anx_IX__table

| 7. | The following horizontal rules pertaining to some or all of the systems above shall apply: (a) When a system includes an inspection of the manufacturing plant by a notified body, those inspections shall cover all locations at which significant manufacturing processes take place and shall at least include verification of the following elements: (i) the factory production control specifying the measures and frequencies foreseen to ensure constancy of performance, including the critical to performance parameters; (ii) an outline of the intended factory production control. (b) When a system includes factory production control, those controls shall cover the production process from the moment when the raw materials and components were received to the dispatch of the product (‘gate to gate’ approach) once that production has started, and shall at least include the following elements: (i) ensuring that the products conform to the product type and therefore attain the performance declared in the declaration of performance and conformity, and are compliant with the requirements set out in or adopted in accordance with this Regulation; (ii) application of the technical details necessary for the implementation of the assessment and verification system or systems, as defined in harmonised technical specifications, European assessment documents and voluntary harmonised standards, including, as a minimum, those parameters that are critical to performance. (c) When a system includes further testing of samples, the following shall apply: (i) tests shall include testing of an adequate number of products, as defined in harmonised technical specifications, European assessment documents and voluntary harmonised standards, with regard to conformity with the product type; (ii) where tests are not suitable for the product, the product type may be defined using the applicable extended application rules referred in harmonised technical specifications, European assessment documents and voluntary harmonised standards, where available, and notified bodies confirming that the product type was correctly determined shall also confirm that the relevant extended application rules were correctly applied; (iii) results from tests undertaken by another manufacturer or notified body may be used in accordance with Articles 59 and 62. (d) In the case of systems dealing with environmental sustainability, the validation shall consist of the validation of calculations and input data, in which context the notified body shall validate whether the modelling and input data applicable in accordance with the harmonised technical specification or European assessment document reflect the performance of the product, as well as the use of the software provided by the Commission, along with any data used, and in particular shall validate the reliability of any company-specific data used. (e) Notified bodies and manufacturers shall consider the European technical assessment issued for the product as the assessment of the performance of that product. Manufacturers finding evidence or informed by the notified body that the performance of the product is not in conformity with the European technical assessment shall bring that product into conformity with that assessment, including, when relevant, by fulfilling of obligations set out in Article 22(11).

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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.