ANNEX IVU.K.EC VERIFICATION
2.The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and to the requirements of the Directive which apply to them. 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. The manufacturer must affix the CE marking in accordance with Article 17 and draw up a declaration of conformity.U.K.
In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and 4.