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Regulation 39(2)
Textual Amendments
F1Word in Sch. 4 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. 27 para. 51(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
1. Conformity assessment must be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.U.K.
2. Conformity assessment bodies must perform their activities taking due account of—U.K.
(a)the size of an undertaking;
(b)the sector in which it operates,
(c)its structure;
(d)the degree of complexity of the of the measuring instrument technology in question; and
(e)the mass or serial nature of the production process,
but respecting the degree of rigour and the level of protection required for compliance of the measuring instrument with these Regulations.
3. Where [F2an approved] body finds that the essential requirements have not been met by a manufacturer—E+W+S
(a)it must require that manufacturer to take appropriate corrective measures; and
(b)it must not issue a certificate of conformity.
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
F2Words in Sch. 4 para. 3 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. 27 para. 51(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
3. Where a notified body finds that the essential requirements have not been met by a manufacturer—N.I.
(a)it must require that manufacturer to take appropriate corrective measures; and
(b)it must not issue a certificate of conformity.
Extent Information
E7This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
4. Where in the course of the monitoring of conformity following the issue of a certificate, [F3an approved] body finds that a measuring instrument no longer complies, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate if necessary.E+W+S
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
F3Words in Sch. 4 para. 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. 27 para. 51(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
4. Where in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a measuring instrument no longer complies, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate if necessary.N.I.
Extent Information
E8This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
5. Where corrective measures are not taken or do not have the required effect, the [F4approved] body must restrict, suspend or withdraw any certificates, as appropriate.E+W+S
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
F4Word 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. 27 para. 51(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
5. Where corrective measures are not taken or do not have the required effect, the notified body must restrict, suspend or withdraw any certificates, as appropriate.N.I.
Extent Information
E9This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
6. Where a person is aggrieved at a decision taken by [F5an approved] body in relation to the conformity assessment of a measuring instrument, the [F4approved] body must have appropriate arrangements for the review of that decision by a person who was not involved in the taking of that decision.E+W+S
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
F4Word 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. 27 para. 51(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Sch. 4 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. 27 para. 51(a) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
6. Where a person is aggrieved at a decision taken by a notified body in relation to the conformity assessment of a measuring instrument, the notified body must have appropriate arrangements for the review of that decision by a person who was not involved in the taking of that decision.N.I.
Extent Information
E10This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
7. [F4Approved] bodies must inform the [F6Secretary of State] of the following—E+W+S
(a)any refusal, restriction, suspension or withdrawal of a certificate;
(b)any circumstances affecting the scope of or conditions for [F7approval];
(c)any request for information which they have received from market surveillance authorities regarding conformity assessment; and
(d)on request, conformity assessment activities performed within the scope of their [F8approval] and any other activity performed, including cross-border activities and subcontracting.
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
F4Word 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. 27 para. 51(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Sch. 4 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. 27 para. 51(c)(i) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F7Word in Sch. 4 para. 7(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. 27 para. 51(c)(ii) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F8Word in Sch. 4 para. 7(d) 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. 27 para. 51(c)(ii) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
7. Notified bodies must inform the notifying authority of the following—N.I.
(a)any refusal, restriction, suspension or withdrawal of a certificate;
(b)any circumstances affecting the scope of or conditions for notification;
(c)any request for information which they have received from market surveillance authorities regarding conformity assessment; and
(d)on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Extent Information
E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
8. [F4Approved] bodies must provide other bodies [F9approved] [F4approved] under [F10these Regulations] carrying out similar conformity assessment activities covering the same measuring instruments with relevant information on issues relating to negative and, on request positive conformity assessment results.E+W+S
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
F4Word 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. 27 para. 51(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F9Word in Sch. 4 para. 8 inserted (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. 27 para. 51(d)(i) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Sch. 4 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. 27 para. 51(d)(ii) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
8. Notified bodies must provide other bodies notified under this Directive carrying out similar conformity assessment activities covering the same measuring instruments with relevant information on issues relating to negative and, on request positive conformity assessment results.N.I.
Extent Information
E12This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
9. [F4Approved] bodies must—E+W+S
(a)when requested by the Secretary of State, nominate a representative to attend a group F11...; and
(b)ensure attendance of that representative at meetings of the group.
Textual Amendments
F4Word 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. 27 para. 51(b) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F11Words in Sch. 4 para. 9 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. 27 para. 51(e) (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
9. Notified bodies must—N.I.
(a)when requested by the Secretary of State, nominate a representative to attend a group convened by the Commission pursuant to Article 40 of the Directive; and
(b)ensure attendance of that representative at meetings of the group.
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