CHAPTER IVU.K. [F1APPROVAL OF CONFORMITY ASSESSMENT BODIES]

[F2Article 19U.K.Approved bodies

1.An approved body is a conformity assessment body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in Article 20 (approval of conformity assessment bodies); or

(b)immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under Article 29 (changes to notifications) of Regulation 2016/426 (pre-exit), to suspend or withdraw the body's status as a notified body.

2.Paragraph 1 has effect subject to Article 29 (restriction, suspension or withdrawal of approval).

3.In this Chapter—

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[F3Article 20U.K.Approval of conformity assessment bodies

1.The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

2.A conformity assessment body qualifies for approval if the first and second conditions below are met.

3.The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; and

(iii)the category of appliance or fitting in respect of which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate; or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

4.The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

5.For the purposes of paragraph 4, the Secretary of State may accept an accreditation certificate provided in accordance with paragraph 3(b)(i), as sufficient evidence that the conformity assessment body meets the approved body requirements.

6.When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

7.For the purposes of this Article, “accreditation certificate” means a certificate issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.]

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[F4Article 21U.K.UK national accreditation body

The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements;

(b)monitoring approved bodies in accordance with Article 22; and

(c)compiling and maintaining the register of approved bodies, in accordance with Article 28.]

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[F5Article 22U.K.Monitoring obligations

The Secretary of State must monitor each approved body with a view to verifying that the body—

(a)continues to meet—

(i)the approved body requirements;

(ii)any conditions set by the Secretary of State under Article 20(6)(b); and

(b)carries out its functions in accordance with this Regulation.]

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Article 23U.K.[F6Approved Body Requirements]

1.For the purposes of [F7approval], a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

[F82.A conformity assessment body must have legal personality and must be established in—

(a)the United Kingdom; or

(b)the territory of a party to the CPTPP.]

[F92A.In paragraph (2) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.]

3.A conformity assessment body shall be a third-party body independent of the organisation or the appliance or the fitting it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of appliances or fittings which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4.A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the appliances or the fittings which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed appliances or fittings that are necessary for the operations of the conformity assessment body or the use of such appliances or fittings for personal purposes.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those appliances or fittings, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are [F10approved]. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annex III and in relation to which it has been [F11approved], whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times, and for each conformity assessment procedure and each kind or category of appliances or fittings in relation to which it has been [F11approved], a conformity assessment body shall have at its disposal the necessary:

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as [F12an approved body] and other activities;

(c)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the appliance or fitting technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7.The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been [F13approved];

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential requirements set out in Annex I, of the applicable [F14designated] standards and of the relevant provisions of [F15this Regulation and any other relevant United Kingdom legislation];

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8.The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9.Conformity assessment bodies shall take out liability insurance unless [F16the Secretary of State] is directly responsible for the conformity assessment.

10.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annex III or any provision of [F17United Kingdom] law giving effect to it, except in relation to the [F18enforcement authority]. Proprietary rights shall be protected.

11.Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of [F19any approved] body coordination group established [F20by the Secretary of State] and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

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[F21Article 24U.K.Presumption of conformity of approved bodies

1.Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such a standard), the Secretary of State must presume that the conformity assessment body meets the approved body requirements covered by that standard (or the part of that standard).

2.The presumption in paragraph 1 is rebuttable.]

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[F22Article 25U.K.Subsidiaries of, and subcontracting by, approved bodies

1.An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a)the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b)the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c)the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

2.The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

3.Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activity carried out by the subcontractor or subsidiary.

4.In this Article, “subsidiary” has the meaning given to it by section 1159 of the Companies Act 2006.]

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F23Article 26U.K.Application for notification

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F24Article 27U.K.Notification procedure

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[F25Article 28U.K.Identification numbers and register of approved bodies

1.The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification numbers;

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

(iv)any restrictions on those activities.

2.The register referred to in paragraph 1 must be made publicly available.]

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[F26Article 29U.K.Restriction, suspension or withdrawal of approval

1.Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in Article 20(6)(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under Article 20.

2.Where the Secretary of State determines that an approved body no longer meets a condition referred to in Article 20(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under Article 20.

3.In deciding what action to take under paragraph 1 or 2, the Secretary of State must have regard to the seriousness of the non-compliance.

4.Before taking action under paragraph 1 or 2, the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

5.Where the Secretary of State has taken action in respect of an approved body under paragraph 1 or 2, or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a)transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b)keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and market surveillance authority for a period of 10 years from the date they were created.

6.The activities undertaken as an approved body referred to in paragraph 5 include any activities that the body has undertaken as a notified body.]

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F27Article 30U.K.Challenge of the competence of notified bodies

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Article 31U.K.Operational obligations of [F28approved] bodies

1.[F29Approved] bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annex III.

[F301A.Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures in respect of which —

(a)the body's approval was given under Article 20; or

(b)the body's notification as a notified body was made.]

2.Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.

Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the appliance or fitting technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the appliance or the fitting with this Regulation.

3.Where [F31an approved] body finds that the essential requirements set out in Annex I or corresponding [F32designated] standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.

4.Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, [F33an approved] body finds that an appliance or a fitting no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision, if necessary.

5.Where corrective measures are not taken or do not have the required effect, the [F34approved] body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

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Article 32U.K.Appeal against decisions of [F35approved] bodies

[F36Approved] bodies shall ensure that an appeal procedure against their decisions is available.

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Article 33U.K.Information obligation on [F37approved] bodies

1.[F38Approved] bodies shall inform the [F39Secretary of State] of the following:

(a)any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

(b)any circumstances affecting the scope of or the conditions for [F40their approval];

(c)any request for information which they have received from [F41the market surveillance authority] regarding conformity assessment activities;

(d)on request, conformity assessment activities performed within the scope of their [F42approval] and any other activity performed, including cross-border activities and subcontracting.

2.[F43Approved] bodies shall provide [F44other approved bodies] under this Regulation carrying out similar conformity assessment activities covering the same appliances or fittings with relevant information on issues relating to negative and, on request, positive conformity assessment results.

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F45Article 34U.K.Exchange of experience

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F46Article 35U.K.Coordination of notified bodies

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