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5. Statistical verification of conformity

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. 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. 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. 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.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.