ANNEX VSupplementary provisions
ANNEX V CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE F: CONFORMITY TO TYPE BASED ON SUBSYSTEM OR SAFETY COMPONENT VERIFICATION 1. Conformity to type based on subsystem or safety component verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on his sole responsibility that the subsystems or safety components concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystems or safety components with the approved type described in the EU-type examination certificate and with the requirements of this Regulation that apply to them. 3. Verification 3.1. The manufacturer shall lodge an application for subsystem or safety component verification with the notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) all relevant information for the subsystems or safety components approved under module B; (d) the technical documentation of the approved type and a copy of the EU-type examination certificate(s); (e) details of the premises where the subsystem or the safety component can be examined. 3.2. The notified body shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the subsystems or safety components with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation. The examinations and tests to check the conformity of the subsystems or safety components with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every subsystem or safety component as specified in point 4 or by examination and testing of the subsystems or safety components on a statistical basis as specified in point 5. 4. Verification of conformity by examination and testing of every subsystem or safety component 4.1. All subsystems or safety components shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. 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 to each approved subsystem or safety component or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 30 years after the subsystem or safety component has been placed on the market. 5. Statistical verification of conformity 5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his subsystem or safety component for verification in the form of homogeneous lots. 5.2. A random sample shall be taken from each lot. All the subsystems or safety components in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. 5.3. If a lot is accepted, all the subsystems or safety components of the lot shall be considered approved, except for those subsystems or safety components from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved subsystem or safety component or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. 5.4. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent the placing on the market of that lot. In the event of the frequent rejection of lots, the notified body may suspend the statistical verification and take appropriate measures. 6. 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, the latter's identification number to each individual subsystem or safety component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation. 6.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up. 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 subsystems or safety components. 7. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the subsystems or safety components during the manufacturing process. 8. 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 obligations set out in points 2 and 5.1.