Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilization where necessary, together with all the routine, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, conformity of the products with the type described in the EC type-examination certificate and with the requirements of this Directive which apply to them.
Pred začetkom proizvodnje mora proizvajalec pripraviti dokumente z razlago proizvodnega procesa, zlasti kar zadeva sterilizacijo, kjer je ta potrebna, skupaj z vsemi rutinskimi, vnaprej določenimi določbami, ki se morajo uveljavljati za zagotovitev homogene proizvodnje in, kjer je to primerno, skladnosti izdelkov s tipom, opisanim v potrdilu o ES tipskem preskusu, in z vsemi zahtevami te direktive, ki veljajo zanje.