PART 2U.K.Operational obligations of notified bodies
17. [F1An approved] body must carry out conformity assessments in accordance with the conformity assessment procedures.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Words in Sch. 4 para. 17 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
17. A notified body must carry out conformity assessments in accordance with the conformity assessment procedures.
Extent Information
E13This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
18. [F2An approved] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.
Extent Information
E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F2Words in Sch. 4 para. 18 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
18. A notified body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.
Extent Information
E14This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
19. [F3An approved] body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the vessel technology in question and the mass or serial nature of the production process.
Extent Information
E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F3Words in Sch. 4 para. 19 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
19. A notified body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the vessel technology in question and the mass or serial nature of the production process.
Extent Information
E15This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
20. [F4An approved] body must respect the degree of rigour and the level of protection required to ensure that the vessel is in conformity with the requirements of these Regulations.
Extent Information
E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F4Words in Sch. 4 para. 20 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
20. A notified body must respect the degree of rigour and the level of protection required to ensure that the vessel is in conformity with the requirements of these Regulations.
Extent Information
E16This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
21. Where [F5an approved] body finds that essential safety requirements or corresponding [F6designated] standards or other technical specifications have not been met by a manufacturer, it must require the manufacturer to take appropriate corrective measures and must not issue a certificate of conformity.
Extent Information
E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F5Words in Sch. 4 para. 21 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F6Word in Sch. 4 para. 21 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(e) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
21. Where a notified body finds that essential safety requirements or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it must require the manufacturer to take appropriate corrective measures and must not issue a certificate of conformity.
Extent Information
E17This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
22. Where, in the course of the monitoring of conformity following the issue of a certificate of conformity, a notified body finds that a vessel is no longer in conformity with the essential safety requirements, it must require the manufacturer to take appropriate corrective measures and must, if necessary, suspend or withdraw the certificate of conformity.U.K.
23. Where the [F7approved] body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the notified body must restrict, suspend or withdraw any certificate of conformity.
Extent Information
E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F7Word in Sch. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(b) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
23. Where the notified body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the notified body must restrict, suspend or withdraw any certificate of conformity.
Extent Information
E18This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
24. Paragraph 25 applies where [F8an approved] body is minded to—
(a)refuse to issue a certificate of conformity;
(b)restrict, suspend or withdraw a certificate of conformity.
Extent Information
E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F8Words in Sch. 4 para. 24 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
24. Paragraph 25 applies where a notified body is minded to—
(a)refuse to issue a certificate of conformity;
(b)restrict, suspend or withdraw a certificate of conformity.
Extent Information
E19This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
25. Where this paragraph applies, the [F7approved] body must—
(a)give the person applying for the certificate of conformity, or the person to whom the certificate of conformity has been given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;
(b)give the person referred to in sub-paragraph (a), an opportunity to make representations within a reasonable period from the date of the notice;
(c)take account of any representations made within the period referred to in subparagraph (b) before taking its decision.
Extent Information
E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F7Word in Sch. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(b) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
25. Where this paragraph applies, the notified body must—
(a)give the person applying for the certificate of conformity, or the person to whom the certificate of conformity has been given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;
(b)give the person referred to in sub-paragraph (a), an opportunity to make representations within a reasonable period from the date of the notice;
(c)take account of any representations made within the period referred to in subparagraph (b) before taking its decision.
Extent Information
E20This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
26. [F9An approved] body must inform the Secretary of State of—
(a)any refusal, restriction, suspension or withdrawal of a certificate of conformity;
(b)any circumstances affecting the scope of or conditions for notification under regulation 46 F10...;
(c)any request for information which it has received from a market surveillance authority regarding conformity assessment activities;
(d)on request, any conformity assessment activities performed within the scope of its notification under regulation 46 and any other activity performed, including cross-border activities and subcontracting.
Extent Information
E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F9Words in Sch. 4 para. 26 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F10Word in Sch. 4 para. 26(b) omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(f) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
26. A notified body must inform the Secretary of State of—
(a)any refusal, restriction, suspension or withdrawal of a certificate of conformity;
(b)any circumstances affecting the scope of or conditions for notification under regulation 46 (notification);
(c)any request for information which it has received from a market surveillance authority regarding conformity assessment activities;
(d)on request, any conformity assessment activities performed within the scope of its notification under regulation 46 and any other activity performed, including cross-border activities and subcontracting.
Extent Information
E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
27. [F11An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—
(a)to refuse to issue a certificate of conformity or grant an approval;
(b)to restrict, suspend or withdraw a certificate of conformity or approval.
Extent Information
E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F11Words in Sch. 4 para. 27 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
27. A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—
(a)to refuse to issue a certificate of conformity or grant an approval;
(b)to restrict, suspend or withdraw a certificate of conformity or approval.
Extent Information
E22This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
28. [F12An approved] body must provide other bodies [F7approved] under these Regulations carrying out similar conformity assessment activities covering the same vessels with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Extent Information
E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F7Word in Sch. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(b) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Sch. 4 para. 28 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
28. A notified body must provide other bodies notified under these Regulations carrying out similar conformity assessment activities covering the same vessels with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Extent Information
E23This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
29. [F13An approved] body must participate in the work of any [F7approved] body coordination group established [F14by the Secretary of State], directly or by means of its designated representatives.
Extent Information
E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F7Word in Sch. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(b) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Sch. 4 para. 29 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F14Words in Sch. 4 para. 29 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 42(d) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
29. A notified body must participate in the work of any notified body coordination group established under the Directive, directly or by means of its designated representatives.
Extent Information
E24This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only