# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, 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).”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/1/paragraph/7 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-1/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.