Insertion of regulation 19B
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Memorandwm Esboniadol
7. After regulation 19 insert—
“Requirement to appoint a UK responsible person for general medical devices
19B.—(1) Paragraph (2) applies in relation to a manufacturer who—
(a)does not have a registered place of business in the United Kingdom;
(b)has not designated an authorised representative who has a registered place of business in Northern Ireland; and
(c)places a relevant device, other than a Class I or custom-made device, on the market in Northern Ireland.
(2) A manufacturer to whom this paragraph applies must appoint a person with a registered place of business in the United Kingdom as their UK responsible person to carry out the tasks described in regulations 19(2) and (5).”.