18. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 19 and 20 of this Schedule and ensures and declares that the apparatus concerned is in conformity with the type described in the [F1Type] Examination certificate and satisfies the requirements of these Regulations that apply to it.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
F1Word in Sch. 3 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. 20 para. 37(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)
18. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 19 and 20 of this Schedule and ensures and declares that the apparatus concerned is in conformity with the type described in the EU-type Examination certificate and satisfies the requirements of these Regulations that apply to it.N.I.
Extent Information
E4This version of this provision extends to Northern Ireland only; a separate version has been created for England, Wales and Scotland only
19. The manufacturer must take all measures necessary to ensure that the manufacturing process and the monitoring of that process ensure the conformity of the manufactured apparatus with the approved type described in the [F2Type] examination certificate and with the requirements of these Regulations that apply to it.
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
F2Word in Sch. 3 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. 20 para. 37(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)
19. The manufacturer must take all measures necessary to ensure that the manufacturing process and the monitoring of that process ensure the conformity of the manufactured apparatus with the approved type described in the EU-type examination certificate and with the requirements of these Regulations that apply to it.
20.—(1) The manufacturer must affix the [F5UK] marking to each individual apparatus that is in conformity with the type described on the [F6Type] examination certificate and satisfies the applicable requirements of these Regulations.
(2) The manufacturer must draw up a written F7... declaration of conformity for each apparatus model and keep it at the disposal of the national authorities for 10 years after the apparatus has been placed on the market. The F7... declaration of conformity must identify the apparatus model for which it has been drawn up.
(3) A copy of the F8... declaration of conformity must be made available to the relevant authorities upon request.
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
F3Word in Sch. 3 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. 20 para. 37(b)(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)
F4Word in Sch. 3 para. 20 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. 20 para. 37(b)(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)
F5Word in Sch. 3 para. 20(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. 37(c)(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)
F6Word in Sch. 3 para. 20(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. 37(c)(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)
F7Word in Sch. 3 para. 20(2) 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. 20 para. 37(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)
F8Word in Sch. 3 para. 20(3) 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. 20 para. 37(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)
20.—(1) The manufacturer must affix the CE marking to each individual apparatus that is in conformity with the type described on the EU-type examination certificate and satisfies the applicable requirements of these Regulations.
(2) The manufacturer must draw up a written EU declaration of conformity for each apparatus model and keep it at the disposal of the national authorities for 10 years after the apparatus has been placed on the market. The EU declaration of conformity must identify the apparatus model for which it has been drawn up.
(3) A copy of the EU declaration of conformity must be made available to the relevant authorities upon request.
21. The manufacturer's obligations set out in paragraph 20 of this Schedule may be fulfilled by an authorised representative on behalf of the manufacturer and under the responsibility of the manufacturer provided that these responsibilities are set out in the authorised representative's written mandate.