5.1.5 一モジュール及び二モジュールの手続 – 型式に基づく手続（EU型式審査）

In some cases e.g. mass production based on a type/specimen ‘representative of the production envisaged’ and where the product in question is of complex design, the EU legislation may lay down the conformity assessment procedure in two steps:

—first the examination of conformity of the type/specimen against the relevant legal requirements (so called EU-Type examination - module B);

—and then the determination of the conformity of the manufactured products against the approved EU-type.

In these cases conformity assessment procedures are composed of two modules; the first module is always module B.

This method not only reduces burden and costs but is also more efficient compared to a traditional examination of the conformity products directly against the legal requirements. Once the type is approved (and this is done only once for a specific specimen), it must be checked only whether the products to be placed on the market are in conformity with the approved type.

The conformity assessment body involved under module B is not necessarily the same as the one involved in the module that is used together with module B. The date of issue of the certificate of the module issued together with module B must always be later as the date of the module B certificate. Both certificates must be available before the first placing of the product on the market.

In cases where there is no EU-type examination, conformity assessment procedures are composed of one two-phase (design & production) module.

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.

It is necessary that the certificate demonstrate that the appropriate module has been carried out in its entirety for the specific product it refers to.