Conformity assessment procedures
Article 2
1. Where the product is categorised in risk group 1 or 2 under Implementing Decision (EU) 2024/368 or, in the case of a metallic composition, in product group A or B in Table 2 ‘Product group for metallic compositions’ of Annex II to Commission Implementing Decision (EU) 2024/365 ( 4 ) , both of the following conformity assessment procedures shall apply: (a) Module B (EU type examination) as set out in Annex II to Decision No 768/2008/EC of the European Parliament and of the Council ( 5 ) carried out by a notified body with the following specifications: (i) the conformity assessment shall contain an examination of a test piece (production type); (ii) all relevant tests referred to in Implementing Decision (EU) 2024/368 shall be performed by the notified body or on behalf of the notified body; (iii) test pieces for examination shall be withdrawn by the notified body when inspecting the production site pursuant to point (b)(ii) or (iii), except when the production of products has not yet started; (b) Module D (Conformity to type based on quality assurance of the production process) as set out in Annex II to Decision No 768/2008/EC with the following specifications: (i) the quality system shall be assessed by the notified body that has carried out the conformity assessment procedure referred to in point (a); (ii) an initial inspection of the production site to assess the quality system and to withdraw test pieces for type examination shall be carried out by the notified body; (iii) an annual inspection of the production site to assess the quality system and to withdraw test pieces for the re-assessment of the type examination pursuant to point (a) or for a reduced testing pursuant to point (iv) of this point shall be carried out by the notified body; (iv) annual reduced testing may be performed by the notified body or on behalf of the notified body, and tests may be carried out by the manufacturer as part of the quality system. Where the conformity assessment procedures referred to in the first subparagraph demonstrate that the product complies with the minimum hygiene requirements, the notified body shall issue a certificate for both conformity assessment procedures referred to in points (a) and (b) of that subparagraph to the manufacturer, the importer or the authorised representative. The certificate shall contain the name and address of the manufacturer, the conclusions of the conformity assessment, any conditions for the certificate and the necessary data for identification of the approved type. The certificate shall have a validity of 5 years. Based on the outcome of the annual inspection referred to in the first subparagraph, point (b)(iii), the notified body may withdraw the relevant certificates. 2. Where the product is categorised in risk group 3 or 4 under Implementing Decision (EU) 2024/368 or, in the case of a metallic composition, in product group C or D in Table 2 ‘Product group for metallic compositions’ of Annex II to Implementing Decision (EU) 2024/365, both of the following conformity assessment procedures shall apply: (a) Module B (EU type examination) as set out in Annex II to Decision No 768/2008/EC carried out by a notified body and with the following specifications: (i) the conformity assessment shall contain an examination of a test piece (production type); (ii) all relevant tests referred to in Implementing Decision (EU) 2024/368 shall be performed by the notified body or on behalf of the notified body; (iii) test pieces shall be supplied by the manufacturer, the importer or the authorised representative to the notified body for examination; (b) Module C (Conformity to type based on internal production control) as set out in Annex II to Decision No 768/2008/EC. Where the conformity assessment procedures referred to in the first subparagraph demonstrate that the product complies with the minimum hygiene requirements, the notified body shall issue a certificate for the conformity assessment procedure referred to in that subparagraph, point (a), to the manufacturer, the importer or the authorised representative. The certificate shall contain the name and address of the manufacturer, the conclusions of the conformity assessment, any conditions for the validity of the certificate and the necessary data for the identification of the approved type. The certificate shall have a validity of 5 years. The manufacturer shall ensure and declare that the product concerned is in conformity with the type described in the EU type examination certificate and satisfies the requirements set out in this Regulation. 3. Where the product is an assembled product, the applicable conformity assessment procedure shall be determined by the individual component with the highest risk group categorisation (RG1 is the highest risk group, RG4 is the lowest risk group) under Implementing Decision (EU) 2024/368 or, in the case of metallic compositions, the highest categorised product group in Table 2 ‘Product group for metallic compositions’ of Annex II to Implementing Decision (EU) 2024/365. 4. The applicable conformity assessment procedure for the manufacture of an individual component of an assembled product shall be determined by the risk group of that individual component under Implementing Decision (EU) 2024/368 or, in the case of metallic compositions, the product group of the individual component in Table 2 ‘Product group for metallic compositions’ of Annex II to Implementing Decision (EU) 2024/365. 5. Where compliance of a product with the applicable minimum hygiene requirements has been demonstrated by the conformity assessment procedure referred to in paragraph 1 or 2, manufacturers, or their authorised representatives, shall draw up an EU declaration of conformity. By drawing up the EU declaration of conformity, or by having it drawn up by its authorised representative, the manufacturer, assumes responsibility for the compliance of the product with the minimum hygiene requirements. The EU declaration of conformity shall have the model structure set out in the Annex and shall be continuously updated. It shall be translated by the manufacturer, or its authorised representative, into the language or languages required by the Member State in which the product is placed on the market.