2016. Self-certification Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. Self-certification exists only for products that have a minimal risk for their use, and this is clearly foreseen in the relevant directive and regulation according to the product "category". In order to certify, the manufacturer must do several things: 1. Investigate whether the product needs to have a CE marking. The product must conform to all Directives and Regulations that apply to the product. 2. Choose the conformity assessment procedure from the modules called out by the directive or the regulation for the product according to each category (level of risk) involved. There are several modules available for the Conformity Assessment Procedures, but only a few of them involve self-certification. The most of these procedure require a "type Approval" and a Production conformity assessment by a Notified Body. The common procedures (modules) of certification are as listed below. A product normally needs more than one procedure (Module) to be implemented: Module A – Internal production control. Module B – EC type-examination. Module C – Conformity to type. Module D – Production quality assurance. Module E – Product quality assurance. Module F – Product verification. Module G – Unit verification. Module H – Full quality assurance. Module H1 – Full quality assurance and Design Examination. The level of risk is defined by the "category" of each equipment. The higher the category, the higher the risk. After defining the category, the manufacturer, in order to obtain certification, shall then apply the relevant procedures for the specific category of the product or choose the relevant procedures for a higher-category product. The manufacturer, after insuring that the relevant modules for the product category have been applied, will affix the mark and draw up a Declaration of Conformity. The Declaration of Conformity contains a description of the product, the directive(s) and regulation(s) applied, the product category for each directive or regulation, the module chosen, and the name and registration number of the notified body involved in certification procedures (models). Notified bodies involved in certification procedures are organizations