Brexit When does the UK responsible person need to be in place?

[Awadine]

Can anyone clear up my confusion on the UK responsible person.

There are grace periods for registering products, but do the grace periods also apply to assigning the UK RP? Or is the UK RP required to be designated for 1 Jan 2021?

The guidance isn’t really explicit on this point (as far as I have seen). But the UK exit regulations do suggest UK RP would need to be in place for Jan 1 2021.

 

[twanmul]

It says in the draft legislation:
" (4) The obligations in paragraph (2) begin to apply—
(a)where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1 January 2021;
(b)in circumstances other than those described in sub-paragraph (a)—
(i)in the case of a relevant device that is a List A device, on 1st May 2021;
(ii)in the case of a relevant device that is a device for self-testing, on 1st September 2021; and
(iii)in the case of a relevant device that is a List B device, on 1st September 2021."

All requirements for UK RP in the draft legislation link back to paragraph 2 and therefore; unless you're "placing devices" on the market in Northern Ireland (where you will need some representation from 1st January), the grace periods apply for designating a UK RP (from what I can see anyway).

 

[Awadine]

It says in the draft legislation:
" (4) The obligations in paragraph (2) begin to apply—
(a)where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1 January 2021;
(b)in circumstances other than those described in sub-paragraph (a)—
(i)in the case of a relevant device that is a List A device, on 1st May 2021;
(ii)in the case of a relevant device that is a device for self-testing, on 1st September 2021; and
(iii)in the case of a relevant device that is a List B device, on 1st September 2021."

All requirements for UK RP in the draft legislation link back to paragraph 2 and therefore; unless you're "placing devices" on the market in Northern Ireland (where you will need some representation from 1st January), the grace periods apply for designating a UK RP (from what I can see anyway).

Thanks!

For general medical devices (not IVDs) my reading of the amendments is that the contents ‘substitution of regulation 19’ (registration of persons placing medical devices on the market) would apply to registration of devices and there’s a similar entry on timing

(4) The obligations in paragraph (2) begin to apply—
(a)in the case of a device that is a Class I device, on 1st January 2021;
(b)in the case of a device that is a Class III or IIb implantable device, on 1st May 2021;
(c)in the case of a device that is a Class IIa or Class IIb non-implantable device, on 1st September 2021

which makes sense for the actual registration of the device.

But I thought a separate registration was needed for the UK RP. One UK RP might be responsible for multiple device classes for example.

Questions:
1.Even if there’s no requirement to register a device/responsible person until the grace periods end, does that mean that a UK RP is not needed to be designated prior to deadlines for registration?

2. Who are MHRA going to hold accountable for products placed on the UK market post Jan 1 if there’s no UK RP in place, whether or not they are registered with MHRA?

 

[Rincewind]

Hello,
can we already designate an UK Rep right now and if yes, where would you do this? I couldn't find a form or anything on the MHRA website.
My understanding is that we need a contract with the UK Rep. and the UK Rep himself will then register with MHRA for our products.

I was also sligthly confused by an Emergo article where they said that the UK Rep also has to be the importer of the devices into the UK. Is this correct?

 

[Awadine]

It’s not correct that the importer and UK RP have to be the same entity. I am sure I have seen this stated somewhere. My understanding is that the I importer would be required to inform the UK RP they intended to import product.

 

[Rincewind]

I am wondering how exactly you register the UK Rep. I mean actually where? If I look at the MHRA webpage and database it only allows registration as manufacturer but not as a UK Rep from 01.01.2021.

Does anyone know where to exactly do that?

 

[Awadine]

I would guess that there will be some guidance coming from MHRA on this point. I was imagining that they might use the existing manufacturer or Authorised Rep registration functionality. But I am not sure how that would work.

 

[Marc]

...,It says in the draft legislation:...

It will greatly help if posters will cite what specific legislation is being referred to.

Thanks

 

[Rincewind]

I would guess that there will be some guidance coming from MHRA on this point. I was imagining that they might use the existing manufacturer or Authorised Rep registration functionality. But I am not sure how that would work.

Hello, I thought the same thing but different consulting companies (in Webinars I attended) said they are already registered as a UK-Rep, this what got me wondering.

 

[Awadine]

For class I devices it would be possible to register I guess. You would just follow the “manufacturer” pathway.