art_22__para_4

4. The manufacturer shall ensure that procedures are in place to ensure that products fulfil their declared performance and remain in conformity with this Regulation. Product design, including 3-D datasets, production processes and material used shall be appropriate. Where the product is manufactured in series production, the manufacturer shall ensure that procedures are in place to ensure that it maintains its declared performance and remains in conformity with this Regulation. Changes in the product design, including 3-D datasets, production process and material used shall be appropriate. Changes in the applicable harmonised technical specifications shall be adequately taken into account and, where the performance or conformity of the product is affected, shall trigger a re-assessment in accordance with the relevant assessment procedure. The manufacturer shall, where deemed appropriate with regard to ensuring the accuracy, reliability and stability of the declared performance and of the conformity of a product, carry out sample testing of products placed or made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep importers and distributors informed thereof.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.