Certification and CE Marking Services

The CE marking is a mark must be affixed to certain types of products in order to certify their compliance with all EU applicable directives.

The affixing of the mark is prescribed by law in order to market the product in the countries of European Economic Area (EEA). The presence of the CE mark guarantees consumers that the product has the necessary security features to use.

Examples of some directives require the CE mark are:

• Low Voltage Directive
• Machinery Directive
• Directive compatibility Electromagnetic
• Directive for Medical Devices

In 1985 new standards were adopted for the approximation of the laws of member states. It was agreed that:

• Directives cover the essential health, safety, hygiene and environmental protection.
• The further technical specifications are defined by technical standards "harmonized" European standards institutes developed by CEN, CENELEC and ETSI-order of the Commission.
• These rules must be translated into mandatory national technical rules, regulations and any conflict must be withdrawn.
• The technical standards are not binding nature, it’s up to the manufacturer that fails to apply the standards, to prove that their product meets the essential requirements by other means of security required by the Directives. Vice versa, the product made on the basis of harmonized standards benefit from a presumption of conformity with essential requirements of directives.
• In the absence of harmonized standards, and on a transitional basis, Member States are required to accept as meeting the essential requirements according to products made of purely national origin, which was the subject of a particular procedure of recognition by the Commission.

Conformity assessment can be performed using one or more of the following modules, as required by Directive reference:

• 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 (Unit verification product)
• Module H (full quality assurance)

The guidelines, subsequent to the May 7, 1985, are in accordance with the "New Approach":

• cover only the legal aspects;
• focus on the essential safety requirements;
• introduce the principle of presumption of conformity for products marked and accompanied by the EC Declaration of Conformity;
• refer to the voluntary use of harmonized standards;
• give the manufacturer’s responsibility (or representative’s responsibility)to release the Declaration of Conformity and affix the CE marking.

In most cases the manufacturer may proceed independently to assess conformity of their product while maintaining appropriate documentation (technical file).

In other cases, for those products that the European legislator considered potentially riskier, it is expected the intervention of a third body part, or Notified Body, which, alternatively or in combination:

• check and approve, by examinations and tests on a prototype, product design;
• endorse each copy of a unified product (only the production / installation, or design);
• approves and monitors the system manufacturer`s guarantee (assuming as a reference to the UNI EN ISO 9000): quality assurance in production or products.