Article 9 › 2

Before placing their products on the market, manufacturers shall carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety. Where appropriate with regard to possible risks related to the product, the technical documentation referred to in the first subparagraph shall also contain, as applicable: (a) an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including the outcome of any reports related to tests conducted by the manufacturer or by another party on their behalf; and (b) the list of any relevant European standards as referred to in Article 7(1), point (a), or the other elements referred to in Article 7(1), point (b) or Article 8, applied to meet the general safety requirement laid down in Article 5. Where any of the European standards, health and safety requirements or elements as referred to in Article 7(1) or Article 8 have been only partly applied, the manufacturers shall identify the parts which have been applied.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26