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Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
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Textual Amendments
F1Word in Annex 7 para. 1 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of production and conformity of the manufactured PPE with the type described in the F2... type-examination certificate and with the applicable requirements of this Regulation.
Textual Amendments
F2Word in Annex 7 para. 2 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
Before placing PPE on the market, the manufacturer shall lodge an application for supervised product checks at random intervals with a single [F3approved] body of his choice.
Textual Amendments
F3Word in Annex 7 para. 3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
The application shall include the following:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address;
a written declaration that the same application has not been lodged with any other [F3approved] body;
the identification of the PPE concerned.
Where the chosen body is not the body that has carried out the F4... type-examination, the application shall also include the following:
Textual Amendments
F4Word in Annex 7 para. 3 omitted (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. 35 para. 3(50)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
the technical documentation described in Annex III;
a copy of the F4... type-examination certificate.
Textual Amendments
F5Word in Annex 7 para. 4.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
F6Word in Annex 7 para. 4.1 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F7Word in Annex 7 para. 4.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
F8Word in Annex 7 para. 4.2 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F9Word in Annex 7 para. 4.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
F10Word in Annex 7 para. 4.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(d); 2020 c. 1, Sch. 5 para. 1(1)
F11Word in Annex 7 para. 4.3 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F12Word in Annex 7 para. 4.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
F13Word in Annex 7 para. 4.4 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F14Word in Annex 7 para. 4.6 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
F15Word in Annex 7 para. 4.6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
F16Words in Annex 7 para. 4.6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(e); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F17Word in Annex 7 para. 5.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F18Word in Annex 7 para. 5.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(f); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F21Word in Annex 7 para. 6.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(g); 2020 c. 1, Sch. 5 para. 1(1)
F22Word in Annex 7 para. 6.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(c); 2020 c. 1, Sch. 5 para. 1(1)
F23Word in Annex 7 para. 6.1 omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
A copy of the F24... declaration of conformity shall be made available to the relevant authorities upon request.
Textual Amendments
F24Word in Annex 7 para. 6.2 omitted (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. 35 para. 3(50)(h); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F19Word in Annex 7 para. 6 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(50)(g); 2020 c. 1, Sch. 5 para. 1(1)
F20Word in Annex 7 para. 6 heading omitted (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. 35 para. 3(50)(a); 2020 c. 1, Sch. 5 para. 1(1)
The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in point 2.
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