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) (c. 425)

ANNEX VI U.K.

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (Module C) U.K.

1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares under his sole responsibility that the PPE concerned is in conformity with the type described in the F1 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F1 Word in Annex 6 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(49)(a); 2020 c. 1, Sch. 5 para. 1(1)

2. Manufacturing U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure 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

F2 Word in Annex 6 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(49)(a); 2020 c. 1, Sch. 5 para. 1(1)

3. [F3 UK] marking and F4 ... declaration of conformity U.K.

3.1. The manufacturer shall affix the [F5 UK] marking to each individual PPE that is in conformity with the type described in the F6 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F5 Word in Annex 6 para. 3.1 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(49)(c); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Annex 6 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(49)(b); 2020 c. 1, Sch. 5 para. 1(1)

3.2. The manufacturer shall draw up a written F6 ... declaration of conformity for a PPE model and keep it at the disposal of the national authorities for 10 years after the PPE has been placed on the market. The F6 ... declaration of conformity shall identify the PPE for which it has been drawn up. U.K.

A copy of the F6 ... declaration of conformity shall be made available to the relevant authorities upon request.

Textual Amendments

F3 Word in Annex 6 para. 3 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(49)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Annex 6 para. 3 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(49)(a); 2020 c. 1, Sch. 5 para. 1(1)

4. Authorised representative U.K.

The manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.