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PART 2Provisions in respect of MRAs

Recognition of conformity assessment

4.—(1) Paragraph (2) applies where, pursuant to an MRA, the United Kingdom is required to recognise or accept a conformity assessment procedure performed or a conformity assessment result issued by an MRA body in respect of a product, process or service to which the specified Regulations apply (a “mutually recognised procedure or conformity assessment result”).

(2) For the purpose of the specified Regulations which are referred to in paragraph (1), the mutually recognised procedure or conformity assessment result is to be treated as if it were performed or issued by an approved body.

Registers of MRA bodies and UK-recognised Canadian accreditation bodies

5.—(1) The Secretary of State may—

(a)assign an identification number to each MRA body (an “MRA body identification number”);

(b)compile and maintain a register of—

(i)MRA bodies;

(ii)their MRA body identification numbers;

(iii)the activities for which they have been designated; and

(iv)any restriction on those activities; and

(c)compile and maintain a register of—

(i)UK-recognised Canadian accreditation bodies;

(ii)the specified Regulations for which they have been recognised; and

(iii)any restriction on their accreditation activities.

(2) Any register referred to in paragraph (1) must be made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the registers referred to in paragraph (1).

Designation of UK bodies

6.—(1) The Secretary of State may designate for the purpose of an MRA a conformity assessment body to perform conformity assessment procedures against the legislative, regulatory and administrative requirements of the other Party that are set out in or relate to products specified in an annex or appendix to an MRA listed in Schedule 2 (referred to in this regulation as a “designated body”) and any such designation must include the scope of the activities for which the body is designated.

(2) A body may be designated under paragraph (1) only if the Secretary of State considers that the body is capable of fulfilling the functions of and meets the requirements for a designated body arising out of the MRA (referred to in this regulation as having “designated capability”).

(3) For the purposes of paragraph (2), subject to paragraph (4), the Secretary of State may accept a certificate or schedule, issued by the United Kingdom Accreditation Service, attesting that a conformity assessment body has designated capability, as sufficient evidence that the conformity assessment body has designated capability.

(4) In relation to designation under the Canadian MRA, for the purposes of paragraph (2), where the United Kingdom Accreditation Service has not been recognised by Canada under the Canadian MRA as competent to provide the certificate or schedule referred to in paragraph (3), the Secretary of State may accept an attestation that a conformity assessment body has designated capability issued by another accreditation body as sufficient evidence that the conformity assessment body has designated capability, provided that other accreditation body has been duly recognised by Canada as competent to issue such attestation.

(5) The Secretary of State must monitor each designated body with a view to verifying that the designated body continues to have designated capability.

(6) The Secretary of State may vary the scope of the activities for which the designated body has been designated.

(7) The Secretary of State may restrict, suspend or withdraw any designation of a body under paragraph (1) if—

(a)the body so requests;

(b)the Secretary of State considers that the body no longer has designated capability; or

(c)the Secretary of State is required to do so under the MRA.

(8) Before—

(a)effecting a variation under paragraph (6); or

(b)restricting, suspending or withdrawing a designation under paragraph (7), otherwise than at the designated body’s request or when required to do so under the MRA,

the Secretary of State must notify and give to the designated body an opportunity to make representations within a reasonable period from the date of the notice and consider any such representations made by the designated body.

(9) The Secretary of State may compile and maintain a register of designated bodies and the activities for which they have been designated.

(10) The Secretary of State may authorise the United Kingdom Accreditation Service to carry out the following activities under this regulation on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body has designated capability;

(b)monitoring designated bodies in accordance with paragraph (5); or

(c)compiling and maintaining the register of designated bodies in accordance with paragraph (9); and

(d)verifying that the accreditation body referred to in paragraph (4) has been duly recognised by Canada.

Disclosure of information pursuant to an MRA

7.—(1) The Secretary of State, or a person authorised to act on behalf of the Secretary of State, may disclose relevant information to the other Party.

(2) A disclosure made in accordance with paragraph (1) does not breach any obligation of confidence owed by the Secretary of State.

(3) Nothing in this regulation authorises a disclosure of information which contravenes the data protection legislation (but in determining whether a disclosure would do so, the powers conferred by this regulation are to be taken into account).

(4) In this regulation—

“the data protection legislation” has the same meaning as in the Data Protection Act 2018 (see section 3 of that Act)(1);

“relevant information” means information that the United Kingdom is required to disclose to the other Party under an MRA.

(1)

2018 c. 12. There are amendments to this Act but none are relevant to these Regulations.