Regulation 50
SCHEDULE 6U.K.Operational obligations of [F1notified] [F1approved] bodies
Textual Amendments
F1Word in Sch. 6 heading 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. 20 para. 40(a) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
1. [F2An approved] body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.E+W+S
Extent Information
E1This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F2Words in Sch. 6 para. 1 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
1. A notified body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.N.I.
Extent Information
E12This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
2. [F3An approved] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for economic operators.E+W+S
Extent Information
E2This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F3Words in Sch. 6 para. 2 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
2. A notified body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for economic operators.N.I.
Extent Information
E13This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
3. Conformity assessment bodies must 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 apparatus technology in question and the mass or serial nature of the production process.U.K.
4. Conformity assessment bodies must respect the degree of rigour and level of protection required for the compliance of the apparatus with these Regulations.U.K.
5. Where [F4an approved] body finds that the essential requirements or the corresponding [F5designated] standards or other technical specifications have not been met by a manufacturer, it must require that manufacturer to take appropriate corrective measures and must not issue a certificate.E+W+S
Extent Information
E3This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F4Words in Sch. 6 para. 5 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F5Word in Sch. 6 para. 5 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. 20 para. 40(c) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
5. Where a notified body finds that the essential requirements or the corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it must require that manufacturer to take appropriate corrective measures and must not issue a certificate.N.I.
Extent Information
E14This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
6. Where, in the course of the monitoring of the conformity of apparatus following the issue of a certificate, [F6an approved] body finds that apparatus is no longer in conformity, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate if necessary.E+W+S
Extent Information
E4This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F6Words in Sch. 6 para. 6 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
6. Where, in the course of the monitoring of the conformity of apparatus following the issue of a certificate, a notified body finds that apparatus is no longer in conformity, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate if necessary.N.I.
Extent Information
E15This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
7. Where corrective measures are not taken or do not have the required corrective effect, the [F7approved] body must restrict, suspend or withdraw any certificate as appropriate.E+W+S
Extent Information
E5This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F7Word in Sch. 6 para. 7 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. 20 para. 40(a) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
7. Where corrective measures are not taken or do not have the required corrective effect, the notified body must restrict, suspend or withdraw any certificate as appropriate.N.I.
Extent Information
E16This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
8. Paragraph 9 applies where [F8an approved] body is minded to—E+W+S
(a)refuse to issue a certificate; or
(b)restrict, suspend or withdraw a certificate.
Extent Information
E6This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F8Words in Sch. 6 para. 8 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
8. Paragraph 9 applies where a notified body is minded to—N.I.
(a)refuse to issue a certificate; or
(b)restrict, suspend or withdraw a certificate.
Extent Information
E17This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
9. Where this paragraph applies, the [F9approved] body must—E+W+S
(a)give the person applying for the certificate, or the person to whom the certificate was 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 applying for the certificate, or the person to whom the certificate was given, an opportunity to make representations within a reasonable period from the date of the notice; and
(c)take account of any such representations before taking its decision.
Extent Information
E7This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F9Word in Sch. 6 para. 9 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. 20 para. 40(a) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
9. Where this paragraph applies, the notified body must—N.I.
(a)give the person applying for the certificate, or the person to whom the certificate was 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 applying for the certificate, or the person to whom the certificate was given, an opportunity to make representations within a reasonable period from the date of the notice; and
(c)take account of any such representations before taking its decision.
Extent Information
E18This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
10. [F10An approved] body must inform the Secretary of State of—E+W+S
(a)any refusal, restriction, suspension or withdrawal of a certificate;
(b)any circumstances affecting the scope of, or conditions for, notification under regulation 44 (notification);
(c)any request for information which it has received from the market surveillance authority regarding conformity assessment activities; and
(d)on request, conformity assessment activities performed within the scope of its notifications under regulation 44 and any other activity performed, including cross-border activities and subcontracting.
Extent Information
E8This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F10Words in Sch. 6 para. 10 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
10. A notified body must inform the Secretary of State of—N.I.
(a)any refusal, restriction, suspension or withdrawal of a certificate;
(b)any circumstances affecting the scope of, or conditions for, notification under regulation 44 (notification);
(c)any request for information which it has received from the market surveillance authority regarding conformity assessment activities; and
(d)on request, conformity assessment activities performed within the scope of its notifications under regulation 44 and any other activity performed, including cross-border activities and subcontracting.
Extent Information
E19This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
11. [F11An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—E+W+S
(a)to refuse to issue a certificate; or
(b)to restrict, suspend or withdraw a certificate.
Extent Information
E9This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F11Words in Sch. 6 para. 11 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
11. A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—N.I.
(a)to refuse to issue a certificate; or
(b)to restrict, suspend or withdraw a certificate.
Extent Information
E20This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
12. [F12An approved] body must provide other bodies [F13approved under these Regulations] carrying out similar conformity assessment activities covering the same type of apparatus with relevant information on issues relating to negative and, on request, positive conformity assessment results.E+W+S
Extent Information
E10This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F12Words in Sch. 6 para. 12 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Sch. 6 para. 12 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. 20 para. 40(d) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
12. A notified body must provide other bodies notified under the Directive carrying out similar conformity assessment activities covering the same type of apparatus with relevant information on issues relating to negative and, on request, positive conformity assessment results.N.I.
Extent Information
E21This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
13. [F14An approved] body must participate in the work of [F15any approved] body coordination group established [F16by the Secretary of State], directly or by means of its designated representatives.E+W+S
Extent Information
E11This version of this provision extends to England, Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F14Words in Sch. 6 para. 13 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. 20 para. 40(b) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F15Words in Sch. 6 para. 13 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. 20 para. 40(e)(ii) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F16Words in Sch. 6 para. 13 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. 20 para. 40(e)(i) (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
13. 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.N.I.
Extent Information
E22This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only