The CE marking on products covered by the New Approach Directives imposes certain obligations on the part of the manufacturer. For example, you must first of all perform a risk analysis of these products. What risks does the product contain, what is the magnitude of the risks in terms of people, animals, goods and environmental conditions or what solutions can be applied to mitigate these risks in accordance with legal regulations?
The answers to all these questions should be put forward by the risk assessment study. The manufacturer is also obliged to provide a user manual explaining the intended use of the product and prepared in the user language. These operating instructions must also contain instructions, prohibitions and warnings for installation, inspection and maintenance of the product.
Another fundamental obligation of the manufacturers is to prepare and sign the declaration of conformity to the European Union. Producers must declare that the product complies with the relevant directives, legal regulations and standards.
Finally, the manufacturers have to prepare a technical file and put the technical documents into the file. The technical file must contain design data, drawings, calculations and test reports indicating that the product meets the basic requirements as well as the above-mentioned documents.
Until recently, there were differences in trade regulations between European countries, and life was very difficult and costly for traders. As each country had to comply with its own legal regulations, the products had to be approved by a competent authority at all times. After the end of the Second World War, European countries began to make agreements for the free trade of goods. As a result, new partnerships were established between the countries. Within this framework, the Treaty of Rome in 1958 established the European Economic Community (Common Market). In 1985 the New Approach was introduced. In 1987, the CE Mark was introduced for the first time for the products. In 1992 was designated the European Economic Zone. The Maastricht Treaty in 1993 established the European Union. In 1995, the machinery directive for new machines was issued and in 1997 the directive for the safe use of work equipment was issued. In 2008, a new legal framework for product marketing was created. In 2009, a radical reform was made in both the policy and decision-making processes of the European Union.
As can be seen, the successive steps in the implementation of CE Certificate, today, many products other than cosmetics, pharmaceuticals, food and chemicals are provided free circulation within the borders of the European Union and a number of obligations have been imposed on manufacturers as described above.
Although our country is not a member of the European Union or a member of the European Economic Area, it has adapted the New Approach Directives to its own domestic law and participated in CE marking.
In fact, there is a generally accepted but incorrectly known phenomenon in our country. The CE Certificate appears to be mandatory only for products to be shipped to the countries of the European Union, but in reality the CE Mark is a legal obligation in our country for all products covered by the relevant legal regulations.
The CE marking process operates in two ways. For some products it is sufficient for the manufacturer to declare conformity and to put CE marking on the product. Some products require a notified body. For product groups with a high level of risk, it is essential to go to a notified body.
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.