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The Pressure Equipment (Safety) Regulations 2016

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PART 2U.K.Obligations of economic operators

ManufacturersU.K.

Design and manufacture in accordance with essential safety requirementsU.K.

9.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements.

(2) Before placing pressure equipment or an assembly referred to in regulation 8 on the market or using it for their own purposes, a manufacturer must ensure that it complies with regulation 8(2).

Technical documentation and conformity assessmentE+W+S

10.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must—

(a)classify it using the categories set out in Schedule 3 (classification of pressure equipment), according to an ascending level of hazard;

(b)determine the conformity assessment procedures to apply to the pressure equipment or assembly in accordance with regulation 41 (conformity assessment procedure);

(c)carry out the relevant conformity assessment procedure in respect of that pressure equipment or assembly, or have such a procedure carried out; and

(d)draw up the relevant technical documentation referred to in the conformity assessment module followed in accordance with regulation 41.

(2) For the purposes of paragraph (1)(d), the relevant technical documentation is the following with reference to the modules set out in [F1Schedule 1A to these Regulations]

(a)where Module A is followed, the technical documentation is the technical documentation referred to in point 2 under Module A (Internal production control);

(b)where Module A2 is followed, the technical documentation is the technical documentation referred to in point 2 under Module A2 (Internal production control plus supervised pressure equipment checks at random intervals);

(c)where Module B (production type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B ([F2Type] examination – production type);

(d)where Module B (design type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B ([F2Type] examination – design type);

(e)where Module G is followed, the technical documentation is the technical documentation referred to in point 2 under Module G (Conformity based on unit verification);

(f)where Module H is followed, the technical documentation is the technical documentation referred to in point 3 under Module H (Conformity based on full quality assurance);

(g)where Module H1 is followed, the technical documentation is the technical documentation referred to in point 3 under Module H1 (Conformity based on full quality assurance plus design examination).

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Technical documentation and conformity assessmentN.I.

10.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must—

(a)classify it using the categories set out in Schedule 3 (classification of pressure equipment), according to an ascending level of hazard;

(b)determine the conformity assessment procedures to apply to the pressure equipment or assembly in accordance with regulation 41 (conformity assessment procedure);

(c)carry out the relevant conformity assessment procedure in respect of that pressure equipment or assembly, or have such a procedure carried out; and

(d)draw up the relevant technical documentation referred to in the conformity assessment module followed in accordance with regulation 41.

(2) For the purposes of paragraph (1)(d), the relevant technical documentation is the following with reference to the modules set out in Annex III to the Directive (as amended from time to time)—

(a)where Module A is followed, the technical documentation is the technical documentation referred to in point 2 under Module A (Internal production control);

(b)where Module A2 is followed, the technical documentation is the technical documentation referred to in point 2 under Module A2 (Internal production control plus supervised pressure equipment checks at random intervals);

(c)where Module B (production type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B (EU-type examination – production type);

(d)where Module B (design type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B (EU-type examination – design type);

(e)where Module G is followed, the technical documentation is the technical documentation referred to in point 2 under Module G (Conformity based on unit verification);

(f)where Module H is followed, the technical documentation is the technical documentation referred to in point 3 under Module H (Conformity based on full quality assurance);

(g)where Module H1 is followed, the technical documentation is the technical documentation referred to in point 3 under Module H1 (Conformity based on full quality assurance plus design examination).

Extent Information

E20This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F3Declaration] of conformity and [F4UK] markingE+W+S

11.—(1) Where the conformity of pressure equipment or an assembly referred to in regulation 6 or 7 with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the pressure equipment or assembly on the market—

(a)draw up a declaration of conformity in accordance with regulation 48 (F5... declaration of conformity);

(b)affix the [F6UK] marking in accordance with regulation 49 (CE marking); and

(c)where applicable, ensure that the identification number of the [F7approved] body is affixed in accordance with regulation 49.

(2) The requirement in paragraph (1)(b) does not apply in cases where—

(a)the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b)the conformity assessment procedure has been carried out by a user inspectorate.

(3) The manufacturer must keep the F8... declaration of conformity up-to-date.

[F9(4) Where pressure equipment or an assembly is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.]

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU declaration of conformity and CE markingN.I.

11.—(1) Where the conformity of pressure equipment or an assembly referred to in regulation 6 or 7 with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the pressure equipment or assembly on the market—

(a)draw up a declaration of conformity in accordance with regulation 48 (EU declaration of conformity);

(b)affix the CE marking in accordance with regulation 49 (CE marking); and

(c)where applicable, ensure that the identification number of the notified body is affixed in accordance with regulation 49.

(2) The requirement in paragraph (1)(b) does not apply in cases where—

(a)the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b)the conformity assessment procedure has been carried out by a user inspectorate.

(3) The manufacturer must keep the EU declaration of conformity up-to-date.

(4) Where pressure equipment or an assembly is subject to more than one EU instrument requiring a declaration of conformity to be drawn up, the manufacturer must draw up a single declaration of conformity which—

(a)identifies the EU instruments; and

(b)includes references to the publication of those EU instruments in the Official Journal.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Duty to keep technical documentation and F10... declaration of conformityE+W+S

12.  A manufacturer must keep the technical documentation and the F11... declaration of conformity drawn up in respect of pressure equipment or an assembly and make them available for inspection by the enforcing authorities for a period of 10 years beginning on the day on which the pressure equipment or assembly is placed on the market.

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to keep technical documentation and EU declaration of conformityN.I.

12.  A manufacturer must keep the technical documentation and the EU declaration of conformity drawn up in respect of pressure equipment or an assembly and make them available for inspection by the enforcing authorities for a period of 10 years beginning on the day on which the pressure equipment or assembly is placed on the market.

Extent Information

E22This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Labelling of pressure equipment and assembliesE+W+S

13.—(1) Before placing pressure equipment or an assembly on the market, a manufacturer must—

(a)ensure that it bears a type, batch or serial number or other element allowing its identification; and

(b)ensure that it is marked with—

(i)the name, registered trade name or registered trade mark of the manufacturer; and

(ii)a single postal address at which the manufacturer can be contacted.

(2) Where it is not possible for information specified in paragraph (1)(a) and (b) to be indicated on the pressure equipment or assembly, the manufacturer must ensure that the information is indicated on its packaging or in a document accompanying the pressure equipment or assembly.

[F12(3) The details set out in paragraph (1)(b) must be clear, legible and in easily understandable English.]

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Labelling of pressure equipment and assembliesN.I.

13.—(1) Before placing pressure equipment or an assembly on the market, a manufacturer must—

(a)ensure that it bears a type, batch or serial number or other element allowing its identification; and

(b)ensure that it is marked with—

(i)the name, registered trade name or registered trade mark of the manufacturer; and

(ii)a single postal address at which the manufacturer can be contacted.

(2) Where it is not possible for information specified in paragraph (1)(a) and (b) to be indicated on the pressure equipment or assembly, the manufacturer must ensure that the information is indicated on its packaging or in a document accompanying the pressure equipment or assembly.

(3) The details set out in paragraph (1)(b) must be in a language which can be easily understood by consumers, other users and market surveillance authorities in the [F46relevant state] in which it is to be made available to such users.

Extent Information

E23This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Instructions and safety informationE+W+S

14.—(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, a manufacturer must ensure that it is accompanied by instructions and safety information [F13that are clear, legible and in easily understandable English].

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, a manufacturer must ensure that it is accompanied by adequate instructions for use [F14that are clear, legible and in easily understandable English].

F15(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Instructions and safety informationN.I.

14.—(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other users.

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, a manufacturer must ensure that it is accompanied by adequate instructions for use in a language which can be easily understood by consumers and other users.

(4) Where the pressure equipment or assembly is placed on the market in [F47Northern Ireland], the language referred to in paragraphs (1) and (3) must be English.

(5) Instructions and safety information must be clear, understandable and intelligible.

Extent Information

E24This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Compliance procedures for series productionE+W+S

15.—(1) A manufacturer of pressure equipment or assemblies which are manufactured by series production must ensure that procedures are in place to ensure that any pressure equipment or assemblies so manufactured will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any change in pressure equipment or assembly design or characteristics; and

(b)any change in a [F16designated] standard or in another technical specification by reference to which the F17... declaration of conformity was drawn up.

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Compliance procedures for series productionN.I.

15.—(1) A manufacturer of pressure equipment or assemblies which are manufactured by series production must ensure that procedures are in place to ensure that any pressure equipment or assemblies so manufactured will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any change in pressure equipment or assembly design or characteristics; and

(b)any change in a harmonised standard or in another technical specification by reference to which the EU declaration of conformity was drawn up.

Extent Information

E25This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

MonitoringU.K.

16.—(1) When appropriate, with regard to the risks to the health and safety of consumers and other users presented by pressure equipment or assemblies, the manufacturer must—

(a)carry out sample testing of pressure equipment or assemblies made available on the market;

(b)investigate complaints that pressure equipment or assemblies are not in conformity with Part 2;

(c)keep a register of—

(i)complaints that pressure equipment or assemblies are not in conformity with Part 2;

(ii)pressure equipment or assemblies which are found not to be in conformity with Part 2; and

(iii)pressure equipment or assemblies recalls; and

(d)keep distributors informed of any monitoring carried out under this regulation.

(2) The manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

Duty to take action in respect of pressure equipment or assemblies placed on the market which are considered not to be in conformityE+W+S

17.—(1) A manufacturer who considers, or has reason to believe, that pressure equipment or an assembly which that manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring the pressure equipment or assembly into conformity;

(b)withdraw the pressure equipment or assembly; or

(c)recall the pressure equipment or assembly.

(2) Where pressure equipment or an assembly presents a risk, the manufacturer must immediately inform the market surveillance authorityF18... of the risk, giving details of—

(a)the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to take action in respect of pressure equipment or assemblies placed on the market which are considered not to be in conformityN.I.

17.—(1) A manufacturer who considers, or has reason to believe, that pressure equipment or an assembly which that manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring the pressure equipment or assembly into conformity;

(b)withdraw the pressure equipment or assembly; or

(c)recall the pressure equipment or assembly.

(2) Where pressure equipment or an assembly presents a risk, the manufacturer must immediately inform the market surveillance authority, and the competent national authorities of any other [F48relevant state] in which the manufacturer made the pressure equipment or assembly available on the market, of the risk, giving details of—

(a)the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E26This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Provision of information and cooperationU.K.

18.—(1) Further to a request from an enforcing authority, and within such period as the authority may specify, a manufacturer must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day the pressure equipment or assembly was placed on the market; and

(b)must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a)may be provided electronically; and

(b)must be in a language which can be easily understood by the enforcing authority.

(4) A manufacturer must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a)evaluate pressure equipment or an assembly in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b)eliminate the risks posed by pressure equipment or an assembly which the manufacturer has placed on the market.

Manufacturer's authorised representativesE+W+S

19.—(1) A manufacturer may, by written mandate, appoint a person as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to pressure equipment or assemblies covered by the mandate—

(a)perform the manufacturer's obligations under regulation 12 (duty to keep technical documentation and F19... declaration of conformity); and

(b)perform the manufacturer's obligations under regulation 18 (provision of information and cooperation).

(3) The obligations laid down in regulation 9 (design and manufacture in accordance with the essential safety requirements) and regulation 10(1)(b) (technical documentation and conformity assessment) must not form part of an authorised representative's mandate.

(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the manufacturer to perform and, accordingly as far as those duties, as well as the penalties for failure to comply with those duties, are concerned, references in these Regulations (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative.

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer's behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Manufacturer's authorised representativesN.I.

19.—(1) A manufacturer may, by written mandate, appoint a person as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to pressure equipment or assemblies covered by the mandate—

(a)perform the manufacturer's obligations under regulation 12 (duty to keep technical documentation and EU declaration of conformity); and

(b)perform the manufacturer's obligations under regulation 18 (provision of information and cooperation).

(3) The obligations laid down in regulation 9 (design and manufacture in accordance with the essential safety requirements) and regulation 10(1)(b) (technical documentation and conformity assessment) must not form part of an authorised representative's mandate.

(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the manufacturer to perform and, accordingly as far as those duties, as well as the penalties for failure to comply with those duties, are concerned, references in these Regulations (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative.

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer's behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.

Extent Information

E27This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

ImportersU.K.

Prohibition on placing on the market pressure equipment or assemblies which are not in conformityU.K.

20.  An importer must not place pressure equipment or an assembly on the market unless it is in conformity with Part 2.

Requirements which must be satisfied before an importer places pressure equipment or assemblies on the marketE+W+S

21.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, an importer must ensure that—

(a)the relevant conformity assessment procedure has been carried out;

(b)the manufacturer has drawn up the technical documentation;

(c)the pressure equipment or assembly—

(i)bears the [F20UK] marking; and

(ii)is accompanied by the required documents; and

(d)the manufacturer has complied with the requirements of regulation 13 (labelling).

(2) The requirement in paragraph (1)(c)(i) does not apply in cases where—

(a)the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b)the conformity assessment procedure has been carried out by a user inspectorate.

(3) Before placing pressure equipment or an assembly referred to in regulation 8 on the market, an importer must ensure that—

(a)the manufacturer has drawn up the technical documentation;

(b)the pressure equipment or assembly is accompanied by adequate instructions for use and any required documents; and

(c)the manufacturer has complied with the requirements of regulation 13 (labelling).

(4) In paragraphs (1)(c)(ii) and (3)(b), “required documents” means any documents that the manufacturer is required to provide with pressure equipment or an assembly pursuant to regulation 13(2) (labelling) and 14 (instructions and safety information).

Extent Information

E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Requirements which must be satisfied before an importer places pressure equipment or assemblies on the marketN.I.

21.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, an importer must ensure that—

(a)the relevant conformity assessment procedure has been carried out;

(b)the manufacturer has drawn up the technical documentation;

(c)the pressure equipment or assembly—

(i)bears the CE marking; and

(ii)is accompanied by the required documents; and

(d)the manufacturer has complied with the requirements of regulation 13 (labelling).

(2) The requirement in paragraph (1)(c)(i) does not apply in cases where—

(a)the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b)the conformity assessment procedure has been carried out by a user inspectorate.

(3) Before placing pressure equipment or an assembly referred to in regulation 8 on the market, an importer must ensure that—

(a)the manufacturer has drawn up the technical documentation;

(b)the pressure equipment or assembly is accompanied by adequate instructions for use and any required documents; and

(c)the manufacturer has complied with the requirements of regulation 13 (labelling).

(4) In paragraphs (1)(c)(ii) and (3)(b), “required documents” means any documents that the manufacturer is required to provide with pressure equipment or an assembly pursuant to regulation 13(2) (labelling) and 14 (instructions and safety information).

Extent Information

E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Prohibition on placing on the market pressure equipment or assemblies considered not to be in conformity with the essential safety requirementsU.K.

22.—(1) Where an importer considers, or has reason to believe, that pressure equipment or an assembly referred to in Regulation 6 or 7 is not in conformity with the essential safety requirements, the importer must not place the pressure equipment or assembly on the market.

(2) Where pressure equipment or an assembly presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Information identifying importerE+W+S

23.—(1) Before placing pressure equipment or an assembly on the market, an importer must indicate on the pressure equipment or assembly—

(a)the name, registered trade name or registered trade mark of the importer; and

(b)a postal address at which the importer can be contacted.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by consumers and other users and the market surveillance authority F21....

[F22(3) Paragraph (1) does not apply where—

(a)either—

(i)it is not possible to set out the information referred to in paragraph (1) on the pressure equipment or assembly, or

(ii)the importer has imported the pressure equipment or assembly from an EEA state or Switzerland and places it on the market within the period of [F23seven years] beginning with IP completion day, and

(b)before placing the pressure equipment or assembly on the market, the importer sets out the information referred to in paragraph (1) on the packaging of the pressure equipment or assembly or in a document accompanying the pressure equipment or assembly.]

Information identifying importerN.I.

23.—(1) Before placing pressure equipment or an assembly on the market, an importer must indicate on the pressure equipment or assembly—

(a)the name, registered trade name or registered trade mark of the importer; and

(b)a postal address at which the importer can be contacted.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by consumers and other users and the market surveillance authority in the [F49relevant state] in which it is to be made available to such users.

(3) Where it is not possible to indicate the information specified in paragraph (1) on [F50the pressure equipment or assembly], the importer must indicate that information—

(a)on the packaging; or

(b)in a document accompanying the pressure equipment or assembly.

Extent Information

E29This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Modifications etc. (not altering text)

Instructions and safety informationE+W+S

24.—(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, an importer must ensure that it is accompanied by instructions and safety information [F24that are clear, legible and in easily understandable English].

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, an importer must ensure that it is accompanied by instructions and safety information [F25that are clear, legible and in easily understandable English] .

F26(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Instructions and safety informationN.I.

24.—(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, an importer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other users.

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, an importer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other users.

(4) Where the pressure equipment or assembly is placed on the market in [F51Northern Ireland], the language referred to in paragraphs (1) and (3) must be English.

Extent Information

E30This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Storage and transportU.K.

25.  Where an importer has responsibility for pressure equipment or an assembly referred to in Regulation 6 or 7, the importer must ensure that the conditions under which the pressure equipment or assembly is stored or transported do not jeopardise its conformity with the essential safety requirements.

MonitoringU.K.

26.—(1) Where appropriate, having regard to the risks to the health and safety of consumers and other users presented by the pressure equipment or assemblies, the importer must—

(a)carry out sample testing of pressure equipment and assemblies made available on the market by the importer;

(b)investigate complaints of pressure equipment and assemblies made available on the market by the importer which are not in conformity with Part 2;

(c)keep a register of—

(i)complaints that pressure equipment or assemblies are not in conformity with Part 2;

(ii)pressure equipment or assemblies which are found not to be in conformity with Part 2; and

(iii)pressure equipment or assemblies recalls; and

(d)keep distributors informed of any monitoring carried out under this regulation.

(2) The importer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

Duty to take action in respect of pressure equipment or assemblies placed on the market considered not to be in conformityE+W+S

27.—(1) An importer who considers, or has reason to believe, that pressure equipment or an assembly which that importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring that pressure equipment or assembly into conformity;

(b)withdraw the pressure equipment or assembly; or

(c)recall the pressure equipment or assembly.

(2) Where the pressure equipment or assembly presents a risk, the importer must immediately inform the market surveillance authority and the competent national authorities F27... of the risk, giving details of—

(a)the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to take action in respect of pressure equipment or assemblies placed on the market considered not to be in conformityN.I.

27.—(1) An importer who considers, or has reason to believe, that pressure equipment or an assembly which that importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring that pressure equipment or assembly into conformity;

(b)withdraw the pressure equipment or assembly; or

(c)recall the pressure equipment or assembly.

(2) Where the pressure equipment or assembly presents a risk, the importer must immediately inform the market surveillance authority and the competent national authorities of any other [F52relevant state] in which the importer made the pressure equipment or assembly available on the market of the risk, giving details of—

(a)the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E31This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Retention of technical documentation and F28... declaration of conformityE+W+S

28.  An importer must, for a period of 10 years beginning on the day on which pressure equipment or an assembly is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to the pressure equipment or assembly—

(a)a copy of the F29... declaration of conformity; and

(b)the technical documentation.

Extent Information

E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Retention of technical documentation and EU declaration of conformityN.I.

28.  An importer must, for a period of 10 years beginning on the day on which pressure equipment or an assembly is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to the pressure equipment or assembly—

(a)a copy of the EU declaration of conformity; and

(b)the technical documentation.

Extent Information

E32This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Provision of information and cooperationE+W+S

29.—(1) Following a request from an enforcing authority, and within such period as the authority may specify, an importer must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day the importer places the pressure equipment or assembly on the market; and

(b)must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a)may be provided electronically; and

(b)[F30must be clear, legible and in easily understandable English].

(4) An importer must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a)evaluate pressure equipment or assemblies in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b)eliminate the risks posed by pressure equipment or assemblies which the importer has placed on the market.

Extent Information

E14This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Provision of information and cooperationN.I.

29.—(1) Following a request from an enforcing authority, and within such period as the authority may specify, an importer must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day the importer places the pressure equipment or assembly on the market; and

(b)must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a)may be provided electronically; and

(b)must be in a language which can be easily understood by the enforcing authority.

(4) An importer must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a)evaluate pressure equipment or assemblies in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b)eliminate the risks posed by pressure equipment or assemblies which the importer has placed on the market.

Extent Information

E33This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

DistributorsU.K.

Duty to act with due careU.K.

30.  When making pressure equipment or an assembly available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.

Requirements which must be satisfied before a distributor makes pressure equipment or assemblies available on the market)E+W+S

31.—(1) Before making pressure equipment or an assembly referred to in regulation 6 or 7 available on the market, the distributor must verify that—

(a)the pressure equipment or assembly—

(i)bears the [F31UK] marking;

(ii)is accompanied by the required documents;

[F32(iii)is accompanied by instructions and safety information that are clear, legible and in easily understandable English;]

(b)the manufacturer has complied with the requirements of regulation 13 (labelling of pressure equipment and assemblies); and

(c)the importer has complied with the requirements of regulation 23 (information identifying importer).

(2) In paragraph (1)(a)(ii), “required documents” means the documents that the manufacturer or importer is required to provide with pressure equipment or assemblies pursuant to—

(a)regulation 13 (labelling of pressure equipment and assemblies);

(b)regulation 23 (information identifying importer);

(c)regulation 14 or 24 (instructions and safety information); and

(d)regulation 49 ([F33UK] marking).

F34(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements which must be satisfied before a distributor makes pressure equipment or assemblies available on the market)N.I.

31.—(1) Before making pressure equipment or an assembly referred to in regulation 6 or 7 available on the market, the distributor must verify that—

(a)the pressure equipment or assembly—

(i)bears the CE marking;

(ii)is accompanied by the required documents;

(iii)the instructions and safety information are in a language which can be easily understood by consumers and other users in the [F53relevant state] in which the pressure equipment or assembly is to be made available on the market;

(b)the manufacturer has complied with the requirements of regulation 13 (labelling of pressure equipment and assemblies); and

(c)the importer has complied with the requirements of regulation 23 (information identifying importer).

(2) In paragraph (1)(a)(ii), “required documents” means the documents that the manufacturer or importer is required to provide with pressure equipment or assemblies pursuant to—

(a)regulation 13 (labelling of pressure equipment and assemblies);

(b)regulation 23 (information identifying importer);

(c)regulation 14 or 24 (instructions and safety information); and

(d)regulation 49 (CE marking).

(3) Where the pressure equipment or assembly is made available on the market in [F54Northern Ireland], the language referred to in paragraph (1)(a)(iii) must be English.

Extent Information

E34This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Storage and transportU.K.

32.  Where a distributor has responsibility for pressure equipment or an assembly referred to in Regulation 6 or 7, the distributor must ensure that the conditions under which the pressure equipment or assembly is stored or transported do not jeopardise its conformity with the essential safety requirements.

Prohibition on making available on the market where pressure equipment or assemblies are not considered to be in conformity with essential safety requirementsU.K.

33.—(1) Where a distributor considers, or has reason to believe, that pressure equipment or an assembly referred to in Regulation 6 or 7 is not in conformity with the essential safety requirements, the distributor must not make the pressure equipment or assembly available on the market until it has been brought into conformity.

(2) Where the pressure equipment or assembly presents a risk, the distributor must inform the following persons of the risk—

(a)the manufacturer or the importer; and

(b)the market surveillance authority.

Duty to take action in respect of pressure equipment made available on the market which are not in conformityE+W+S

34.—(1) A distributor who considers, or has reason to believe, that pressure equipment or assemblies which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to—

(a)bring that pressure equipment or assembly into conformity;

(b)withdraw the pressure equipment or assembly; or

(c)recall the pressure equipment or assembly.

(2) Where the pressure equipment or assembly presents a risk, the distributor must immediately inform the market surveillance authority, and the competent national authorities F35..., of that risk, giving details of—

(a)the respect in which pressure equipment is considered not to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E16This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to take action in respect of pressure equipment made available on the market which are not in conformityN.I.

34.—(1) A distributor who considers, or has reason to believe, that pressure equipment or assemblies which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to—

(a)bring that pressure equipment or assembly into conformity;

(b)withdraw the pressure equipment or assembly; or

(c)recall the pressure equipment or assembly.

(2) Where the pressure equipment or assembly presents a risk, the distributor must immediately inform the market surveillance authority, and the competent national authorities of the [F55relevant states] in which the distributor has made the pressure equipment or assembly available on the market, of that risk, giving details of—

(a)the respect in which pressure equipment is considered not to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E35This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Provision of information and cooperationE+W+S

35.—(1) Following a request from an enforcing authority, and within such period as the authority may specify, a distributor must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) The information referred to in paragraph (1)—

(a)may be provided electronically; and

(b)[F36must be clear, legible and in easily understandable English].

(3) A distributor must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a)evaluate pressure equipment in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b)eliminate the risks posed by pressure equipment or assemblies which the distributor has made available on the market.

Extent Information

E17This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Provision of information and cooperationN.I.

35.—(1) Following a request from an enforcing authority, and within such period as the authority may specify, a distributor must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) The information referred to in paragraph (1)—

(a)may be provided electronically; and

(b)must be in a language which can be easily understood by the enforcing authority.

(3) A distributor must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a)evaluate pressure equipment in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b)eliminate the risks posed by pressure equipment or assemblies which the distributor has made available on the market.

Extent Information

E36This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

All economic operatorsU.K.

Cases in which obligations of manufacturers apply to importers and distributorsU.K.

36.  An importer or distributor (“A”) is to be considered a manufacturer for the purposes of these Regulations, and is subject to the obligations of the manufacturer under this Part, where A—

(a)places pressure equipment or an assembly on the market under A's own name or trademark; or

(b)modifies pressure equipment or an assembly already placed on the market in such a way that it may affect whether the pressure equipment or assembly is in conformity with Part 2.

Translation of F37... declaration of conformityE+W+S

37.—(1) Before making pressure equipment or an assembly available on the market, an economic operator must ensure that the F38... declaration of conformity is [F39in English].

F40(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Translation of EU declaration of conformityN.I.

37.—(1) Before making pressure equipment or an assembly available on the market, an economic operator must ensure that the EU declaration of conformity is prepared in, or translated into, the language required by the [F56relevant state] in which it is to be made available on the market.

(2) Where the pressure equipment or assembly is to be made available on the market in [F57Northern Ireland], the language required is English.

Extent Information

E37This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Identification of economic operatorsU.K.

38.—(1) An economic operator (“E”) who receives a request in relation to pressure equipment or an assembly from the market surveillance authority before the end of the relevant period must, within such period as that authority may specify, identify to the authority—

(a)any other economic operator who has supplied E with the pressure equipment or assembly; and

(b)any other economic operator to whom E has supplied the pressure equipment or assembly.

(2) The relevant period is—

(a)for information under paragraph (1)(a), 10 years beginning on the day on which E was supplied with the pressure equipment or assembly; and

(b)for information under paragraph (1)(b), 10 years beginning on the day on which E supplied the pressure equipment or assembly.

Prohibition on improper use of [F41UK] markingE+W+S

39.—(1) An economic operator must not affix the [F42UK] marking to pressure equipment or an assembly unless—

(a)that economic operator is the manufacturer of the pressure equipment or assembly; and

(b)the conformity of the pressure equipment or assembly with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix the [F42UK] marking to pressure equipment or an assembly where—

(a)the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b)the conformity assessment procedure has been carried out by a user inspectorate.

(3) An economic operator must not affix to pressure equipment or an assembly a marking which—

(a)is not the [F42UK] marking; but

(b)purports to attest that the pressure equipment or assembly is in conformity with the essential safety requirements.

(4) An economic operator must not affix to pressure equipment or an assembly a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F42UK] marking.

(5) An economic operator must not affix to pressure equipment or an assembly any other marking if the visibility, legibility and meaning of the [F42UK] marking would be impaired as a result.

Extent Information

E19This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Prohibition on improper use of CE markingN.I.

39.—(1) An economic operator must not affix the CE marking to pressure equipment or an assembly unless—

(a)that economic operator is the manufacturer of the pressure equipment or assembly; and

(b)the conformity of the pressure equipment or assembly with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix the CE marking to pressure equipment or an assembly where—

(a)the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b)the conformity assessment procedure has been carried out by a user inspectorate.

(3) An economic operator must not affix to pressure equipment or an assembly a marking which—

(a)is not the CE marking; but

(b)purports to attest that the pressure equipment or assembly is in conformity with the essential safety requirements.

(4) An economic operator must not affix to pressure equipment or an assembly a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the CE marking.

(5) An economic operator must not affix to pressure equipment or an assembly any other marking if the visibility, legibility and meaning of the CE marking would be impaired as a result.

Extent Information

E38This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F43Obligations which are met by complying with the obligations in the DirectiveE+W+S

39A.(1) In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b)CE marking” has the meaning given to it in Article 2(31); and

(c)pressure equipment and assemblies” means the pressure equipment and assemblies referred to in Article 4(1) and (2).

(2) Paragraph (3) applies where, before placing pressure equipment or an assembly on the market, the manufacturer—

(a)ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I;

(b)ensures that the relevant conformity assessment procedures referred to in Article 14 have been carried out;

(c)draws up the technical documentation referred to in Annex III;

(d)ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(e)affixes a CE marking and the identification number of the notified body (where that body is involved in the product control phase) in accordance with Articles 18 and 19(1) to (4);

(f)draws up an EU declaration of conformity, in accordance with Article 17; and

(g)ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a)the requirements of regulations 9(1), 10 and 11(1) are to be treated as being satisfied;

(b)regulations 2(2)(a), 11(3), 12, 15(2), 19(2) and 39 apply subject to the modifications in paragraph (8); and

(c)Part 3 does not apply;

(d)regulation 74 does not apply.

(4) Paragraph (5) applies where, before placing pressure equipment or an assembly on the market, the importer ensures that—

(a)the relevant conformity assessment procedure referred to in Article 14 has been carried out;

(b)the manufacturer has drawn up the technical documentation referred to in Annex III; and

(c)the pressure equipment or assembly bears the CE marking and any notified body identification number.

(5) Where this paragraph applies—

(a)the requirements of regulation 21(1)(a) to (c) are to be treated as being satisfied; and

(b)regulations 2(2)(a), 22(1), 25 and 28 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making pressure equipment or an assembly available on the market, a distributor ensures that the pressure equipment or assembly bears the CE marking.

(7) Where this paragraph applies—

(a)regulation 31(1)(a)(i) is to be treated as being satisfied; and

(b)regulations 2(2)(a) and 33(1) apply subject to the modifications in paragraph (8).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (7)(b) are that—

(a)any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b)any reference to “UK marking” is to be read as a reference to the CE marking;

(c)any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I;

(d)any reference to “designated standard” is to be read as a reference to a harmonised standard within the meaning of Article 2(24); and

(e)any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 14.

Conformity assessment procedure obligation which is met by complying with the Directive.E+W+S

39B .(1) In this regulation any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive.

(2) Paragraph (3) applies where, prior to the manufacture of pressure equipment or an assembly, the manufacturer ensures that the conformity assessment procedure that applies to that pressure equipment or assembly in accordance with Article 14(2), referred to as Module B and set out in Annex III, has been carried out.

(3) Where this paragraph applies—

(a)the requirement in regulation 42 to follow the conformity assessment procedure referred to in that regulation as Module B is to be treated as being satisfied;

(b)any reference to “relevant conformity assessment procedure” in regulations 10(1)(c), 11(1), 21(1)(a), 39(1)(b) and 48(b) is to be read as including the conformity assessment procedure referred to in Article 14(2), referred to as Module B and set out in Annex III; and

(c)any reference to “technical documentation” in regulations 10(1)(d), 21(1)(b) and 28(b) is to be read as including the technical documentation relating to the design of the pressure equipment or assembly referred to as Module B as set out in Annex III.

Expiry of regulations 39A and 39BE+W+S

39C.(1) Subject to paragraph (2), regulation 39A ceases to have effect at the end of the period of [F44four years] beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 39A—

(a)any pressure equipment or assembly which was placed on the market pursuant to regulation 39A may continue to be made available on the market on or after the expiry of regulation 39A;

(b)any obligation to which a person was subject under regulation 39A in respect of any pressure equipment or assembly placed on the market pursuant to regulation 39A continues to have effect after the expiry of regulation 39A, in respect of that equipment or assembly.

(3) Subject to paragraph (4), regulation 39B ceases to have effect at the end of the period of [F45four years] beginning with IP completion day.

(4) Where a conformity assessment procedure has been completed pursuant to regulation 39B in relation to a pressure equipment or an assembly prior to the expiry of regulation 39B, regulation 39B continues to apply in respect of that pressure equipment or assembly where—

(a)the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body;

(b)the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and

(c)the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate.

(5) In paragraph (4) “EU-Type examination certificate” means a certificate issued after the conformity assessment referred to in the Directive as Module B and set out in Annex III of the Directive, has been carried out.

Qualifying Northern Ireland GoodsE+W+S

39D.(1) Where paragraph (2) applies any pressure equipment or assembly is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a)any pressure equipment or assembly—

(i)is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii)is qualifying Northern Ireland goods; and

(b)an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the pressure equipment or assembly on the market, the importer—

(a)complies with regulation 23;

(b)ensures that—

(i)the relevant conformity assessment procedure has been carried out in accordance with Part 3, as that Part applies in Northern Ireland;

(ii)the manufacturer has drawn up the technical documentation; and

(iii)the pressure equipment or assembly bears the CE marking.

(4) In this regulation—

CE marking” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

technical documentation” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.]

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