Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) Text with EEA relevance

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to check the conformity of the pressure equipment with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

The examinations and tests to check the conformity of the pressure equipment with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4.

• 1. Verification of conformity by examination and testing of every item of pressure equipment

• 4.1.All pressure equipment shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) or equivalent tests shall be carried out in order to verify conformity with the approved type and described in the EU-type examination certificate and with the appropriate requirements of this Directive. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

• In particular, the notified body shall:

• — verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 and 3.1.3 of Annex I,

• — verify the certificate issued by the materials manufacturer in accordance with point 4.3 of Annex I,

• — carry out or have carried out the final inspection and proof test referred to in point 3.2 of Annex I and examine the safety devices, if applicable.

• 4.2.The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment.

• The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the pressure equipment has been placed on the market.

• 1. CE marking and EU declaration of conformity

• 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual item of pressure equipment that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

• 5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities, for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

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

• If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the pressure equipment.

• 1. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the pressure equipment during the manufacturing process.

• 1. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.

10. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

• 1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.

• 1. Technical documentation

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4.

The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment.

The technical documentation shall, wherever applicable, contain at least the following elements:

• — a general description of the pressure equipment,

• — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• — descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,

• — a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards, have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

• — results of design calculations made, examinations carried out, etc.,

• — test reports,

• — appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with points 3.1.2 and 3.1.3 of Annex I.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market.

• 1. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the applicable requirements of this Directive.

• 1. Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standard(s) and/or equivalent tests, to check the conformity of the pressure equipment with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out applying other technical specifications.

In particular the notified body shall:

• — examine the technical documentation with respect to the design and the manufacturing procedures,

• — assess the materials used where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,

• — approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with point 3.1.2 of Annex I,

• — verify the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,

• — carry out the final inspection referred to in point 3.2.1 of Annex I, perform or have performed the proof test referred to in point 3.2.2 of Annex I, and examine the safety devices, if applicable.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved pressure equipment, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.

• 1. CE marking and EU declaration of conformity

• 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each item of pressure equipment that satisfies the applicable requirements of this Directive.

• 5.2.The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

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

• 1. Authorised representative

The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

11. MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE

• 1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfies the requirements of this Directive that apply to it.

• 1. Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the pressure equipment as specified in point 3 and shall be subject to surveillance as specified in point 4.

• 1. Quality system

• 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned.

• The application shall include:

• — the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

• — the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements: — a general description of the pressure equipment, — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., — descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment, — a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, — results of design calculations made, examinations carried out, etc., — test reports,

• — the documentation concerning the quality system, and

• — a written declaration that the same application has not been lodged with any other notified body.

• 3.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

• All the 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. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

• It shall, in particular, contain an adequate description of:

• — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,

• — the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the pressure equipment will be met,

• — the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point 4 of Annex I,

• — the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

• — the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,

• — the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,

• — the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.

• 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

• In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

• The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

• The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

• 3.4.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.

• 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

• The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

• It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

• 1. Surveillance under the responsibility of the notified body

• 4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

• 4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

• — the quality system documentation,

• — the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

• — the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

• 4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

• 4.4.In addition, the notified body may pay unexpected visits to the manufacturer.

• The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system:

• — the category of the equipment,

• — the results of previous surveillance visits,

• — the need to follow up corrective action(s),

• — special conditions linked to the approval of the system, where applicable,

• — significant changes in manufacturing organisation, policy or techniques.

• During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

• 1. CE marking and EU declaration of conformity

• 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.

• 5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.

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

• 1. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

• — the technical documentation referred to in point 3.1,

• — the documentation concerning the quality system referred to in point 3.1,

• — the change referred to point 3.4, as approved,

• — the decisions and reports of the notified body referred to in points 3.3, 3.4, 4.3 and 4.4.

• 1. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

• 1. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

12. MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

• 1. Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive that apply to it.

• 1. Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the pressure equipment shall have been examined in accordance with point 4.

• 1. Quality system

• 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the pressure equipment concerned.

• The application shall include:

• — the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

• — the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation shall, wherever applicable, contain at least the following elements: — a general description of the pressure equipment, — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., — descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment, — a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, — results of design calculations made, examinations carried out, etc., — test reports,

• — the documentation concerning the quality system,

• — a written declaration that the same application has not been lodged with any other notified body.

• 3.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

• All the 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.

• It shall, in particular, contain an adequate description of:

• — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,

• — the technical design specifications, including standards, that will be applied and, where relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential safety requirements of the Directive that apply to the pressure equipment will be met,

• — the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment pertaining to the pressure equipment type covered, particularly with regard to materials in accordance with point 4 of Annex I,

• — the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

• — the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

• — the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,

• — the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.

• 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

• It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

• The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

• The manufacturer or his authorised representative shall be notified of the decision.

• The notification shall contain the conclusions of the audit and the reasoned assessment decision.

• 3.4.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.

• 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

• The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary.

• It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

• 3.6.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

• Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

• 1. Design examination

• 4.1.The manufacturer shall lodge an application for examination of the design of each item of pressure equipment not covered by a previous design examination with the notified body referred to in point 3.1.

• 4.2.The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, and to assess the conformity with the requirements of this Directive that apply to it. It shall include:

• — the name and address of the manufacturer,

• — a written declaration that the same application has not been lodged with any other notified body,

• — the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements: — a general description of the pressure equipment, — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., — descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment, — a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive, where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, — results of design calculations made, examinations carried out, etc., and — test reports,

• — the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.

• 4.3.The notified body shall examine the application, and where the design meets the requirements of this Directive that apply to the pressure equipment it shall issue an EU design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached.

• The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable.

• Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

• 4.4.The notified body shall keep itself apprised 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 this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

• The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EU design examination certificate — in the form of an addition to the original EU design examination certificate.

• 4.5.Each notified body shall inform its notifying authorities of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

• Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.

• The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

• The notified body shall keep a copy of the EU design examination 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.

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

• 1. Surveillance under the responsibility of the notified body

• 5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

• 5.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

• — the quality system documentation,

• — the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

• — the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

• 5.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

• 5.4. In addition, the notified body may pay unexpected visits to the manufacturer.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

• — the category of the equipment,

• — the results of previous surveillance visits,

• — the need to follow up corrective action(s),

• — special conditions linked to the approval of the system, where applicable,

• — significant changes in manufacturing organisation, policy or techniques.

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

• 5.5. Special surveillance of the final assessment

Final assessment as referred to in section 3.2 of Annex I is subject to increased surveillance in the form of unexpected visits by the notified body. In the course of such visits, the notified body shall conduct examinations on the pressure equipment.

It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

• 1. CE marking and EU declaration of conformity

• 6.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.

• 6.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up and shall mention the number of the design examination certificate.

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

• 1. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

• — the documentation concerning the quality system referred to in point 3.1,

• — the change referred to in point 3.5, as approved,

• — the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.

• 1. Authorised representative

The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.

ANNEX IV

EU DECLARATION OF CONFORMITY (No XXXX)

([^E0014])

• 1.Pressure equipment or assembly (product, type, batch or serial number):

• 2.Name and address of the manufacturer and, where applicable, his authorised representative:

• 3.This declaration of conformity is issued under the sole responsibility of the manufacturer.

• 4.Object of the declaration (identification of pressure equipment or assembly allowing traceability; it may, where necessary for the identification of the pressure equipment or assembly, include an image):

• — description of the pressure equipment or assembly,

• — conformity assessment procedure followed,

• — in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed,

• 5.The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

• 6.References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

• 7.Where appropriate, the name, address and number of the notified body which carried out the conformity assessment and the number of the certificate issued, and a reference to the EU-type examination certificate – production type, EU-type examination certificate – design type, EU design examination certificate or certificate of conformity.

• 8.Additional information:

• Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

(where appropriate, particulars of the signatory authorised to sign the legally binding declaration for the manufacturer or his authorised representative)

ANNEX V

PART A

Repealed Directive with list of the successive amendments thereto

(referred to in Article 50)

Directive 97/23/EC of the European Parliament and of the Council (OJ L 181, 9.7.1997, p. 1).
Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).	Only point 13 of Annex I
Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).	Only point (f) of Article 26(1)

PART B

Time-limit for transposition into national law and date of application

(referred to in Article 49)

Directive	Time-limit for transposition	Date of application
97/23/EC	29 May 1999	29 November 1999 [^E0015]

In accordance with Article 20(3) of Directive 97/23/EC, Member States shall permit the putting into service of pressure equipment and assemblies which comply with the regulations in force in their territory at the date of application of the Directive beyond that date.

ANNEX VI

CORRELATION TABLE

Directive 97/23/EC	This Directive
Article 1(1)	Article 1(1)
Article 1(2)	Article 2(1) to (14)
Article 1(3)	Article 1(2)
—	Article 2(15) to (32)
Article 2	Article 3
Article 3	Article 4
Article 4(1)	Article 5(1)
Article 4(2)	Article 5(3)
—	Article 6
—	Article 7
—	Article 8
—	Article 9
—	Article 10
—	Article 11
Article 5	—
Article 6	—
—	Article 12(1)
Article 7(1)	Article 45
Article 7(2)	Article 44(1)
Article 7(3)	—
Article 7(4)	Article 44(5), second subparagraph
Article 8	—
Article 9(1)	Article 13(1), introductory sentence
Article 9(2) point 1	—
—	Article 13(1)(a)
Article 9(2) point 2	Article 13(1)(b)
Article 9(3)	Article 13(2)
Article 10	Article 14
Article 11(1)	Article 15(1)
Article 11(2)	Article 15(2)
Article 11(3)	Article 15(3)
Article 11(4)	Article 12(2)
—	Article 15(4)
Article 11(5)	Article 15(5)
—	Article 15(6)
Article 12	—
Article 13	—
Article 14(1)	Article 16(1)
Article 14(2)	Article 5(2)
Article 14(3) to (8)	Article 16(2) to (7)
Article 14(9) and (10)	—
—	Article 17
—	Article 18
Article 15(1)	—
Article 15(2)	Article 19(1)
Article 15(3)	Article 19(2)
Article 15(4) and (5)	—
—	Article 19(3) to (6)
—	Article 20
—	Article 21
—	Article 22
—	Article 23
—	Article 24
—	Article 25
—	Article 26
—	Article 27
—	Article 28
—	Article 29
—	Article 30
—	Article 31
—	Article 32
—	Article 33
—	Article 34
—	Article 35
—	Article 36
—	Article 37
—	Article 38
Article 16	—
Article 17	—
Article 18	—
—	Article 39
—	Article 40
—	Article 41
—	Article 42
—	Article 43
—	Article 44(2) to (4)
—	Article 44(5), first subparagraph
—	Article 46
—	Article 47
Article 19	—
Article 20(1) to (2)	—
Article 20(3)	Article 48(1)
—	Article 48(2) and (3)
—	Article 49
—	Article 50
—	Article 51
Article 21	Article 52
Annex I	Annex I
Annex II	Annex II
Annex III, introductory wording	Annex III, introductory wording
Annex III, Module A	Annex III, point 1, Module A
Annex III, Module A1	Annex III, point 2, Module A2
Annex III, Module B	Annex III, point 3.1, Module B, EU-type examination – production type
Annex III, Module B1	Annex III, point 3.2, Module B, EU-type examination – design type
Annex III, Module C1	Annex III, point 4, Module C2
Annex III, Module D	Annex III, point 5, Module D
Annex III, Module D1	Annex III, point 6, Module D1
Annex III, Module E	Annex III, point 7, Module E
Annex III, Module E1	Annex III, point 8, Module E1
Annex III, Module F	Annex III, point 9, Module F
Annex III, Module G	Annex III, point 10, Module G
Annex III, Module H	Annex III, point 11, Module H
Annex III, Module H1	Annex III, point 12, Module H1
Annex IV	—
Annex V	—
Annex VI	—
Annex VII	Annex IV
—	Annex V
—	Annex VI

[^E0001]: Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).

[^E0002]: Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40).

[^E0003]: Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p. 1).

[^E0004]: Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).

[^E0005]: Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).

[^E0006]: Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).

[^E0007]: Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).

[^E0008]: Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).

[^E0009]: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).

[^E0010]: Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (OJ L 330, 16.12.2009, p. 10).

[^E0011]: Directive 2014/34/EU of the European Parliament and the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).

[^E0012]: Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).

[^E0013]: Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

[^E0014]: It is optional for the manufacturer to assign a number to the declaration of conformity.