CE Marked Products

Products that are required to bear the CE marking are defined separately in the so-called New Approach Directives. The free movement of goods is the sole goal of the European market. The New Approach Directives introduced to achieve this aim are based on the prevention of trade barriers, mutual recognition and technical compliance.

These directives, which must be transposed by each Member State into their national legal system, allow for the freedom of movement of products legally produced and marketed in a country within the borders of the European Union.

In this regard, the European standardization system has been quite successful in removing technical barriers to trade. In fact, the New Approach program was originally designed in the early 1980 years. Its implementation was made by the Council Decision in 1985 on technical compliance and a new approach to standards.

These directives define basic requirements such as the protection of health and safety that products placed on the market must meet. Organizations that set European standards prepare relevant technical specifications that meet the essential requirements of the directives, and compliance with them ensures compliance with the requirements of the directives.

The basic principles on which the New Approach Directives are based can be listed as follows:

• There is a clear distinction between European Union regulations and European standards.

• The legal harmonization of the Arupa Union is limited to the basic requirements for the free movement of products within the community.

• The task of preparing the relevant technical specifications is given to standardization bodies.

• Products manufactured in accordance with harmonized standards are assumed to meet basic requirements.

• Standards are not mandatory, implementation is optional. It is possible to choose alternative means, but the manufacturer must prove that the products comply with the essential requirements of the directives.

• The standards provide quality assurance in relation to the essential requirements of the directives.

• The obligations of government agencies to protect the health of people and the safety of the environment still persist. Therefore, it has to continue to carry out market surveillance.

• Within this framework, member states may take various measures and impose sanctions to withdraw unsafe products from the market.

Compared to the New Approach Directives and previous directives, significant improvements have been achieved since 1985. For example, CE marking is spread over a wide range of products, such as machines and toys. The directives now cover horizontal risks rather than specific products. A closer co-operation has been established between government agencies and market operators such as manufacturers, importers, assembly companies and distributors. In addition to voluntary harmonization (the double regime), general harmonization has been revised, which means that there is a common legal regulation that replaces different national laws.

New Approach Directives have a broad flexible structure. Rather than elaborating on technical solutions, it focuses on what needs to be achieved and offers different options for conformity assessment.

The products that are required to bear the CE marking are:

• Radio equipment

• Medical devices

• Active implantable devices

• In vitro diagnostic medical equipment

• machinery

• Products containing certain hazardous substances (RoHS)

• Electrical and electronic equipment

• batteries

• Explosives

• Packing materials

• Personal protective equipment

• Toys

• Explosives for civil use

• Pyrotechnic items (fireworks)

• Measuring instruments

• Non-automatic weighing instruments

• Cable car facilities

• lifts

• Simple pressure vessels

Within the scope of certification services, our company also provides services on products that have the CE mark. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.

In the scope of certification services, services related to the products with CE marking are only one of the services provided by our organization in this respect. Many other certification services are also available.