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 V U.K.

F1 ... TYPE-EXAMINATION (Module B) U.K.

7. Review of the F2 ... type-examination certificate U.K.

7.1. The [F3 approved] body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable essential health and safety requirements, and shall determine whether such changes require further investigation. If so, the [F3 approved] body shall inform the manufacturer accordingly. U.K.

Textual Amendments

F3 Word in Annex 5 para. 7.1 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(48)(f); 2020 c. 1, Sch. 5 para. 1(1)

7.2. The manufacturer shall inform the [F4 approved] body that holds the technical documentation relating to the F5 ... type-examination certificate of all modifications to the approved type and of all modifications of the technical documentation that may affect the conformity of the PPE with the applicable essential health and safety requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original F5 ... type-examination certificate. U.K.

Textual Amendments

F4 Word in Annex 5 para. 7.2 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(48)(e); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Annex 5 para. 7.2 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(48)(d); 2020 c. 1, Sch. 5 para. 1(1)

7.3. The manufacturer shall ensure that the PPE continues to fulfil the applicable essential health and safety requirements in light of the state of the art. U.K.

7.4. The manufacturer shall ask the [F6 approved] body to review the F7 ... type-examination certificate either: U.K.

(a)

in the case of a modification to the approved type referred to in point 7.2;

(b)

in the case of a change in the state of the art referred to in point 7.3;

(c)

at the latest, before the date of expiry of the certificate.

In order to allow the [F6 approved] body to fulfil its tasks, the manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the F7 ... type-examination certificate.

Textual Amendments

F6 Word in Annex 5 para. 7.4 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(48)(f); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Annex 5 para. 7.4 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(48)(d); 2020 c. 1, Sch. 5 para. 1(1)

7.5. The [F8 approved] body shall examine the PPE type and, where necessary in the light of the changes made, carry out the relevant tests to ensure that the approved type continues to fulfil the applicable essential health and safety requirements. If the [F8 approved] body is satisfied that the approved type continues to fulfil the applicable health and safety requirements, it shall renew the F9 ... type-examination certificate. The [F8 approved] body shall ensure that the review procedure is finalised before the expiry date of the F9 ... type-examination certificate. U.K.

Textual Amendments

F8 Word in Annex 5 para. 7.5 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(48)(f); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Annex 5 para. 7.5 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(48)(d); 2020 c. 1, Sch. 5 para. 1(1)

7.6. Where the conditions referred to in points (a) and (b) of point 7.4 are not met, a simplified review procedure shall apply. The manufacturer shall supply the [F10 approved] body with the following: U.K.

(a)

his name and address and data identifying the F11 ... type-examination certificate concerned;

(b)

confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant [F12 designated] standards or other technical specifications applied;

(c)

confirmation that there has been no change in the state of the art as referred to in point 7.3;

(d)

where not already supplied, copies of current product drawings and photographs, product marking and information supplied by the manufacturer; and

(e)

for category III products, where not already available to the [F10 approved] body, information on the results of the supervised product checks at random intervals carried out in accordance with Annex VII, or on the results of audits of his quality system carried out in accordance with Annex VIII.

Textual Amendments

F11 Word in Annex 5 para. 7.6 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(48)(d); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Annex 5 para. 7.6(b) 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(48)(j); 2020 c. 1, Sch. 5 para. 1(1)

Where the [F10 approved] body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out. In such cases, the [F10 approved] body shall renew the F11 ... type-examination certificate.

The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure.

If the [F10 approved] body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply.

Textual Amendments

F10 Word in Annex 5 para. 7.6 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(48)(f); 2020 c. 1, Sch. 5 para. 1(1)

7.7. If, following the review, the [F13 approved] body concludes that the F14 ... type-examination certificate is no longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the market of the PPE concerned. U.K.

Textual Amendments

F13 Word in Annex 5 para. 7.7 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(48)(e); 2020 c. 1, Sch. 5 para. 1(1)

F14 Word in Annex 5 para. 7.7 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(48)(c); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F2 Word in Annex 5 para. 7 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(48)(a); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F1 Word in Annex 5 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(48)(a); 2020 c. 1, Sch. 5 para. 1(1)