The supplier changed a component without telling us

Conformity is shown for a product as designed and documented. When a supplier swaps a part, the evidence may no longer describe what ships. The General Product Safety Regulation (EU) 2023/988 requires manufacturers to keep the technical documentation up to date (Article 9(3)) and to have procedures in place so that products produced in series remain in conformity with the general safety requirement (Article 9(4)). The safety assessment takes into account, among other things, the product's design, technical features and composition (Article 6(1)(a)).^[1]

The CE acts say it more directly. Under the Low Voltage Directive 2014/35/EU, manufacturers must ensure that procedures are in place for series production to remain in conformity, and changes in product design or characteristics must be adequately taken into account (Article 6(4)). The EU declaration of conformity must be continuously updated (Article 15(2)). Where a notified body has examined the type, the manufacturer must inform it of all modifications to the approved type that may affect conformity or the conditions for validity of the certificate, and such modifications require additional approval (Decision No 768/2008/EC, Annex II, Module B, point 7). For products under Union harmonisation legislation, Chapter III, Section 1 of the GPSR does not apply (Article 2(1), third subparagraph, point (b)); the sector act carries these duties.^[2][3]

The importer cannot ignore what it sees. Under the GPSR, an importer that has reason to believe, on the information in its possession, that a product does not conform may not place it on the market until it has been brought into conformity, and where the product is dangerous it informs the manufacturer and ensures the authorities are informed through the Safety Business Gateway even before placing (Article 11(2)). Where a product it has already placed is dangerous, it must inform the manufacturer, ensure corrective measures including withdrawal or recall, inform consumers and notify the authorities through the Safety Business Gateway (Article 11(8)). The Low Voltage Directive sets the same pattern for importers of electrical equipment (Article 8(2) and (7)).^[1][2]

Traceability is the other half. On request, economic operators identify any operator that supplied them with the product or with a part or component of it, and must be able to present that information for six years (GPSR Article 15(3) and (5)). Knowing which batch used which component is what keeps a corrective action narrow.^[1]