# The Medical Devices (Amendment) (EU Exit) Regulations 2021, Paragraph 26


In Article 5 (surveillance and monitoring)—
(a) in paragraph 1—
(i) for “notified” in each place it occurs, substitute “approved”,
(ii) in the first sub-paragraph, for “designating authority of the Member State where the notified body is established” substitute “Secretary of State”,
(iii) in the third sub-paragraph, for “That designating authority” substitute “The Secretary of State”;
(b) in paragraph 2, for “designating authorities”, substitute “Secretary of State”;
(c) in paragraph 3—
(i) for the first sub-paragraph substitute—
“The Secretary of State shall continuously monitor that body to ensure ongoing compliance with the applicable requirements. The Secretary of State shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from outside the United Kingdom, which might indicate the non-fulfilment of the obligations by an approved body or its deviation from common or best practice.”,
(ii) in the second sub-paragraph, for “designating authority of the Member State where the notified body is established” substitute “Secretary of State”.

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Source: https://www.legislation.gov.uk/uksi/2021/873/schedule/2/paragraph/26 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-2/paragraph-26
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.