Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS (Module C2) U.K.

1. Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 5.2 and 6, and ensures and declares on his sole responsibility that the PPE, which has been subject to the provisions of point 4, 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 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)

2. Manufacturing U.K.

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

F2 Word 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)

3. Application for supervised product checks at random intervals U.K.

Before placing PPE on the market, the manufacturer shall lodge an application for supervised product checks at random intervals with a single [F3 approved] body of his choice.

Textual Amendments

F3 Word 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:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address;

(b)

a written declaration that the same application has not been lodged with any other [F3 approved] body;

(c)

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

F4 Word 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)

(a)

the technical documentation described in Annex III;

(b)

a copy of the F4 ... type-examination certificate.

4. Product checks U.K.

4.1. The [F5 approved] body shall carry out product checks in order to verify the homogeneity of production and the conformity of the PPE with the type described in the F6 ... type-examination certificate and with the applicable essential health and safety requirements. U.K.

Textual Amendments

F5 Word 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)

F6 Word 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)

4.2. The product checks shall be carried out at least once a year, at random intervals determined by the [F7 approved] body. The first product checks shall be carried out no more than one year after the date of issue of the F8 ... type-examination certificate. U.K.

Textual Amendments

F7 Word 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)

F8 Word 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)

4.3. An adequate statistical sample of the manufactured PPE shall be selected by the [F9 approved] body at a place agreed between the body and the manufacturer. All items of PPE of the sample shall be examined, and appropriate tests set out in the relevant [F10 designated] standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify the conformity of the PPE with the type described in the F11 ... type-examination certificate and with the applicable essential health and safety requirements. U.K.

Textual Amendments

F9 Word 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)

F10 Word 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)

F11 Word 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)

4.4. Where the [F12 approved] body referred to in point 3 is not the body that issued the relevant F13 ... type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample. U.K.

Textual Amendments

F12 Word 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)

F13 Word 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)

4.5. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production and performs within acceptable limits, with a view to ensuring conformity of the PPE. U.K.

4.6. If the examination and testing reveal that the production is not homogeneous, or that the PPE does not comply with the type described in the F14 ... type-examination certificate or with the applicable essential health and safety requirements, the [F15 approved] body shall take measures appropriate to the fault(s) recorded and inform the [F16 Secretary of State] thereof. U.K.

Textual Amendments

F14 Word 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)

F15 Word 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)

F16 Words 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)

5. Test report U.K.

5.1. The [F17 approved] body shall provide the manufacturer with a test report. U.K.

Textual Amendments

F17 Word 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)

5.2. The manufacturer shall keep the test report at the disposal of the national authorities for 10 years after the PPE has been placed on the market. U.K.

5.3. The manufacturer shall, under the responsibility of the [F18 approved] body, affix the [F18 approved] body's identification number during the manufacturing process. U.K.

Textual Amendments

F18 Word 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)

6. [F19 UK] marking and F20 ... declaration of conformity U.K.

6.1. The manufacturer shall affix the [F21 UK] marking and, under the responsibility of the [F22 approved] body referred to in point 3, the latter's identification number to each individual item of PPE that is in conformity with the type described in the F23 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F21 Word 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)

F22 Word 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)

F23 Word 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)

6.2. The manufacturer shall draw up a written F24 ... declaration of conformity for each 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 F24 ... declaration of conformity shall identify the PPE model for which it has been drawn up. U.K.

A copy of the F24 ... declaration of conformity shall be made available to the relevant authorities upon request.

Textual Amendments

F24 Word 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

F19 Word 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)

F20 Word 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)

7. Authorised representative U.K.

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.