Paragraph 7 Insertion of regulation 19B

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).”.