Replacement of type-testing and type-calculation
1. A manufacturer may replace type-testing or type-calculation with a specific section in the technical documentation referred to in Article 22(3) demonstrating that:
(a)
for one or several essential characteristics of the product, which the manufacturer places on the market, that product is deemed to achieve a certain level or class of performance without testing or calculation, or without further testing or calculation, in accordance with the conditions set out in the delegated acts referred to in Article 5(6); or
(b)
the product, covered by a harmonised technical specification or a European assessment document, which the manufacturer places on the market is a system made of components, which the manufacturer duly assembles following precise instructions, including compatibility criteria in the case of individual components, given by the provider of such a system or of a component thereof, who has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised technical specification or European assessment document. When these conditions are satisfied and when the manufacturer has notably verified that the precise compatibility criteria of the provider are met, the manufacturer is entitled to declare performance corresponding to all or part of the test results provided to it for the system or the component;
(c)
the product, covered by a harmonised technical specification or by a European technical assessment, which the manufacturer places on the market, corresponds to a product-type of a product manufactured by another manufacturer and is already subject to type-testing or type-calculation.
When the conditions in point (c) are satisfied, the manufacturer may declare the performance corresponding to all or part of the results of this other product. The manufacturer shall only apply this simplification after having obtained an authorisation of the other manufacturer, who remains responsible for the accuracy, reliability and stability of those test results.
2. If the assessment and verification system applicable includes a performance assessment by a notified body as set out in Annex IX, a notified body or TAB shall, in place of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
Use of simplified procedures by micro-enterprises
1. A micro-enterprise may replace type-testing or type-calculation for an essential characteristic under assessment and verification system 3 set out in point 5 of Annex IX with a specific section in the technical documentation referred to in Article 22(3) providing data equivalent to the assessment required for this essential characteristic in accordance with the applicable harmonised technical specifications or European assessment document.
2. A notified body or TAB shall, instead of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
Custom-made non-series products
1. As an alternative to the exemption in Article 14, point (a), a manufacturer of a product that fulfils the conditions in Article 14, point (a), may replace the performance assessment of the product with a specific section in the technical documentation referred to in Article 22(3) demonstrating the compliance of that product with the applicable requirements and providing data equivalent to the data required by this Regulation and the applicable harmonised technical specifications or European assessment document.
2. If the assessment and verification system applicable includes a performance assessment by a notified body as set out in Annex IX, a notified body or TAB shall, in place of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
Recognition of assessment and verification by another notified body
1. When a notified body is to assess and verify a certain product in accordance with Annex IX, it may refrain from the assessment and verification and recognise the assessment and verification undertaken by another notified body for the same economic operator where all of the following conditions apply:
(a)
the product has been correctly assessed and verified by the other notified body;
(b)
the assessed or verified economic operator agrees to share all relevant data and documents with the recognising notified body; and
(c)
the validity of the certificate is limited to the validity of the certificate issued by the other notified body.
This paragraph shall also apply to validation reports and to assessments of calculation of the environmental sustainability undertaken under Regulation (EU) 2024/1781.
2. When a notified body is to assess and verify a certain product in accordance with Annex IX, it may refrain from the assessment and verification of its parts or materials and recognise the results of the assessment and verification by another notified body, if the provider of those parts or materials applied the required assessment and verification system to them and there is an agreement between the manufacturer of the product and the provider that ensures the free flow of all information between them and the notified bodies in view of ensuring compliance with this Regulation.
This paragraph shall also apply to assessments of the calculation of the environmental sustainability undertaken under Regulation (EU) 2024/1781.
