What is CE?

The acronym “CE” is the abbreviation of the French phrase “Conformité Européenne” standing for European Conformity.

The “CE” marking on a product indicates it complies with the European Regulations’ requirements and can be freely traded and distributed between the EU Member States.

The “CE” certificate or declaration of conformity is issued for a specific product or product line range.

By affixing the CE marking to a product, the manufacturer or the distributor declares, under his sole responsibility, he/she complies with all relevant Community provisions, thus ensuring the validity of the product in question for sale in the European Economic Area (EESC, the 27 EU Member States and the EFTA countries Iceland, Norway, Liechtenstein), as well as in Turkey. Products manufactured in third countries and sold in the EEA and Turkey are also required to be CE marked (about products subject to this requirement.

CE marking does not indicate a product was made in the EEA, but merely states the product is assessed before being placed on the market and meets the relevant legislation requirements (e.g. harmonised safety level). It means the manufacturer has verified the product complies with all relevant essential requirements of the applicable directive or, if stipulated in the directive, it has been examined by a notified conformity assessment body. It is the manufacturer’s responsibility to carry out the conformity assessment, draft the technical file, issue the EC declaration of conformity and affix the CE marking on the product. Distributors must verify the presence of both the CE marking and the necessary supporting documentation. If the product is being imported from a third country, the importer has to verify that the non-EU manufacturer has undertaken the necessary steps and the documentation is available upon request.

Target Group

The CE marking procedure is addressed to all manufacturers of product categories included in the New Approach Directives, seeking to distribute their products within the Community market. The specific procedures also apply to all non-EU importers.

Indicatively, the categories of products included in the New Approach Directives required to be CE marked are the following:

• Almost all building materials used in any type of construction (e.g. aggregates, frames, wood, bricks, lime, cement, paving slabs, scaffolding, etc. ), machinery, toys, personal protective equipment, explosives for civil use, equipment and protective systems for use in potentially explosive atmospheres, medical equipment, medical devices, medical devices, in vitro diagnostic equipment, lifts and hoists, telecommunications terminal equipment, transportable pressure equipment, appliances and fittings burning gaseous fuels, electrical equipment, simple pressure vessels, measuring devices, hot water boilers, recreational craft, marine equipment, non-automatic weighing instruments, lighting fabrics, playground equipment and others

Business benefits

The products required to be CE marked demonstrate the manufacturer’s compliance with legislation requirements and are a prerequisite in order for the products’ legitimate trading within the Community market.

The requirements’ implementation and CE marking benefits the company in the following ways:

• Enhanced product reliability
• Delivering safe products to consumers
• Less production failures by implementing quality control procedures
• Increased sales by attracting new customers and entering new markets

Role of IDEC S.A.

IDEC, having extensive experience in developing procedures and supporting standard-based certifications, provides the company with the necessary know-how to develop the required technical file and production & control system, based on the CE marking respective harmonized standard requirements:

• Identification of the directives and harmonised standards applying to each product
• Identification of each product’s requirements to be fulfilled
• Verifying the need to involve an independent notified body for a CE certificate assessment and issuance
• Procedural management and communication with certification bodies.
• Required initial type tests’ (ITT – Initial Type Tests) implementation support, legislation and relevant standards’ compliance check
• Drafting of the required Technical File and all supporting technical documents
• Production Control System Development
• Staff training
• Carrying out inspections to ensure to ensure system’s proper implementation
• Consulting support for CE Declaration of Conformity and product marking issuance
• In addition to the above, in case a notified body check is required to issue the CE certificate, the following actions must be undertaken:
  
  
  • Make all the necessary arrangements with the certification body
  • Support the Certification Body during the inspection
  • Settling any outstanding issues (non compliance) that may arise
  • Support the company following its certification by carrying out internal inspections and providing consulting services.

See also