If manufacturers wish to market their products in European Union countries without any problems, they must comply with the CE Mark application principles for the products and product groups covered by the New Approach Directives. One of the most important steps of CE Marking is the declaration of conformity which must be prepared by the manufacturer.
A declaration of conformity is a document required to accompany a product. In preparing this document, the following must be considered by the manufacturer or its authorized representative in the European Union:
The product must comply with all relevant requirements of the relevant directives.
The name and address of the manufacturer and information about the product, such as product brand and serial number, must be included in the document.
The document must be signed by the manufacturer or its authorized representative and the duty of the signatory must be explained.
There are also sanctions in the relevant directives regarding the CE Mark application. In order to prevent abuse of the CE Mark and to keep product safety to the highest standards, there are many organizations in the European Union that apply the CE Mark legal regulations. Execution and market surveillance are conducted by public authorities in the countries of the Arupa Union (usually by the Market Surveillance Institutions) and each state evaluates irregularities within the framework of national law.
Market surveillance processes are carried out differently depending on which directives apply to the products. In the UK, for example, the organizations responsible for CE Marking are: Trade Standards Services, Health and Safety Management, Medicines and Health Products Regulatory Authority, the Vehicle Certification Agency and the National Measurement Office.
In any European Union country, if it is determined by an official body responsible for inspections that the product does not comply with the CE Mark application requirements, the firm is allowed to make the necessary improvements first. If this is not observed, the products are collected from the market and may be fined or imprisoned, depending on the extent of the violation.
In this respect, it is not only necessary to comply with the CE Mark application processes, but also to keep certain documents after the CE Mark is placed on the product. This information may be requested at any time by the authorities to check that the CE Mark is legally affixed to a product.
The information to be stored may be different depending on specific directives related to the product. The following are general documents that should be kept:
Documentation describing how the product is manufactured
Documents explaining how the product complies with the relevant national standards
Addresses of production and storage locations
Documentation for product design and production
Documents explaining which New Approach Directives apply to the product and how they are met
European Union type examination certificates, if any
All these documents should be kept together in a technical file.
In the application of CE Mark, it is useful to get help from the authorized institutions in order to fully implement the requirements of the relevant directives, to carry out tests and analyzes where necessary, to determine the conformity with the relevant standards and to support the preparation of technical saturation. Certification bodies direct the application of comprehensive CE Marking in accordance with the directive principles of the product. In this context, product grouping is performed to determine the relevant requirements, product conformity tests are conducted based on harmonized standards of the European Union, technical file is prepared, user instructions are written and checked, European Union conformity declaration is verified and products are supervised with CE Marking.
Our company also provides CE Marking 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 Marking 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.