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)

7.2.The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type- examination certificate of all modifications to the approved type and of all modifications to the technical documentation that may affect the conformity of the machinery or related product with the applicable essential health and safety requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate. 7.3.The manufacturer shall ensure that the machinery or related product continues to fulfil the applicable essential health and safety requirements in light of the state of the art. 7.4.The manufacturer shall ask the notified body to review the EU type-examination certificate either: In the case referred to in point (c), the review may lead to a renewal of the EU type-examination certificate only when the application is submitted by the manufacturer at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate. Where the manufacturer fails to comply with the deadlines mentioned above, the review may lead only to an approval in the form of an addition to the original EU type-examination certificate and the expiry date of the certificate shall be that of the original certificate. 7.5.The notified body shall examine the machinery or related product type and, where necessary in the light of the changes made, carry out the relevant tests to ensure that the approved type continues to fulfil the applicable essential health and safety requirements. If the notified body is satisfied that the approved type continues to fulfil the applicable essential health and safety requirements, it shall renew the EU type-examination certificate or issue an addition to the original EU type-examination certificate. The notified body shall ensure that the review procedure is finalised before the expiry date of the EU type-examination certificate. 7.6.Where the conditions referred to in points (a) and (b) of point 7.4 are not met, a simplified review procedure shall apply. The manufacturer shall supply the notified body with the following: Where the notified body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out. In that case, the notified body shall renew the EU type-examination certificate. The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure. If the notified body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply. 7.7.If, following the review, the notified body concludes that the EU type-examination certificate is no longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the market of the machinery or related product concerned.

Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto, which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the EU type-examination 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 type-examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.

ANNEX VIII

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

(Module C)

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.

ANNEX IX

CONFORMITY BASED ON FULL QUALITY ASSURANCE

(Module H)

The application shall include: 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: 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.

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: 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.

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.

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.

ANNEX X

CONFORMITY BASED ON UNIT VERIFICATION

(Module G)

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

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.

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.

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