SCHEDULE 1
Regulation 2
Amendment of the Medical Devices Regulations 2002
1 The Medical Devices Regulations 2002 are amended in accordance with this Schedule.
2 Amendment of regulation 2
In regulation 2 (interpretation)—
a for the definition of “authorised representative” substitute—
““authorised representative” means a person established within a relevant state, explicitly designated by the manufacturer who is not a person established in a relevant state, who acts for the manufacturer and may be addressed by authorities and bodies in a relevant state instead of the manufacturer with regard to the latter’s obligation under Directive 90/385, Directive 93/42 and Directive 98/79;”;
b in the definition of “EC CAB” omit “EC”;
c in the definition of “intended for clinical investigation”, in paragraph (b) for “Member State” substitute “relevant state”;
d in the definition of “national standard” for “a Member State of the Community” substitute “a relevant state”;
e in the definition of “placing on the market”, for “the Community market” substitute “a relevant market”;
f in paragraph (b) of the definition of “putting into service” for “the Community” substitute “a relevant state”;
g in the appropriate places insert—
““relevant market” means a market of a relevant state;”;
““relevant state” means—
(a) in relation to any requirement relating to anin vitro diagnostic medical device, Northern Ireland or a Member State of the European Union;
(b) in relation to any requirement relating to any other medical device, Northern Ireland or a state in the European Economic Area;
(c) a State other than a Member State of the European Union which is a Party to an Association Agreement (where applicable under that Association Agreement);”;
““UK mutual recognition agreement” means an agreement between the United Kingdom and another country that covers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of the conformity assessment procedures undertaken by each other’s designated bodies;”;
““UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) indication) (EU Exit) Regulations 2020;”;
““UK responsible person” is to be construed in accordance with regulation 19B(2) for the purposes of Part II, regulation 21C(2) for the purposes of Part III and regulation 44A(2) for the purposes of part IV.”.
3 Insertion of regulation 10A
After regulation 10 (CE marking of general medical devices) insert—
“UK(NI) indication: general medical devices
10A. (1) Where the CE marking referred to in regulation 10 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.
(2) The UK(NI) indication must be affixed—
(a)
(a) visibly, legibly and indelibly; and
(b)
(b) before a relevant device is placed on the market in Northern Ireland.
(3) The UK(NI) indication must accompany the CE marking, wherever such marking is affixed in accordance with regulation 13.
(4) The UK(NI) indication must be affixed by the manufacturer.
(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.
(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.”.
4 Amendment of regulation 16
In regulation 16(1) (procedures for general medical devices for clinical investigations), for “the United Kingdom” substitute “Northern Ireland”.
5 Amendment of regulation 17
In regulation 17 (manufacturers etc and conformity assessment procedures for general medical devices) omit paragraph (3).
6 Substitution of regulation 19
For regulation 19 (registration of persons placing general medical devices on the market) substitute—
“Registration of persons placing general medical devices on the market
19. (1) Paragraph (2) applies—
(a)
(a) in relation to relevant devices that are neither Class I devices nor custom-made devices, to—
a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any general medical device of any class, other than a system or procedure pack which is not CE marked;
a UK responsible person;
a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;
a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;
(b)
(b) in relation to Class I devices and custom-made devices, to—
a manufacturer who places a device on the Northern Ireland market and has a registered place of business in Northern Ireland;
an authorised representative with a registered place of business in Northern Ireland;
(c)
(c) to a person with a registered place of business in Northern Ireland who sterilises before use any devices designed by their manufacturer to be sterilised before use.
(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—
(a)
(a) inform the Secretary of State of their address and registered place of business;
(b)
(b) supply the Secretary of State with a description of each category of device concerned;
(c)
(c) in the case of a UK responsible person, supply the Secretary of State with—
written evidence that they have been appointed as a UK responsible person;
details of the person who has so appointed them; and
where the person placing the devices concerned on the market is neither the manufacturer nor the UK responsible person, the name and address of the registered place of business of the person placing the devices concerned on the market;
(d)
(d) in the case of an authorised representative, supply the Secretary of State with—
written evidence that they have been designated as an authorised representative;
details of the person who has so designated them; and
where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;
(e)
(e) inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.
(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.
(4) The obligations in paragraph (2) begin to apply—
(a)
(a) in the case of a device that is a Class I device and custom-made devices, on 1st January 2021;
(b)
(b) in the case of a...
