CHAPTER IV

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Approval
Article 22
1
The Secretary of State may approve bodies to carry out third-party conformity assessment tasks under this Regulation.
2
The Secretary of State must—
a
assign an approved body identification number to each approved body;
b
compile and maintain a register of approved bodies containing in relation to each body—
i
the approved body identification number,
ii
details of the activities for which the body is approved, and
iii
any restrictions on the activities for which the body is approved.
3
The register referred to in paragraph 2 must be made publicly available.

Notifying authorities
Article 23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements relating to notifying authorities
Article 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information obligation on notifying authorities
Article 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements relating to approved bodies
Article 26
1
For the purposes of approval, a conformity assessment body shall meet the requirements laid down in paragraphs 3 to 10.
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
A conformity assessment body shall be a third-party body independent of the organisation or the subsystem or the safety component 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 subsystems or safety components 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 subsystems or the safety components which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed subsystems or safety components that are necessary for the operations of the conformity assessment body or the use of such subsystems or safety components 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, marketing, installation, use or maintenance of those subsystems or safety components, 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 notified. 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 Annexes III to VII and in relation to which it has been notified, 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 subsystems or safety components in relation to which it has been notified, 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 a notified 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 subsystem or safety component 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 notified;
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 II, of the applicable designated standards and of the relevant provisions of this Regulation and of the Cableway Installations Regulations 2018;
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, nor on the results of those assessments.
9
Conformity assessment bodies shall take out liability insurance ....
10
The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII ..., except in relation to the Secretary of State or the Executive. Proprietary rights shall be protected.
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Presumption of conformity of notified bodies
Article 27
1
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements.
2
In paragraph 1, expressions used are to be given the same meaning as in the EU Regulation.

Subsidiaries of and subcontracting by approved bodies
Article 28
1
Where an approved body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 26 and shall inform the Secretary of State accordingly.
2
Approved bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
3
Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
4
Approved bodies shall keep at the disposal of the Secretary of State the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII.

Application for approval
Article 29
1
A conformity assessment body shall submit an application for approval to the Secretary of State.
2
The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the subsystem/safety component or subsystems/safety components for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by the United Kingdom Accreditation Service attesting that the conformity assessment body fulfils the requirements laid down in Article 26.
3
Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 26.

Notification procedure
Article 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Identification numbers and lists of notified bodies
Article 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes to approvals
Article 32
1
Where the Secretary of State has ascertained or has been informed that an approved body no longer meets the requirements laid down in Article 26 or that it is failing to fulfil its obligations, the Secretary of State shall restrict, suspend or withdraw the approval, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. ...
2
In the event of restriction, suspension or withdrawal of notification, or where the approved body has ceased its activity, the Secretary of State shall take appropriate steps to ensure that the files of that body are either processed by another approved body or kept available for the Secretary of State and the Executive at their request.

Challenge of the competence of notified bodies
Article 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operational obligations of approved bodies
Article 34
1
Approved bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII.
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 subsystem or safety component 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 subsystem or the safety component with this Regulation.
3
Where an approved body finds that the essential requirements set out in Annex II or corresponding designated 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, an approved body finds that a subsystem or a safety component 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 approved body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

Appeal against decisions of approved bodies
Article 35
Approved bodies shall ensure that an appeal procedure against their decisions is available.

Information obligation on approved bodies
Article 36
1
Approved bodies shall inform the Secretary 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 approval;
c
any request for information which they have received from the Executive regarding conformity assessment activities;
d
on request, conformity assessment activities performed within the scope of their approval and any other activity performed, including cross-border activities and subcontracting.
2
Approved bodies shall provide the other bodies approved under this Regulation carrying out similar conformity assessment activities covering the same subsystems or safety components with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Exchange of experience
Article 37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Coordination of notified bodies
Article 38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 22 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 31; 2020 c. 1, Sch. 5 para. 1(1)
Arts. 23-25 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 32; 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 26 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(a); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 26(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 26(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Art. 26(2) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(c); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 26(7)(c) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 26(9) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(e); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 26(10) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(f)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 26(10) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Art. 26(11) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(g); 2020 c. 1, Sch. 5 para. 1(1)
Art. 27 renumbered as Art. 27(1) (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 34(a); 2020 c. 1, Sch. 5 para. 1(1)
Art. 27(2) inserted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 34(b); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 28 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 28(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 28(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 28(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(c); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 28(4) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(d)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 28(4) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 29(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 29(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 29(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(c); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 29 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(a); 2020 c. 1, Sch. 5 para. 1(1)
Art. 30 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 37; 2020 c. 1, Sch. 5 para. 1(1)
Art. 31 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 37; 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 32 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(1) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(v); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Art. 33 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 39; 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 34 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 34(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 34(3) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 34(3) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 34(4) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 34(5) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(e); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 35 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 41(a); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 35 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 41(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 36 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 36(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 36(1)(b) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 36(1)(c) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 36(1)(d) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 36(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 36(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 36(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Art. 37 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 43; 2020 c. 1, Sch. 5 para. 1(1)
Art. 38 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 43; 2020 c. 1, Sch. 5 para. 1(1)