Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance)

• 3.2.The manufacturer shall draw up an EU declaration of conformity for a machinery or related product model and keep it at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market or put into service. The EU declaration of conformity shall identify the machinery or related product 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 point 3 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.

ANNEX IX

CONFORMITY BASED ON FULL QUALITY ASSURANCE

(Module H)

• 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 its sole responsibility that the machinery or related product concerned satisfies the requirements of this Regulation 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 machinery or related products concerned 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 its quality system with the notified body of its choice, for the machinery or related products concerned.

• The application shall include:

• (a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative;

• (b) the technical documentation described in Annex IV, Part A, points (a) to (g), (i) to (k) and (m) to (o) for one model of each category of machinery or related products intended to be manufactured.

• (c) the documentation concerning the quality system; and

• (d) 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 machinery or related products with the requirements of this Regulation that apply to them.

• 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:

• (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;

• (b) the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) will not be applied in full, the means, including other technical specifications, that will be used to ensure that the essential health and safety requirements of this Regulation that apply to the machinery or related product will be met;

• (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the machinery or related product;

• (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

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

• (f) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;

• (g) the means of monitoring the achievement of the required design and product 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 machinery or related product field and technology concerned, and with knowledge of the applicable essential health and safety requirements set out in Annex III. 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(b), to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Annex III and to carry out the necessary examinations with a view to ensuring compliance of the machinery or related product with those requirements.

• The manufacturer or its 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 that body with all necessary information, in particular:

• (a) the quality system documentation;

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

• (c) 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.

• 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.

• 4.4.In addition, the notified body may pay unexpected visits to the manufacturer. 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 required CE marking set out in this Regulation, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product that satisfies the applicable requirements of this Regulation.

• 5.2.The manufacturer shall draw up a written EU declaration of conformity for each machinery or related product model and keep it at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market or put into service. The EU declaration of conformity shall identify the machinery or related product 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 at least 10 years after the machinery or related product has been placed on the market or put into service, keep at the disposal of the national authorities:

• (a) the technical documentation referred to in point 3.1(b);

• (b) the documentation concerning the quality system referred to in point 3.1(c);

• (c) the information relating to the change referred to in point 3.5, as approved;

• (d) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

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

Each notified body shall inform the other notified bodies of quality system approval decisions, which it has refused, suspended or withdrawn, and, upon request, of quality system approval decisions, 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 its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.

ANNEX X

CONFORMITY BASED ON UNIT VERIFICATION

(Module G)

• 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 its sole responsibility that the machinery or related product, which is subject to point 4, is in conformity with the essential health and safety requirements set out in Annex III.

• 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 machinery or related product’s conformity with the relevant essential health and safety requirements set out in Annex III, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable essential health and safety requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the machinery or related product.

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

• (a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative;

• (b) the technical documentation for the unit of machinery or related products intended to be manufactured.

In addition, the technical documentation shall, wherever applicable, contain at least:

• (i) the elements set out in points (a) to (g) of Annex IV, Part A;

• (ii) the documentation concerning the quality system; and

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

• 2.1.The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for at least 10 years after the machinery or related product 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 machinery or related product with the applicable essential health and safety requirements set out in Annex III.

• 1. Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or common specifications, or equivalent tests, to check the conformity of the machinery or related product with the applicable essential health and safety requirements set out in Annex III, or have them carried out. In the absence of such a harmonised standard and/or common specification the notified body concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate in respect of the examinations and tests carried out and shall affix its identification number to the approved machinery or related product, or have it affixed under its responsibility.

The manufacturer shall keep the certificates at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market.

• 1. CE marking and EU declaration of conformity

• 5.1.The manufacturer shall affix the required CE marking set out in Article 10(2) and, under the responsibility of the notified body referred to in point 4, that body’s identification number, to the machinery or related product that satisfies the applicable essential health and safety requirements set out in Annex III.

• 5.2.The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market or put into service. The EU declaration of conformity shall identify the machinery or related product 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 2.1 and 5 may be fulfilled by its authorised representative, acting on its behalf and under its responsibility, provided that those obligations are specified in the mandate.

ANNEX XI

ASSEMBLY INSTRUCTIONS FOR PARTLY COMPLETED MACHINERY

• 1.The assembly instructions for partly completed machinery shall contain a description of the conditions, which are to be met to ensure that the partly completed machinery is correctly incorporated in the machinery or other partly completed machinery or equipment, and that the machinery or other partly completed machinery or equipment with the incorporated partly completed machinery does not compromise the health and safety of persons and, where appropriate, domestic animals and property, and, where applicable, of the environment.

• 2.The assembly instructions shall contain relevant information to be used in the instructions of the machinery or other partly completed machinery or equipment, in which the partly completed machinery is to be assembled. Each assembly instruction shall contain, where applicable, at least the following information:

• (a) a general description of the partly completed machinery;

• (b) the drawings, diagrams, descriptions and explanations necessary for the incorporation into the final machinery, maintenance and repair of the partly completed machinery and for checking its correct functioning;

• (c) warnings concerning the ways in which the partly completed machinery must not be used that experience has shown might occur;

• (d) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the partly completed machinery is to be mounted;

• (e) information regarding noise or vibration which is likely to be reduced by the incorporation;

• (f) information about the essential health and safety requirements set out in Annex III which are applicable to the partly completed machinery;

• (g) the essential characteristics of tools which may be fitted to the partly completed machinery;

• (h) the conditions in which the partly completed machinery meets the requirement of stability, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;

• (i) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the partly completed machinery and of its various parts where these are regularly to be transported separately;

• (j) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;

• (k) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed taking account of the design;

• (l) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;

• (m) the specifications of the spare parts to be used, when these affect the health and safety of operators;

• (n) a clear description of the version of the assembly instructions which corresponds to the partly completed machinery model.

• If the partly completed machinery is intended to be used in machinery covered by Annex III, chapters 2 to 6, the assembly instructions must also contain relevant information to be used in the instructions for use for these machinery.

• 3.The assembly instructions for partly completed machinery shall contain the EU declaration of incorporation, or the internet address or machine readable code where the EU declaration of incorporation can be accessed.

ANNEX XII

CORRELATION TABLE

[^E0001]: Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).

[^E0002]: 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).

[^E0003]: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

[^E0004]: Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

[^E0005]: Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).

[^E0006]: It is optional for the manufacturer to assign a number to the declaration of conformity.

[^E0007]: It is optional to assign a number to the declaration of conformity.

[^E0008]: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1).