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?