Article 22

1. When placing a product on the market, the manufacturer shall determine the product type, respecting the boundaries set up therefor by the definition provided in Article 3, point (27). The manufacturer shall ensure that the product’s performance is assessed in relation to both mandatory essential characteristics and those essential characteristics intended to be declared. If the product is covered by product requirements established by delegated acts referred to in Article 7(1), the manufacturer shall ensure that the product has also been designed and constructed in accordance with those requirements. A natural or legal person that manufactures a product using 3-D printing shall satisfy the obligations incumbent on manufacturers when placing it on the market. The obligations shall include, but are not limited to, the use of appropriate 3-D datasets, the use of materials compliant with the applicable procedures under this Regulation, and the verification of the compatibility of 3-D datasets, printing material and the printing technology used. 2. Where a product’s compliance with applicable requirements and its performance in relation to essential characteristics referred to in paragraph 1 of this Article have been demonstrated in accordance with the applicable assessment and verification system or systems set out in Annex IX, the manufacturer shall draw up a declaration of performance and conformity in accordance with Articles 13 to 15, affix the CE marking in accordance with Articles 17 and 18 and, when applicable, ensure the availability of spare parts not commonly available in the market, as referred to in paragraph 8 of this Article, and affix the labelling pursuant to paragraph 9 of this Article. 3. The manufacturer shall, as the basis for the declaration of performance and conformity, draw up a technical documentation in which he shall indicate: the declared use, which shall fall within the scope of the applicable intended use; all the relevant elements necessary to demonstrate performance and conformity; information on the procedures in place referred to in paragraph 4 of this Article; information on the applicable system or systems set out in Annex IX; where relevant, information on the application of simplified procedures applied in accordance with Articles 59 to 61; and the calculation of the performance of environmental sustainability in respect of essential characteristics as referred to in Article 15(2). 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. 5. The manufacturer shall ensure that its products bear a manufacturer-specific unique identification code of the product type and, where available, a batch or serial number which is easily visible and legible for users. Where that is not possible on account of the nature of the product, the required information shall be provided on an affixed label, on the packaging or, where that is also not possible, in a document accompanying the product. The manufacturer shall, in the same way as set out in the first subparagraph, label a product as ‘Only for professional use’ if expertise is needed in order to use it and shall display the label to customers before they are bound by a sales contract, including in the case of distance selling. Products not labelled ‘Only for professional use’ shall be deemed to also be intended for non-professional users and consumers within the meaning of this Regulation and of Regulation (EU) 2023/988. The manufacturer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation. 6. When making a product available on the market, the manufacturer shall ensure that it is accompanied by general product information, instructions for use and safety information, as set out in Annex IV in a language to be determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users. 7. By 18 months after the entry into force of the delegated act referred to in Article 75(1) the manufacturer shall make available a digital product passport referred to in Article 76, through the construction digital product passport system referred to in Article 75, connected to a data carrier referred to in Article 18(2), point (g). 8. In order to ensure the availability of spare parts not commonly available on the market, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by imposing in respect of certain product families and product categories an obligation on manufacturers to make available on the market specific spare parts not commonly available for the products they place on the market. The obligation established by the delegated acts referred to in the first subparagraph of this paragraph shall apply for a period of 10 years after the last product of the respective type has been placed on the market, unless the delegated act sets a different period. Manufacturers subject to the obligation laid down in the first paragraph shall offer the spare parts within a reasonably short delivery period, at a reasonable and non-discriminatory price, and shall inform the public thereof. 9. In order to ensure transparency for users and to promote sustainable products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing specific environmental sustainability labelling requirements for particular product families and product categories when the following conditions are fulfilled: the product is typically chosen or purchased by consumers; and the product does not have a significantly different overall environmental performance over its life cycle depending on its installation. The labelling shall be based on the performance of the product, as assessed in accordance with Article 5(1) or Article 6(1), and shall provide consumer-friendly information understandable by non-experts. 10. The delegated acts referred to in paragraph 9 shall determine the way in which the manufacturer is to affix the label, by specifying the following: the content of the label; the layout of the label, taking into account its visibility and legibility; the manner in which the label is to be displayed to customers, including in the case of distance selling; where appropriate, the electronic means to be used for generating labels. 11. A manufacturer who considers or has reason to believe that a product which it has placed on the market does not conform to its declared performance or does not comply with this Regulation shall immediately take the necessary corrective measures to bring that product into conformity or compliance, or, if appropriate, to withdraw or recall it. If the issue is linked to a supplied component or an externally provided service, the manufacturer shall inform the supplier or service provider and the manufacturer’s competent national authority. 12. Where the product presents a risk, the manufacturer shall, without undue delay and at the latest within three working days, inform all the authorised representatives, importers, distributors, fulfilment service providers, and online market places involved in its distribution, as well as the competent national authorities of the Member States in which the manufacturer or, to its knowledge, other economic operators made the product available. The manufacturer shall, to that effect, provide all useful details and, in particular, specify the type of the non-compliance, the frequency of accidents or incidents, and the corrective measures taken or recommended. In the case of risks caused by products which have already reached an end user or consumer who cannot be identified or contacted directly, the manufacturer shall, through the media and other appropriate channels, ensuring the widest possible reach, disseminate information about appropriate measures to eliminate or, if not possible, to reduce the risks. Where there is a serious risk the manufacturer shall withdraw and recall the product at its own cost.

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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.