The New Approach Directives define the conformity assessment system for the characteristics and intended use of each product group. Accordingly, the main responsibility for the CE marking lies with the manufacturer.
To determine which directive or directives are covered by the product, to determine whether the product meets the requirements described in these directives or directives, to determine whether a third party organization (notified body) needs to intervene in the process, to carry out a risk assessment of the product, and to conduct product testing and analysis. or to have it done in an authorized laboratory and finally to prepare and sign the declaration of conformity to the European Union and to place the CE mark on the product in the last step.
The manufacturer is responsible for placing the CE mark on the product and any information and documents that he has put in the technical file, whether he has decided for himself or has received a test and approval from an notified body. In either case, the manufacturer must provide proof of:
Product type tests to determine the characteristics referenced in the information and documents supporting the CE marking
Factory production control to ensure that the manufacturer assures that the features evaluated during the type test are not changed later
This information determines whether an independent and impartial body, called a notified body, will be involved in the process. Depending on the conditions in the Directive, the notified body may be responsible for: type tests, supervision of factory production control and product certification.
In short, CE marking is an indispensable condition for placing the relevant products on the market. The CE marking on the product indicates the conformity of the product with the relevant directives, together with the declaration of conformity of the manufacturer and the certificate of conformity, if necessary.
Verification of the suitability of a product is subject to an assessment involving various tasks. For example, in order to prove the suitability of a product according to the Construction Products Directive, the manufacturer must have an adequate factory control system in order to trust that it can produce in accordance with the relevant technical specifications. In addition, for certain products listed in the relevant technical specification and in addition to a factory control system, an authorized certification body may need to evaluate factory production controls or the products themselves.
In other words, the manufacturer can carry out factory production control, or the production control or the products themselves can be monitored and evaluated by a notified body.
To obtain a CE certificate for their products, manufacturers must take the following steps:
The first step is to define the directives or directives related to the product. It is important to check whether the product is subject to the mandatory CE marking and to determine which directive it is covered by.
The second step is to determine if the product complies with the basic safety requirements of the directives specified.
The third step is the conformity assessment process. The CE marking can only be affixed to the product when the product meets the requirements. In this step, risks are first assessed and, depending on the risks, the manufacturer acts differently from simple conformity assessment to verification by a notified body.
The fourth step is to place the CE mark on the product. When a product complies with the essential safety requirements of the relevant directive, the CE marking may be affixed.
The fifth step is the declaration of conformity. This declaration proves that the product complies with the mandatory safety requirements and is based on the technical file.
The product can now move freely in European Union countries without any other formality, national safety standard or new testing.
Our company also provides CE Certificate services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
CE Certificate services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.