- Latest available (Revised)
- Point in Time (14/08/2014)
- Original (As adopted by EU)
Council Directive 96/98/EC of 20 December 1996 on marine equipment (repealed)
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Version Superseded: 17/09/2016
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The application must include:
the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,
a written declaration that the same application has not been lodged simultaneously with any other notified body,
the technical documentation as described in point 3.
The applicant must place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called ‘type’(1). The notified body may request further specimens if needed for the test programme.
A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.
If a manufacturer is refused a type-certification, the notified body must give detailed reasons for that refusal.
Where a manufacturer reapplies for type-approval for equipment for which a type-certificate has been refused, his submission to the notified body must include all relevant documentation, including the original test reports, the detailed reasons for the previous refusal and details of all modifications made to the equipment.
The application must include:
all relevant information for the product 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 must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality-system documentation must permit a consistent interpretation of the quality programmes, plan, manuals and records.
It must, in particular, include an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
the 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 of the personnel concerned, etc.,
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
The auditing team must have at least one member with experience of assessment in the product technology concerned. The assessment procedure must include a visit to the manufacturer's premises.
The manufacturer must be notified of the decision. The notification must include the conclusions of the examination and the reasoned assessment decision.
The manufacturer or his authorized representative established within the Community must keep the notified body that has approved the quality system informed of any intended updating of that quality system.
The notified body must assess the modifications proposed and decide whether the modified quality system will still satisfy the requirements laid down in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decision. The notification must include 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 of the personnel concerned, etc.
the documentation referred to in the second indent of the second paragraph of point 3.1,
the updating referred to in the second paragraph of point 3.4,
the decision and reports from the notified body referred to in the final paragraph of point 3.4, point 4.3 and point 4.4.
The application must include:
all relevant information for the product category envisaged,
documentation concerning the quality system,
the technical documentation of the approved type and a copy of the EC type-examination certificate.
It must, in particular, include an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
the examinations and tests that will be carried out after manufacture,
the means of monitoring the effective operation of the quality system,
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
The auditing team must have at least one member with experience as an assessor in the product technology concerned. The assessment procedure must include an assessment visit to the manufacturer's premises.
The manufacturer must be notified of the decision. The notification must include the conclusions of the examination and the reasoned assessment decision.
The manufacturer or his authorized representative established within the Community must keep the notified body that has approved the quality system informed of any intended updating of that quality system.
The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements laid down in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decisions. The notification must include the conclusions of the examination and the reasoned assessment decision.
the quality-system documentation,
the technical documentation,
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
the documentation referred to in the third indent of the second paragraph of point 3.1,
the updating referred to in the second paragraph of point 3.4,
the decision and reports from the notified body referred to in the final paragraph of point 3.4, point 4.3 and point 4.4.
If a lot is rejected, the notified body or the competent authority must take appropriate measures to prevent that lot's being put on the market. In the event of frequent rejection of lots the notified body may suspend statistical verification.
The manufacturer may, under the responsibility of the notified body, affix the latter's identification symbol during the manufacturing process.
The notified body must affix its identification number or cause it to be affixed to the approved product and must draw up a certificate of conformity concerning the tests carried out.
The application must include:
all relevant information for the product category envisaged and
documentation concerning the quality system.
All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality-system documentation must ensure common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
It must, in particular, include an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
the technical design specifications, including standards, that will be applied and the assurance that the essential requirements of the international instruments that apply to the products will be met,
the design-control and design-verification techniques, processes and systematic actions that will be used in the design of the products pertaining to the product category covered,
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 of the personnel concerned, etc.,
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
The auditing team must have at least one member with experience as an assessor in the product technology concerned. The assessment procedure must include an assessment visit to the manufacturer's premises.
The manufacturer must be notified of the decision. The notification must include the conclusions of the examination and the reasoned assessment decision.
The manufacturer or his authorized representative established within the Community must keep the notified body that has approved the quality system informed of any intended updating of that quality system.
The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements laid down in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decisions. The notification must include the conclusions of the examination and the reasoned assessment decision.
the quality-system documentation,
the quality records as provided for in the design part of the quality system, such as the results of analyses, calculations, tests, etc.,
the quality records as provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
the documentation referred to in the second indent of the second paragraph of point 3.1,
the updating referred to in the second paragraph of point 3.4,
the decision and reports from the notified body referred to in the final paragraph of point 3.4, point 4.3 and point 4.4.
It must include:
the technical design specifications, including standards, that have been applied and
the necessary supporting evidence for their adequacy, in particular where the standards specified in Article 5 have not been applied in full. Such supporting evidence must include the results of tests carried out by an appropriate laboratory of the manufacturer's or on his behalf.
the EC design-examination certificates and additions issued and
the EC design-approvals and additional approvals withdrawn.
The provisions set down in this Appendix apply to all modules of Annex B.
The technical documentation referred to in Annex B must comprise all relevant data and means used by the manufacturer to ensure that equipment complies with the essential requirements relating to it.
The technical documentation must make it possible to understand the design, manufacture and operation of the product, and must make it possible to assess compliance with the requirements of the relevant international instruments.
The documentation must, so far as they are relevant to assessment, include:
a general description of the type,
conceptual-design, build standard and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes, including the operation of the product,
the results of design calculations made, impartial examinations carried out, etc.,
impartial test reports,
manuals for installation, use and maintenance.
Where appropriate, the design documentation must contain the following:
attestations relating to the equipment incorporated in the appliance,
attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance,
any other document that makes it possible for the notified body to improve its assessment.
A type may cover several versions of the product provided that the differences between the versions do not affect the level of safety or the other requirements concerning the performance of the product.
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