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PART IIIU.K.Active Implantable Medical Devices

[F1Registration of persons placing active implantable medical devices on the marketN.I.

21B.—(1) Paragraph (2) applies—

(a)in relation to relevant devices other than custom-made devices, to—

(i)a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any relevant device;

F2(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv)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;

F3(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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)inform the Secretary of State of the address of their registered place of business; and

(b)supply the Secretary of State with a description of each category of device concerned;

F4(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)in the case of an authorised representative, supply the Secretary of State with—

(i)written evidence that they have been designated as an authorised representative;

(ii)details of the person who has so designated them; and

(iii)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)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 the date specified in paragraph (4).

(4) The obligations in paragraph (2) begin to apply on 1st May 2021.

F5(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments