correctly? I don’t understand why the UKRP would need to be in place for NI before GB so if anyone could explain that to me I would be really grateful.

many thanks.
 
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Alan_DB

Involved In Discussions
#2
Hi Awadine, I am not sure on the exact reason but its likely to do with NI market still being aligned with the EU, whereas GB is completely separate. Or else the MHRA have made a mistake in their guidance (which is not unknown).

Have you registered your product with MHRA for GB?
 

Awadine

Starting to get Involved
#3
Hi Alan. Thanks for your reply. We have registered with MHRA but I just wondered why the timelines would be different for our NI distributed product vs GB distributed product.

I guess it doesn’t make any practical difference - we have registered all product for the UK. But I was just curious why it would be different.

Thanks for your comments.
 
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