Legalize / United Kingdom / Statutory-Instrument

The Pressure Equipment (Safety) Regulations 2016

Type Statutory-Instrument

Publication 2016-11-15

Last updated 2024-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Reform history JSON API

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation, a reference to a “product” is a reference to a product to which these Regulations apply.

(9) The Secretary of State may be regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(10) Regulations made under paragraph (9) are to be made by statutory instrument.

(11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Pressure equipment and assemblies

Excluded pressure equipment and assemblies

Exception for trade fairs, exhibitions and demonstrations

Pressure equipment and assemblies subject to essential safety requirements

Requirement for pressure equipment and assemblies to comply with sound engineering practice

Power to reclassify pressure equipment and assemblies

8A

(1) Where the condition in paragraph (2) is met, the Secretary of State may by regulations make provision that pressure equipment or assemblies referred to in regulation 8 are to satisfy the essential requirements in Schedule 2.

(2) The condition referred to in paragraph (1) is that the Secretary of State considers that the provision is required to mitigate the effects of very serious safety concerns.

(3) Regulations made under paragraph (1)—

(a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and

(b) include power—

(i) to make different provision for different cases; and

(ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

Declaration of conformity and UK marking

Translation of ... declaration of conformity

Prohibition on improper use of UK marking

Obligations which are met by complying with the obligations in the Directive

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;

(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

(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

(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.

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 39B

39C

(1) In this regulation—

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

(b) “pressure equipment or assembly” means the pressure equipment or assembly referred to in Article 4(1) and (2);

(2) Paragraph (3) applies where, before placing pressure equipment or 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 that apply to that pressure equipment or assembly referred to in Article 14 have been carried out;

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

(3) Where this paragraph applies—

(a) regulations 9(1) and 10 are to be treated as being satisfied;

(b) except for regulations 48 and 49(1) to (5), Part 3 does not apply;

(c) regulations 2(2)(a), 12, 15, 21(1)(a) and (b), 22, 25, 31, 32, 33 and 39 apply subject to the modifications in paragraph (4);

(d) regulations 11, 14, 24, 48 and 49(2) and Schedule 11 are subject to the modifications in paragraphs (4) and (5).

(4) The modifications referred to in paragraph (3)(c) and (d) are that—

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

(b) any reference to “designated standard” is to be read as a reference to a harmonised standard;

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

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III;

(e) any reference to “pressure equipment or an assembly referred to in regulation 6 or 7” is to be read as a reference to pressure equipment or assembly referred to in Article 4(1) or (2).

(5) The modifications referred to in paragraph (3)(d) are that—

(a) in regulation 11—

(i) paragraph (1) is to be read as if sub-paragraph (c) were omitted;

(ii) in paragraph (4) the reference to “enactment” is to be read as including the Directive;

(b) in regulations 14 and 24 any reference to paragraphs 29 and 30 of Schedule 2 is to be read as a reference to paragraphs 3.3 and 3.4 of Annex I;

(d) in regulation 49(2)—

(i) the reference to “regulation 42” is to be read as a reference to Article 14;

(ii) the reference to “user inspectorate” is to be read as a reference to any body designated in accordance with Article 16;

(e) in Schedule 11—

(i) in paragraph 5 the reference to “statutory requirements” is to be read as including a reference to the Directive;

(ii) paragraph 7 is to be read as requiring the manufacturer to include the details set out in paragraph 7 of Annex IV.

Qualifying Northern Ireland Goods

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.

Power to amend applicable module

42A

(1) Where in order to mitigate the effects of very serious safety concerns the Secretary of State considers that an item or family of pressure equipment are to be subject to different categories of modules, the Secretary of State may by regulations make such provision.

(2) Regulations made under paragraph (1)—

(a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and

(b) include power—

(i) to make different provision for different cases; and

(ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

... Declaration of conformity

UK marking

UK(NI) indication

49A

(1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the pressure equipment or assembly, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a) visibly, legibly and indelibly; and

(b) before pressure equipment or an assembly is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 49.

(4) The UK(NI) indication must be affixed by—

(a) the manufacturer; or

(b) the manufacturer's authorised representative.

(5) When placing pressure equipment or an assembly on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

Register of notified bodies established in the United Kingdom

49B

(1) The Secretary of State must ensure that—

(a) each notified body established in the United Kingdom is assigned an identification number; and

(b) there is a register of—

(i) notified bodies established in the United Kingdom;

(ii) their notified body identification number;

(iii) the activities for which they have been notified;

(iv) any restrictions on those activities.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

European approval for materials

Approved bodies

Approval of conformity assessment bodies

Approval of approved bodies

Approval of recognised third party organisations

Approval of user inspectorates

Presumption of conformity of conformity assessment bodies

Monitoring

Restriction, suspension or withdrawal of approval (approved bodies and recognised third party organisations)

Restriction, suspension or withdrawal of approval (user inspectorates)

Operational matters in relation to approved bodies, recognised third party organisations and user inspectorates

Subsidiaries and contractors

Register of approved bodies

United Kingdom Accreditation Service

Transitional provision in relation to EU Exit

88A

(1) In this regulation—

“pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day;

“product” means pressure equipment or an assembly required, under regulation 6 or 7, to satisfy the essential safety requirements set out in Schedule 2 to which these Regulations apply on or after IP completion day.

(2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 24 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product.

(3) Paragraph (2) does not apply to—

(a) any obligation of any enforcing authority to inform the European Commission or the member States of any matter; or

(b) any obligation to take action outside of the United Kingdom in respect of that product.

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

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

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocations, amendments and savings

SCHEDULE 1A — Conformity Assessment Procedures for Pressure Equipment and Assemblies

PART 1 — Module A: Internal Production Control

General

1

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4 and ensures and declares on their sole responsibility that the pressure equipment concerned satisfy the requirements of these Regulations.

Technical documentation

2

(1) The manufacturer shall establish the technical documentation.

(2) The technical documentation shall—

(a) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements;

(b) include an adequate analysis and assessment of the risk;

(i) a general description;

(ii) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, and all other relevant parts, to component level;

(iii) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment;

(iv) a list of the designated standards;

(v) results of design calculations made, examinations carried out and the results of any other relevant calculation or examination;

(vi) test reports;

(vii) manufacture; and

(viii) operation,

of the pressure equipment or assembly.

(3) The technical documentation must be kept at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Manufacturing

3

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in paragraph 2 and the requirements of these Regulations.

UK marking and declaration of conformity

4

The manufacturer shall—

(a) affix the UK marking to each individual piece of pressure equipment, or assembly, that satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Authorised representative

5

The manufacturer's obligations set out in paragraph 4 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 2 — Module A2: Internal production control plus supervised pressure equipment checks at random

General

6

Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 ,4 and 5, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned satisfies the requirements of these Regulations.

Technical documentation

7

(1) The manufacturer shall establish the technical documentation.

(2) The technical documentation shall—

(a) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements;

(b) include an adequate analysis and assessment of the risk;

(i) a general description;

(ii) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, and all other relevant parts, to component level;

(iii) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment;

(iv) a list of the designated standards;

(v) results of design calculations made, examinations carried out, and the results of any other relevant calculation or examination;

(vi) test reports;

(vii) manufacture; and

(viii) operation

of the pressure equipment or assembly.

(4) The technical documentation must be kept at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Manufacturing

8

Final assessment and pressure equipment, assembly, checks

9

(1) The manufacturer shall perform a final assessment of the pressure equipment, or assembly, monitored by means of unexpected visits by an approved body chosen by the manufacturer.

(2) The approved body shall carry out, or have carried out for them, product checks which shall—

(a) be carried out at random intervals determined by the approved body;

(b) verify the quality of the internal checks of the pressure equipment, or assembly (taking into account the technological complexity of the equipment, or assembly, and the quantity of production);

(c) establish that the manufacturer performs final assessment in accordance with paragraphs 25 to 28 of Schedule 2 to these Regulations;

(d) take samples of pressure equipment and assemblies at the manufacturing or storage premises in order to conduct checks (the approved body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the samples).

(3) The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment, or assembly, performs within acceptable limits, with a view to ensuring conformity of the pressure equipment, or assembly.

(4) The approved body shall take appropriate measures where an item of pressure equipment or assembly does not conform.

(5) The manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process.

UK marking and declaration of conformity

10

The manufacturer shall—

(a) affix the UK marking to each individual pressure equipment, or assembly, that satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Authorised representative

11

The manufacturer's obligations set out in paragraph 10 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 3 — Module B: Type examination

Type examination–production type

12

Type examination–production type is the part of a conformity assessment procedure in which an approved body examines the technical design of the pressure equipment, or assembly, and verifies and attests that the technical design of the pressure equipment meets the requirements of these Regulations.

13

Type examination–production type shall consist of an assessment of the adequacy of the technical design of the pressure equipment, or assembly, through examination of the technical documentation and supporting evidence referred to in paragraph 14, plus examination of a specimen, representative of the production envisaged, of the complete pressure equipment or assembly.

14

The manufacturer shall lodge an application with a single approved body of their choice. The application shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;

(b) a written declaration that the same application had not been lodged with any other approved body;

(i) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements;

(ii) include an adequate analysis and assessment of the risk;

(iii) specify the applicable requirements and contain, where applicable—

(aa) a general description;

(bb) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, and all other relevant parts, to component level;

(cc) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment;

(dd) a list of the designated standards;

(ee) results of design calculations made, examinations carried out, and the results of any other relevant calculation or examination;

(ff) test reports;

(gg) information concerning the tests provided for in manufacture;

(hh) information concerning the qualifications and approvals required under paragraphs 21 and 22 of Schedule 2 (essential safety requirements);

(ii) manufacture; and

(jj) operation;

(d) specimens representative of the product envisaged which—

(i) may cover several versions of the pressure equipment or assembly (provided that the differences between the versions do not affect the level of safety);

(ii) the approved body may request further of, if needed for carrying out the test programme;

(e) supporting evidence for the adequacy of the technical design solution which shall—

(i) mention any documents that have been used, in particular where the relevant designated standards have not been applied in full; and

(ii) include, where necessary, the results of tests carried out—

(aa) by the appropriate laboratory of the manufacturer applying other relevant technical specifications; or

(bb) by any other testing laboratory on their behalf and under their responsibility.

15

The approved body shall—

(a) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the pressure equipment, or assembly, and the manufacturing procedures;

(b) where the materials are not in conformity with the relevant designated standards, assess the materials and check the certificate issued by the material manufacturer in accordance with subparagraphs 31(5) to (8) of Schedule 2 to these Regulations;

(c) approve the procedures for the permanent joining of pressure equipment, or assembly, parts, or check that they have been previously approved in accordance with paragraph 21 of Schedule 2 to these Regulations;

(d) verify that the personal undertaking in the permanent joining of pressure equipment, or assembly, parts and the non-destructive tests are qualified or approved in accordance with paragraphs 21 or 22 of Schedule 2 to these Regulations;

(e) verify that the specimens have been manufactured in conformity with the technical documents and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards as well as the elements which have been designed using other relevant technical specifications without applying the relevant provisions of those standards;

(f) carry out appropriate examinations and necessary tests to check whether—

(i) when the manufacturer has chosen to apply the solutions in the relevant designated standards, these have been applied correctly;

(ii) where the solutions in the relevant designated standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of these Regulations;

(g) agree, with the manufacturer, on a location where the examinations and tests will be carried out;

(h) draw up an evaluation report—

(i) recording the activities undertaken, in accordance with this paragraph, and their outcomes; and

(ii) only release the content, in full or in part, with the agreement of the manufacturer.

16

Where the type meets the requirements of these Regulations, the approved body shall issue a Type examination–production type certificate to the manufacturer.

17

The Type examination-production type certificate shall—

(a) include—

(i) the name and address of the manufacturer;

(ii) the conclusions of the examination;

(iii) any conditions for the certificate's validity; and

(iv) necessary data for identification of the approved type;

(b) include an annex listing the relevant parts of the technical documentation, a copy of which shall be kept by the approved body;

(c) contain all relevant information to allow the conformity of manufactured equipment pressure equipment, or assemblies, with the examined type to be evaluated and to allow for in-service control;

(d) be valid for 10 years, without prejudice to paragraphs 20 and 21, and be renewable.

18

Where the type does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a Type examination-production type certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

19

Provision shall be made for an appeals procedure.

20

The approved body shall keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

21

The manufacturer shall inform the approved body that holds the technical documentation relating to the Type examination-production type certificate of all modifications to the approved type that may affect the conformity of the pressure equipment, or assembly, with the essential safety requirements of these Regulations or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original Type examination-production type certificate.

22

Each approved body shall inform the Secretary of State concerning Type examination-production type certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the enforcing authorities the list of certificates and any additions thereto refused, suspended or otherwise restricted.

23

Each approved body shall inform the other approved bodies concerning the Type examination-production type certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning the certificates and additions thereto that it has issued.

24

Other approved bodies may, on request, obtain a copy of the Type examination-production type certificate and additions thereto.

25

The approved body shall keep a copy of the Type examination-production type certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

26

The manufacturer shall keep a copy of the Type examination-production type certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

27

The manufacturer's authorised representative may lodge the application referred to in paragraph 14 and fulfil the obligations set out in paragraphs 21 and 26, provided that they are specified in the mandate.

Type examination–design type

28

Type examination-design type is the part of a conformity assessment procedure in which an approved body examines the technical design of the pressure equipment, or assembly, and verifies and attests that the technical design of the pressure equipment, or assembly, meets the requirements of these Regulations.

29

Type examination-design type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in paragraph 31, without examination of a specimen.

30

The experimental design method provided for at paragraph 6 of Schedule 2 to these Regulations shall not be used in the context of this module.

31

The manufacturer shall lodge an application with a single approved body of their choice. The application shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;

(b) a written declaration that the same application had not been lodged with any other approved body;

(i) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements;

(ii) include an adequate analysis and assessment of the risk;

(iii) specify the applicable requirements and contain, where applicable—

(aa) a general description;

(bb) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits and all other relevant parts, to component level;

(cc) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment;

(dd) a list of the designated standards;

(ee) information concerning the qualifications and approvals required under paragraphs 21 and 22 of Schedule 2;

(d) supporting evidence for the adequacy of the technical design solution which shall—

(i) mention any documents that have been used, in particular where the relevant designated standards have not been applied in full; and

(ii) include, where necessary, the results of tests carried out—

(aa) by the appropriate laboratory of the manufacturer applying other relevant technical specifications; or

(bb) by any other testing laboratory on their behalf and under their responsibility.

32

The application may cover several versions of the pressure equipment, or assembly, provided that the differences between the versions do not affect the level of safety.

33

The approved body shall—

(a) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product;

(b) assess the materials where they are not in conformity with the relevant designated standards;

(c) approve the procedures for the permanent joining of pressure equipment, or assembly, parts or check that they have been previously approved in accordance with paragraph 21 of Schedule 2 to these Regulations;

(d) carry out appropriate examinations and necessary tests to check whether—

(i) when the manufacturer has chosen to apply the solutions in the relevant designated standards, these have been applied correctly;

(ii) where the solutions in the relevant designated standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of these Regulations;

(e) draw up an evaluation report—

(i) recording the activities undertaken, in accordance with this paragraph, and their outcomes;

(ii) only release the content, in full or in part, with the agreement of the manufacturer.

34

Where the design meets the requirements of these Regulations, the approved body shall issue a Type examination–design type certificate to the manufacturer.

35

The Type examination-design certificate type shall—

(a) include—

(i) the name and address of the manufacturer;

(ii) the conclusions of the examination;

(iii) any conditions for the certificate's validity; and

(iv) necessary data for identification of the approved type;

(b) include an annex listing the relevant parts of the technical documentation, a copy of which shall be kept by the approved body;

(c) contain all relevant information to allow the conformity of manufactured pressure equipment, or assemblies, with the examined design to be evaluated and to allow for in-service control;

(d) be valid for 10 years, without prejudice to paragraphs 36 and 37, and be renewable.

36

Where the design does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a Type examination-design type certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

37

The approved body shall keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of these Regulations and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

38

The manufacturer shall inform the approved body that holds the technical documentation relating to the Type examination-design type certificate of all modifications to the approved type that may affect the conformity of the pressure equipment, or assembly, with the essential safety requirements of these Regulations or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original Type examination-design type certificate.

39

Each approved body shall inform its approved authority concerning Type examination-design type certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its approved authorities the list of certificates and any additions thereto refused, suspended or otherwise restricted.

40

Each approved body shall inform the other approved bodies concerning the Type examination-design type certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning the certificates and additions thereto that it has issued.

41

Other approved bodies may, on request, obtain a copy of the Type examination-design type certificate and additions thereto.

42

The approved body shall keep a copy of the Type examination-design type certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

43

The manufacturer shall keep a copy of the Type examination-design type certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

44

The manufacturer's authorised representative may lodge the application referred to in paragraph 31 and fulfil the obligations set out in paragraphs 37 and 42, provided that they are specified in the mandate.

PART 4 — Module C2: Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals

General

45

Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 46, 47 and 48, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned is in conformity with the type described in the Type examination certificate and satisfies the requirements of these Regulations that apply to it.

Manufacturing

46

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment, or assembly, with the type described in the Type examination certificate and with the requirements of these Regulations.

Final assessment and pressure equipment check

47

(1) The manufacturer shall choose an approved body to carry out checks, or have them carried out, at random intervals determined by that body.

(2) Checks carried out by the approved body shall—

(a) verify the quality of the final assessment;

(b) verify the quality of the internal checks,

taking into account the technological complexity of the pressure equipment, or assembly, and the quantity of production.

(3) The approved body shall establish that the manufacturer actually performs the final assessment in accordance with paragraphs 25 to 28 of Schedule 2 to these Regulations.

(4) An adequate sample of the final pressure equipment, or assembly, taken on-site by the approved body before placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the designated standards, or equivalent test applying other technical specifications, shall be carried out to check the conformity of the pressure equipment, or assembly, with the relevant requirements of these Regulations.

(5) The approved body shall assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment on pressure equipment, or assembly, samples.

(6) Where a sample does not conform to the acceptable quality level, the approving body shall take appropriate measures.

(7) The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment or assembly.

(8) Where the tests are carried out by an approved body, the manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process.

UK marking and declaration of conformity

48

The manufacturer shall—

(a) affix the UK marking to each individual pressure equipment, or assembly, that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Authorised representative

49

The manufacturer's obligations set out in paragraph 47 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 5 — Module D: Conformity to type based on quality assurance in the production process

General

50

Conformity to type based on quality assurance in the production process is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 51 and 54 and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned is in conformity with the type described in the Type examination certificate and satisfies the requirements of these Regulations that apply to it.

Manufacturing

51

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment, or assembly, concerned as specified in paragraph 52 and shall be subject to surveillance as specified in paragraph 53.

Quality system

52

(1) The manufacturer shall lodge an application for assessment of their quality system with the approved body of their choice for the pressure equipment, or assembly, concerned.

(2) The application shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;

(b) a written declaration that the same application has not been lodged with any other approved body;

(d) the documentation concerning the quality; and

(e) the technical documentation of the approved type and a copy of the Type examination certificate.

(3) The quality system shall ensure that the pressure equipment is in conformity with the type described in the Type examination certificate and comply with the requirements of these Regulations.

(4) All elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records, including—

(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment or assembly;

(b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with paragraph 21 of Schedule 2 to these Regulations;

(c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(d) the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications and approvals of the personnel concerned, particularly of those of the personnel undertaking the permanent joining of parts and the non-destructive test in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations; and

(e) the means of monitoring the achievement of the required quality and the effective operation of the quality system.

(5) The approved body shall—

(a) assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) and (4);

(b) presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard;

(d) ensure that the audit—

(i) is carried out by a team containing at least one member with experience in the relevant pressure equipment, or assembly, field and pressure equipment and assembly technology concerned, and knowledge of the applicable requirements of these Regulations;

(ii) includes an inspection visit to the manufacturer's premises;

(iii) reviews the technical documentation referred to in paragraph 52, to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(6) The decision shall—

(a) be notified to the manufacturer;

(b) contain the conclusions of the audit; and

(7) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(8) Where the manufacturer intends to change the quality system—

(a) the manufacturer shall inform the approved body that has approved the quality system informed of the intended change to the quality system;

(b) the approved body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (5) or whether a reassessment is necessary;

(d) the notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

53

(1) The manufacturer shall—

(a) allow the approved body access to the manufacture, inspection, testing and storage sites for assessment;

(b) provide the quality system documentation;

(c) provide the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned;

(d) provide any other information deemed necessary by the approved body.

(2) The approved body shall—

(a) carry our periodic audits to make sure that the manufacturer maintains and applies the quality system;

(b) provide the manufacturer with an audit report;

(3) The approved body may pay unexpected visits to the manufacturer. The need for such additional visits, and their frequency, will be determined on the basis of a visit control system operated by the approved body. The following factors shall be considered in the visit control system—

(a) the category of the pressure equipment or assembly;

(b) the results of previous surveillance visits;

(d) special conditions linked to the approval of the system, where applicable; and

(e) significant changes in manufacturing organisation, policies or techniques.

(4) During unexpected visits the approved body—

(a) may carry out product tests or have them carried out, where necessary, in order to verify that the quality system is functioning correctly;

(b) shall provide the manufacturer with a visit report; and

UK marking and declaration of conformity

54

(1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 51(1), the latter's identification number, to each individual piece of pressure equipment, or assembly, that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market;

(e) for a period ending 10 years after the pressure equipment, or assembly, has been placed on the market, keep at the disposal of the national authorities—

(i) the documentation referred to in paragraph 52(1);

(ii) any change referred to in paragraph 52(8)(a), as approved; and

(iii) the decisions and reports of the approved body referred to in paragraphs 52(6) and (8) and 53(2) to (4),

(2) Each approved body shall inform the Secretary of State of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

(3) Each approved body shall inform the other approved bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

Authorised representative

55

The manufacturer's obligations set out in paragraph 52(1) and (8) and paragraph 54 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 6 — Module D1: Quality assurance of the production process

General

56

Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 57, 58 and 61, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned satisfies the requirements of these Regulations.

Technical documentation

57

(1) The manufacturer shall establish the technical documentation.

(2) The technical documentation shall—

(a) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements;

(b) include an adequate analysis and assessment of the risk;

(i) a general description of the individual piece of equipment or the assembly;

(ii) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits and all other relevant parts, to component level;

(iii) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment;

(iv) a list of the designated standards;

(v) results of design calculations made, examinations carried out the results of any other relevant calculation or examination; and

(vi) test reports.

(3) The technical documentation must be kept at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Manufacturing

58

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment, or assembly, concerned as specified in paragraph 59 and shall be subject to surveillance as specified in paragraph 60.

Quality system

59

(1) The manufacturer shall lodge an application for assessment of their quality system with the approved body of their choice for the pressure equipment, or assembly, concerned.

(2) The application shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;

(b) a written declaration that the same application has not been lodged with any other approved body;

(d) the documentation concerning the quality system; and

(e) the technical documentation referred to in paragraph 57.

(3) The quality system shall ensure compliance of the pressure equipment, or assembly, with the requirements of these Regulations that apply to it.

(4) All elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records, including—

(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment or assembly;

(b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with paragraph 21 of Schedule 2 to these Regulations;

(c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(d) the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications and approvals of the personnel concerned, particularly of those of the personnel undertaking the permanent joining of parts and the non-destructive test in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations; and

(e) the means of monitoring the achievement of the required quality and the effective operation of the quality system.

(5) The approved body shall—

(a) assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) and (4);

(b) presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard;

(d) ensure that the audit—

(i) is carried out by a team containing at least one member with experience in the relevant pressure equipment, or assembly, field and pressure equipment and assembly technology concerned, and knowledge of the applicable requirements of these Regulations;

(ii) includes an inspection visit to the manufacturer's premises; and

(iii) reviews the technical documentation referred to in paragraph 56, to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(6) The decision shall—

(a) be notified to the manufacturer;

(b) contain the conclusions of the audit; and

(7) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(8) Where the manufacturer intends to change the quality system—

(a) the manufacturer shall inform the approved body that has approved the quality system informed of the intended change to the quality system;

(b) the approved body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (5) or whether a reassessment is necessary;

(d) the notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

60

(1) The manufacturer shall—

(a) allow the approved body access to the manufacture, inspection, testing and storage sites for assessment;

(b) provide the quality system documentation;

(d) provide the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;

(e) provide any other information deemed necessary by the approved body.

(2) The approved body shall—

(a) carry our periodic audits to make sure that the manufacturer maintains and applies the quality system;

(b) provide the manufacturer with an audit report;

(3) The approved body may pay unexpected visits to the manufacturer. The need for such additional visits, and their frequency, should be determined on the basis of a visit control system operated by the approved body. The following factors shall be considered in the visit control system—

(a) the category of the pressure equipment or assembly;

(b) the results of previous surveillance visits;

(d) special conditions linked to the approval of the system, where applicable; and

(e) significant changes in manufacturing organisation, policies or techniques.

(4) During unexpected visits, the approved body—

(a) may carry out product tests or have them carried out, where necessary, in order to verify that the quality system is functioning correctly;

(b) shall provide the manufacturer with a visit report; and

UK marking and declaration of conformity

61

(1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 58(1), the latter's identification number, to each individual piece of pressure equipment, or assembly, that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market;

(e) For a period ending 10 years after the pressure equipment, or assembly, has been placed on the market, keep at the disposal of the national authorities—

(i) the documentation referred to in paragraphs 59(1) and (2);

(ii) the change referred to in paragraph 59(8); and

(iii) the decisions and reports of the approved body referred to in paragraphs 58(8) and 60(2) to (4),

(2) Each approved body shall inform the Secretary of State of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

(3) Each approved body shall inform the other approved bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

Authorised representative

62

The manufacturer's obligations set out in paragraphs 59(1), (2) and (8) and paragraph 61 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 7 — Module E: Conformity to type based on pressure equipment quality assurance

General

63

Conformity to type based on pressure equipment quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 64 and 67, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned is in conformity with the type described in the Type examination certificate and satisfies the requirements of these Regulations.

Manufacturing

64

The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment, or assembly, concerned as specified in paragraph 65 and shall be subject to surveillance as specified in paragraph 66.

Quality system

65

(1) The manufacturer shall lodge an application for assessment of their quality system with the approved body of their choice for the pressure equipment, or assembly, concerned.

(2) The application shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;

(b) a written declaration that the same application has not been lodged with any other approved body;

(d) the documentation concerning the quality system;

(e) the technical documentation of the approved type and a copy of the Type examination certificate.

(3) The quality system shall ensure compliance of the products with the type described in the Type examination certificate and with the applicable requirements of these Regulations.

(4) All elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records, including—

(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment or assembly;

(b) the examinations and tests that will be carried out after manufacture;

(c) the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications and approvals of the personnel concerned, particularly of those of the personnel undertaking the permanent joining of parts and the non-destructive test in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations; and

(d) the means of monitoring the effective operation of the quality system.

(5) The approved body shall—

(a) assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) and (4);

(b) presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard;

(d) ensure that the audit—

(i) is carried out by a team containing at least one member with experience in the relevant pressure equipment, or assembly, field and pressure equipment and assembly technology concerned, and knowledge of the applicable requirements of these Regulations;

(ii) includes an inspection visit to the manufacturer's premises;

(iii) reviews the technical documentation referred to in paragraph 65(2)(e), to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(6) The decision shall—

(a) be notified to the manufacturer;

(b) contain the conclusions of the audit; and

(7) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(8) Where the manufacturer intends to change the quality system—

(a) the manufacturer shall inform the approved body that has approved the quality system informed of the intended change to the quality system;

(b) the approved body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (5) or whether a reassessment is necessary;

(d) the notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

66

(1) The manufacturer shall—

(a) allow the approved body access to the manufacture, inspection, testing and storage sites for assessment;

(b) provide the quality system documentation;

(d) provide the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;

(e) provide any other information deemed necessary by the approved body.

(2) The approved body shall—

(a) carry our periodic audits to make sure that the manufacturer maintains and applies the quality system;

(b) provide the manufacturer with an audit report;

(3) The approved body may pay unexpected visits to the manufacturer. The need for such additional visits, and their frequency, should be determined on the basis of a visit control system operated by the approved body. The following factors shall be considered in the visit control system—

(a) the category of the pressure equipment or assembly;

(b) the results of previous surveillance visits;

(d) special conditions linked to the approval of the system, where applicable; and

(e) significant changes in manufacturing organisation, policies or techniques.

(4) During unexpected visits, the approved body—

(a) may carry out product tests or have them carried out, where necessary, in order to verify that the quality system is functioning correctly;

(b) shall provide the manufacturer with a visit report; and

UK marking and declaration of conformity

67

(1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 65(1), the latter's identification number, to each individual piece of pressure equipment, or assembly, that is conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market;

(e) for a period ending 10 years after the pressure equipment, or assembly, has been placed on the market, keep at the disposal of the national authorities—

(i) the documentation referred to in paragraphs 65(1) and (2);

(ii) the change referred to in paragraph 65(8); and

(iii) the decisions and reports of the approved body referred to in paragraphs 65(5) and (8) and 66(2) and (3).

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