The Radio Equipment Regulations 2017

Regulation 53

SCHEDULE 9 U.K. Operational obligations of [F1 notified] [F1 approved] bodies

Textual Amendments

F1 Word in Sch. 9 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. 29 para. 54(a)(i) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

1.   [F2 An approved] body must carry out conformity assessments in accordance with the relevant conformity assessment procedures in Schedule 3 (conformity assessment concerning EU-type examination) or Schedule 4 (conformity assessment concerning quality system approval).

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F2 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (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 in Schedule 3 (conformity assessment concerning EU-type examination) or Schedule 4 (conformity assessment concerning quality system approval). N.I.

Extent Information

E13 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

2.   [F3 An approved] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F3 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (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 on economic operators. N.I.

Extent Information

E14 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

3.  A conformity assessment 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 radio equipment technology in question and the mass or serial nature of the production process. U.K.

4.  A conformity assessment body must respect the degree of rigour and the level of protection required to ensure that the radio equipment is in conformity with the requirements of these Regulations. U.K.

5.  Where [F4 an approved] body finds that the essential requirements or the corresponding [F5 designated] standards have not been met by the manufacturer, that body must require that manufacturer to take appropriate corrective measures and must not issue [F6 a Type] examination certificate or quality system approval until the appropriate corrective measures have been taken. E+W+S

Extent Information

E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F4 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Sch. 9 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. 29 para. 54(e) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Sch. 9 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. 29 para. 54(c) (with Sch. 29 para. 44) (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 have not been met by the manufacturer, that body must require that manufacturer to take appropriate corrective measures and must not issue an EU-type examination certificate or quality system approval until the appropriate corrective measures have been taken. N.I.

Extent Information

E15 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.  Where, in the course of the monitoring of conformity following the issue of [F7 a Type] examination certificate or a quality system approval, [F8 an approved] body finds that the radio equipment is no longer in conformity with the essential requirements, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the [F9 Type] examination certificate or quality system approval (if necessary). E+W+S

Extent Information

E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F7 Words in Sch. 9 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. 29 para. 54(c) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Sch. 9 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. 29 para. 54(d) (with Sch. 29 para. 44) (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 conformity following the issue of an EU-type examination certificate or a quality system approval, a notified body finds that the radio equipment is no longer in conformity with the essential requirements, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the EU-type examination certificate or quality system approval (if necessary). N.I.

Extent Information

E16 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

7.  Where the [F10 approved] 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 [F10 approved] body must restrict, suspend or withdraw any [F11 Type] examination certificates or quality system approvals as appropriate. E+W+S

Extent Information

E5 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F10 Word in Sch. 9 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. 29 para. 54(a)(ii) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Sch. 9 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. 29 para. 54(d) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

7.  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 EU-type examination certificates or quality system approvals as appropriate. N.I.

Extent Information

E17 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

8.  Paragraph 9 applies where [F12 an approved] body is minded to— E+W+S

(a) refuse to issue [F13 a Type] examination certificate,

(b) refuse to grant a quality system approval, or

(c) restrict, suspend or withdraw [F13 a Type] examination certificate or quality system approval.

Extent Information

E6 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F12 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Sch. 9 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. 29 para. 54(c) (with Sch. 29 para. 44) (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 an EU-type examination certificate,

(b) refuse to grant a quality system approval, or

(c) restrict, suspend or withdraw an EU-type examination certificate or quality system approval.

Extent Information

E18 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

9.  Where this paragraph applies, the [F14 approved] body must— E+W+S

(a) give the person applying for the [F15 Type] examination certificate or quality system approval, or the person to whom the [F15 Type] examination certificate or quality system approval was given—

(i) a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect, and

(ii) an opportunity to make representations within a reasonable period from the date of the notice, and

(b) take account of any representations made under sub-paragraph (a)(ii) before taking its decision.

Extent Information

E7 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F14 Word in Sch. 9 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. 29 para. 54(a)(ii) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F15 Word in Sch. 9 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. 29 para. 54(d) (with Sch. 29 para. 44) (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 EU-type examination certificate or quality system approval, or the person to whom the EU-type examination certificate or quality system approval was given—

(i) a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect, and

(ii) an opportunity to make representations within a reasonable period from the date of the notice, and

(b) take account of any representations made under sub-paragraph (a)(ii) before taking its decision.

Extent Information

E19 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

10.   [F16 An approved] body must inform the Secretary of State of—

(a) any refusal, restriction, suspension or withdrawal of [F17 a Type] examination certificate or quality system approval in accordance with the requirements of Schedule 3 or Schedule 4 as appropriate,

(b) any circumstances affecting the scope of, or conditions for, [F18 approval] under regulation 47 ([F19 approval of conformity assessment bodies]),

(c) any request for information which it has received from an enforcing authority F20 ... regarding conformity assessment activities, and

(d) on request, conformity assessment activities performed within the scope of its notification under regulation 47 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E8 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F16 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Sch. 9 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. 29 para. 54(c) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in Sch. 9 para. 10(b) 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. 29 para. 54(f)(i) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Sch. 9 para. 10(b) 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. 29 para. 54(f)(ii) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F20 Words in Sch. 9 para. 10(c) 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. 29 para. 54(g) (with Sch. 29 para. 44) (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 an EU-type examination certificate or quality system approval in accordance with the requirements of Schedule 3 or Schedule 4 as appropriate,

(b) any circumstances affecting the scope of, or conditions for, notification under regulation 47 (notification),

(c) any request for information which it has received from an enforcing authority or a competent national authority of another [F30 relevant state] regarding conformity assessment activities, and

(d) on request, conformity assessment activities performed within the scope of its notification under regulation 47 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E20 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F30 Words in Sch. 9 para. 10(c) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 16 para. 8(3)

11.   [F21 An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—

(a) to refuse to issue [F22 a Type] examination certificate or quality system approval decision, or

(b) to restrict, suspend or withdraw [F22 a Type] examination certificate or quality system approval decision.

Extent Information

E9 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F21 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Sch. 9 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. 29 para. 54(c) (with Sch. 29 para. 44) (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 an EU-type examination certificate or quality system approval decision, or

(b) to restrict, suspend or withdraw an EU-type examination certificate or quality system approval decision.

Extent Information

E21 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

12.   [F23 An approved] body must, in accordance with the requirements in Schedule 3 and Schedule 4, provide other bodies [F24 approved] under [F25 these Regulations] carrying out similar conformity assessment activities covering the same type of radio equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Extent Information

E10 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F23 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F24 Word in Sch. 9 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. 29 para. 54(a)(iii) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Sch. 9 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. 29 para. 54(h) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

12.  A notified body must, in accordance with the requirements in Schedule 3 and Schedule 4, provide other bodies notified under the Directive carrying out similar conformity assessment activities covering the same type of radio equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results. N.I.

Extent Information

E22 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

13.   [F26 An approved] body must participate in the work of any [F27 approved] body coordination group established [F28 by the Secretary of State], directly or by means of its designated representatives.

Extent Information

E11 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F26 Words in Sch. 9 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F27 Word in Sch. 9 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. 29 para. 54(a)(iii) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F28 Words in Sch. 9 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. 29 para. 54(i) (with Sch. 29 para. 44) (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

E23 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

14.   [F29 An approved] body must fulfil any information obligations under Schedules 3 and 4.

Extent Information

E12 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F29 Words in Sch. 9 para. 14 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. 29 para. 54(b) (with Sch. 29 para. 44) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

14.  A notified body must fulfil any information obligations under Schedules 3 and 4. N.I.

Extent Information

E24 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only