CE Marking

 The CE marking informs us that the product meets the requirements of the main EU directives. It is mandatory for a wide range of products sold within or exported to the European Union.

Purpose

The CE declaration of conformity and the CE marking are the passport that allows products to circulate freely within Europe. The need to remove technical barriers to the free movement of products was established in the 1957 Treaty of Rome (Articles 100 & 30–36).

Anyone wishing to sell their products within the European Union or the European Economic Area must demonstrate their compliance with European directives. This also applies to manufacturers wishing to import products from a non-EU country to an EU member state.

The Directives replace the standards in force in individual countries, primarily with regard to safety.

Advantages

The CE marking on a product:

indicates that the product can be legally sold within the European Union and the European Economic Area. Some countries outside the European Union are also beginning to recognize it, but for now, it is not mandatory (and therefore remains voluntary).
it guarantees that the product can move freely within the European single market;
it indicates to customers that the product meets minimum safety and quality requirements;
compliance with the Directives is a requirement that binds the manufacturer or its exporter. Penalties for failure to CE mark a product can be severe.

The Evolution of the CE Marking

In 1985, the principle was established that a product legally marketed in one Member State can also be legally marketed in the territory of other Member States. Furthermore, safety, health, and environmental protection requirements needed to be harmonized throughout Europe through Community Directives. The adoption of a new strategy for technical harmonization and standardization, later referred to as the "new approach," was the key element in this unification process.

It was established that:

Community directives, which, once implemented by the Member States, become binding law, establish the essential requirements for health, safety, hygiene, and environmental protection.
The additional technical specifications are defined by "harmonized" Technical Standards developed by the European Standardization Institutes—CEN, CENELEC, and ETSI—under mandate from the Commission. These standards must be transposed into national technical standards, and any conflicting standards must be withdrawn. The technical standards are not binding; manufacturers who do not apply them are responsible for demonstrating that their product otherwise meets the essential safety requirements set forth in the directives. Conversely, products manufactured in accordance with harmonized standards enjoy a presumption of conformity with the essential requirements of the directives.
In the absence of harmonized standards, and on a transitional basis, Member States are required to accept as compliant with the essential requirements products manufactured according to purely national standards of origin, which have been subject to a specific recognition procedure by the Commission.

The Global Approach

A new milestone was reached in 1993 with Council Decision 93/446/EEC, which introduced the Modular System, unambiguously identifying the principles and procedures for CE conformity assessment and the affixing of the CE marking. The EC conformity assessment can be performed using one or more of the following modules, as required by the relevant directive:

Module A (Internal Production Control)
Module B (EC Type Examination)
Module C (Conformity to Type)
Module D (Production Quality Assurance)
Module E (Product Quality Assurance)
Module F (Product Verification)
Module G (Unique Product Verification)
Module H (Full Quality Assurance)
All modules require the intervention of a third-party body called a Notified Body, except Module A.

They cover only the legal aspects,
focus on the essential safety requirements,
introduce the principle of presumption of conformity for CE-marked products accompanied by a Declaration of Conformity;
they refer to the voluntary use of harmonized technical standards;
they assign the manufacturer (or its authorized representative) the responsibility for issuing the EC Declaration of Conformity and affixing the CE marking.
Product categories for which CE certification is mandatory

Steel
Concrete
D M
Gas appliances
Elevators
Technical aspects of the CE Marking
Weighing instruments
Gates, doors, and closures in general
Personal protective equipment (PPE)
Medical devices
Toys