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Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (Text with EEA relevance)
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The mark of conformity must take the following form:
If the wheel mark is reduced or enlarged the proportions given in the graduated drawing must be respected.
The various components of the wheel mark must have substantially the same vertical dimension, which may not be less than 5 mm.
That minimum dimension may be waived for small devices.
examination of a specimen, representative of the production envisaged, of the complete product (production type);
assessment of the adequacy of the technical design of the marine equipment through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type).
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation. The technical documentation shall make it possible to assess the conformity of the marine equipment with the applicable requirements of the international instruments as referred to in Article 4, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the marine equipment. The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the marine equipment;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation of the marine equipment;
a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with this Directive, together with a description of the solutions adopted to meet those requirements;
results of design calculations made, examinations carried out, etc.; and
test reports;
the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme;
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under its responsibility.
For the marine equipment:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the marine equipment;
For the specimen(s):
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant requirements and testing standards, as well as the elements which have been designed without applying the relevant provisions of those standards;
carry out appropriate examinations and tests, or have them carried out, in accordance with this Directive;
agree with the manufacturer on a location where the examinations and tests will be carried out.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of the international instruments, the notified body shall refuse to issue an EC type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EC type-examination certificate of all modifications to the approved type that may affect the conformity of the marine equipment with the requirements of the relevant international instruments or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EC type-examination certificate.
Each notified body shall inform the other notified bodies concerning the EC type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning 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 EC 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 EC type-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.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
all relevant information for the marine equipment category envisaged;
the documentation concerning the quality system;
the technical documentation of the approved type and a copy of the EC type-examination certificate.
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. The 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 product quality;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
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, qualification reports on the personnel concerned, etc.; and
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant marine equipment field and marine equipment technology concerned, and knowledge of the applicable requirements of the international instruments. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in the fifth indent of point 3.1 in order to verify the manufacturer’s ability to identify the relevant requirements of the international instruments and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
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.
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
the documentation 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, 4.3 and 4.4.
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
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.
The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
all relevant information for the marine equipment category envisaged;
the documentation concerning the quality system; and
the technical documentation of the approved type and a copy of the EC type-examination certificate.
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. The 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 product quality;
the examinations and tests that will be carried out after manufacture;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
the means of monitoring the effective operation of the quality system.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant marine equipment field and marine equipment technology concerned, and knowledge of the applicable requirements of the international instruments. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in the fifth indent of point 3.1, in order to verify the manufacturer’s ability to identify the relevant requirements of the international instruments and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
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.
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
the documentation 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, 4.3 and 4.4.
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.
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.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EC type-examination certificate and with the requirements of the international instruments that apply to them.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EC type-examination certificate and with the appropriate requirements of the international instruments.
The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every product as specified in point 4 or by examination and testing of the products on a statistical basis as specified in point 5.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
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 each approved product or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 2 and 5.1.
The manufacturer shall draw up 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 product’s conformity 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 shall cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the product;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;
a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with this Directive, together with a description of the solutions adopted to meet those requirements;
results of design calculations made, examinations carried out; and
test reports.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the international instruments.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in accordance with this Directive, in order to check the conformity of the product with the applicable requirements of the international instruments.
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 product, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Editorial Information
personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of those procedures and the possibility of reproducing them. It shall have in place appropriate policies and procedures that distinguish between tasks that it carries out as a notified body and other activities;
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the marine equipment technology in question and the mass or serial nature of the production process.
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the applicable requirements and testing standards and of the relevant provisions of Union legislation on harmonisation and of the regulations implementing that legislation;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
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