Regulation (EU) 2016/425 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER VI U.K. [F1 MARKET SURVEILLANCE AND CONTROL OF PPE ENTERING THE UNITED KINGDOM MARKET]

Article 37 U.K. [F2 Market surveillance and control of PPE entering the United Kingdom market]

[F3 Articles 15(3), 16 to 22 and 26 to 29] of Regulation (EC) No 765/2008 shall apply to PPE covered by Article 2(1) of this Regulation.

Textual Amendments

F2 Art. 37 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(35)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 37 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(35)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 38 U.K. Procedure F4 ... for dealing with PPE presenting a risk

1. Where the market surveillance [F5 authority has] sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons, [F6 the authority] shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance [F7 authority] for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance [F8 authority finds] that the PPE does not comply with the requirements laid down in this Regulation, [F9 the authority] shall without delay require the relevant economic operator to take all appropriate corrective action to bring the PPE into compliance with those requirements, to withdraw the PPE from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as [F9 the authority] may prescribe.

The market surveillance [F10 authority] shall inform the relevant [F11 approved] body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

F12 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE concerned that it has made available on the market F13 ....

4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance [F14 authority] shall take all appropriate F15 ... measures to prohibit or restrict the PPE being made available on [F16 the market], to withdraw the PPE from that market or to recall it.

F17 ...

F18 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F4 Words in Art. 38 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(36)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 38(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(36)(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 38(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(36)(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Art. 38(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(36)(b)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 38(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(36)(b)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 38(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(36)(b)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in Art. 38(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(36)(b)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Art. 38(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(36)(b)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F12 Art. 38(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(36)(c); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 38(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(36)(d); 2020 c. 1, Sch. 5 para. 1(1)

F14 Word in Art. 38(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(36)(e)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F15 Word in Art. 38(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(36)(e)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 38(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(36)(e)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Art. 38(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(36)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F18 Art. 38(5)-(8) 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(36)(f); 2020 c. 1, Sch. 5 para. 1(1)

F19 Article 39 U.K. Union safeguard procedure

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Textual Amendments

F19 Art. 39 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(37); 2020 c. 1, Sch. 5 para. 1(1)

Article 40 U.K. Compliant PPE which presents a risk

1. Where, having carried out an evaluation under Article 38(1), [F20 the enforcement authority] finds that although PPE is in compliance with this Regulation, it presents a risk to the health or safety of persons, it shall require the relevant economic operator to take all appropriate measures to ensure that the PPE concerned, when placed on the market, no longer presents that risk, to withdraw the PPE from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

2. The economic operator shall ensure that corrective action is taken in respect of all the PPE concerned that he has made available on the market F21 ....

F22 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Words in Art. 40(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(38)(a); 2020 c. 1, Sch. 5 para. 1(1)

F21 Words in Art. 40(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(38)(b); 2020 c. 1, Sch. 5 para. 1(1)

F22 Art. 40(3)-(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(38)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 41 U.K. Formal non-compliance

1. Without prejudice to Article 38, where [F23 the enforcement authority] makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the [F24 UK] marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 17 of this Regulation;

(b) the [F25 UK] marking has not been affixed;

(c) the identification number of the [F26 approved] body involved in the production control phase has been affixed in violation of Article 17 or has not been affixed;

(d) the F27 ... declaration of conformity has not been drawn up or has not been drawn up correctly;

(e) the technical documentation is either not available or not complete;

(f) the information referred to in Article 8(6) or Article 10(3) is absent, false or incomplete;

(g) any other administrative requirement provided for in Article 8 or Article 10 is not fulfilled.

2. Where the non-compliance referred to in paragraph 1 persists, the [F28 enforcement authority] shall take all appropriate measures to restrict or prohibit the PPE being made available on the market or ensure that it is recalled or withdrawn from the market.

Textual Amendments

F23 Words in Art. 41(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(39)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F24 Word in Art. 41(1)(a) 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(39)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F25 Word in Art. 41(1)(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(39)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F26 Word in Art. 41(1)(c) 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(39)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F27 Word in Art. 41(1)(d) 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(39)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F28 Words in Art. 41(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(39)(b); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F1 Ch. 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(34); 2020 c. 1, Sch. 5 para. 1(1)