sec_5_1_5__para__6

The manufacturer undertaking the module (243) that is used together with module B does not need to be the same person as the one having the EU-type examination certificate under module B. Yet, that manufacturer placing then the product on the market, takes the entire responsibility for the conformity assessment (design & production) of the product. Consequently, he must be in possession of both certificates, although the EU-type examination certificate does not have to be in his name, and the full history of the product. It must be ensured in any case, that the certificate can be allocated to the product that is placed on the market without any doubt. He must have all the administrative and technical information and data, have the information on the type testing performed, manage the technical documentation related to the type testing and have batch testing performed. The above reasoning applies actually to all modules and procedures, independently of whether it is a one-phase or two-phase conformity assessment procedure. In cases where a manufacturer relies on one or more other manufacturer(s) for the design and production of the product there has to be proof that the manufacturer is fully informed about any changes in the design, production and conformity assessment of the product.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.