# The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Paragraph 16: Insertion of regulations 16A to 16C


Before regulation 17 insert—
“Approved bodies
16A. (1) An approved body is a person who—
(a) on or after exit day has been designated to carry out conformity assessment in accordance with regulation 16B, to the extent that the designation remains in effect; or
(b) immediately before exit day was a UK notified body.
(2) Paragraph (1) is subject to regulation 17.
(3) In this Part a “UK notified body” means a person who immediately before exit day was a UK notified body as defined in regulation 16(3) of these Regulations as they had effect immediately before exit day.
Approved body designation
16B. (1) The Secretary of State may only designate a person to carry out conformity assessment if that person qualifies for approval.
(2) A person qualifies for approval if the Secretary of State—
(a) is satisfied that the person meets the criteria specified in Annex XI (Part 11 of Schedule 2) (“approved body criteria”); and
(b) makes a designation in respect of that person (an “approved body designation”).
(3) Where a person meets the assessment criteria laid down in a designated standard (or part of such a standard) the Secretary of State is to presume that the person meets the approved body criteria covered by that standard (or that part of that standard).
(4) Where the Secretary of States makes an approved body designation, that designation—
(a) must be in writing;
(b) must specify the conformity assessment procedures that the person designated may carry out;
(c) may relate to all the categories of machinery listed in Annex IV (Part 4 of Schedule 2) or to such of those categories as are specified in the designation;
(d) may designate a person for a specified period; and
(e) may be made subject to such other conditions as are specified in the designation, including conditions which are to apply upon or following termination of the designation.
(5) In making an approved body designation the Secretary of State may have regard (in addition to the approved body criteria) to any other matter which appears to the Secretary of State to be relevant.
(6) Where an approved body was a UK notified body immediately before exit day, an “approved body designation” means a notified body designation within the meaning of regulation 16(2) and (4) of these Regulations, as they had effect immediately before exit day.
Monitoring
16C. (1) The Secretary of State must, from time to time, carry out an inspection of each approved body with a view to verifying that it—
(a) meets the approved body criteria;
(b) complies with any condition to which its designation is subject—
(i) in accordance with regulation 16B(4)(e);
(ii) in the case of an approved body which was a UK notified body immediately before exit day, in accordance with regulation 16(8)(e) as it applied before exit day; and
(c) complies with these Regulations.
(2) An approved body must comply with any request of the Secretary of State to provide information relevant to determining its compliance with the approved body criteria, these Regulations, or any condition to which its designation is subject.”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111180402/schedule/12/paragraph/16 (the official version)
Page: https://openlegislation.uk/draft-product-safety-and-metrology-etc-amendment-etc-eu-exit-regulations-2019/schedule-12/paragraph-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.