If manufacturers wish to market their products to the European Union without any problems, they must comply with the CE Mark’s operating standards for the products and product groups covered by New Approach Direcpent. One of the most important steps of CE is marking the declaration of approval that must be prepared by the manufacturer.
A declaration of conformity is a document that is required to comply with a product. In preparing this document, the following must be considered by an authorized manufacturer or representative in the European Union:
- The product must comply with all applicable requirements of the relevant instructions.
- Manufacturer’s name and address and product information, such as product details and serial number, must be included in the document.
- The document must be signed by the manufacturer or its authorized representative and the signatory function must be described.
- There are also sanctions in the relevant guidelines regarding the CE Mark program. In order to prevent the misuse of the CE Mark and to keep the product safety at its highest level, there are many organizations in the European Union that use CE patent laws. Executions and market surveillance are carried out by civil authorities in the countries of the Arupa Union (usually the Market Monitoring Centers) and each country analyzes the non-compliance with the national legal framework.
Market sourcing processes are performed differently depending on which orders apply to the products. In the UK, for example, the organizations responsible for CE Marking are: Commercial Trading Services, Safety Management, Medicines and Healthcare Product Managers, Car Certification Center and Country Rating Office.
In any European Union country, as determined by the official body responsible for testing whether the product does not comply with the requirements of the CE Mark system, the firm is allowed to make the required improvements first. If this is not considered, the products are collected in the market and can be fined or bound, depending on the extent of the violation.
In this regard, it is not only necessary to follow IC application procedures. This information can be requested by the authorities at any time to check that the CE Mark is officially included in the product.
Information to be stored may vary depending on the specific product-related instructions. The following are standard documents to be kept:
- Documents describing how the product is made
- Documents describing how the product complies with relevant national standards
- Production and storage addresses
- Design and product documentation
- Documentation explaining which New Approach Directives apply to the product and how it is met
- European Union exam certificates, if any
All these documents should be stored together in a technical file.
In the implementation of the CE Mark, it helps to obtain assistance from accredited institutions to fully implement the requirements of the relevant instruction, perform tests and analyzes where necessary, to obtain compliance with relevant standards, and to support technical completion adjustments. Authorization bodies direct the use of understandable CE marking in accordance with product regulatory guidelines. In this case, product collection is done to find the right requirements, product conformity testing is performed according to European Union compliant standards, the technical file is prepared, user instructions are written and evaluated, the European Union approval announcement is confirmed and products are monitored with CE Marking.
Our company also provides CE marking services within certification services. As a result of these services, businesses are able to produce high quality, high performance, and quality products in a safe, fast and uninterrupted way.
The marking services provided within the certification services are one of the services provided by our organization in this regard. Many other certification functions are available.