CE Marking and CE Certificate Consulting

What Does CE Stand For?

CE stands for Conformite Europeenne, French for European Conformity. It refers to the technical standards applied to products in certain product groups so that they can circulate freely within the European market, and to the mark affixed to products to signal that conformity. CE is also referred to as the CE mark, the CE certificate, or the CE label. As Sistem Patent Kalite, we provide specialist consultancy on CE marking, testing, and certification.

CE marking confirms that a product complies with the applicable EU requirements. A point to keep in mind: the CE mark is not a commercial warranty or guarantee of the product.

The standards used in the conformity assessment during the CE marking process vary by product group. Each product group sets out the safety conditions the product must meet with respect to human health and the environment, and confirms that the product conforms to those conditions.

CE Marking and the Manufacturer

For the manufacturer, placing the CE mark on a product means not only accepting responsibility for the product but declaring that all applicable regulatory requirements have been met. A product bearing the CE mark is presented as not causing harm to people, to the environment, or to the ecological system.

When the CE mark is applied to a product, conformity is evaluated using the conformity assessment route required for that product. The assessment route varies with the product's risk classification. For risk-graded products, the manufacturer is required to demonstrate that evaluation and testing have taken place throughout the production process and to keep the associated records. Depending on the product, risk classes may run A to H, or Systems 1 to 4, or follow a basic risk grading.

If a user is harmed during use of the product, the manufacturer is responsible for demonstrating that the harm did not originate from the manufacturing process and that the applicable requirements were met. This proof is provided through a technical file and records covering every stage from design to final sale, which the manufacturer is obliged to retain.

Every manufacturer is required to monitor all published standards relevant to its products and to ensure conformity with them.

What the Manufacturer Must Do for CE Marking

• Follow the processes set out in the regulations for the product group in question.
• Prepare the product technical file and keep the associated records.
• Carry out the required product tests, directly or through a contracted laboratory, and keep the test records.
• Prepare user instructions and hazard information in a form that consumers in the country of sale can understand.
• Ensure product traceability.
• Retain the product technical file for at least ten years.
• Affix the CE mark on the product in the form required by the regulation.
• Where a notified body is required, have the product assessed and tested by that body.

CE Marking From the Importer's Perspective

Importers bringing products into the EU from outside must check that the product complies with EU requirements on environment, health, and safety. The import-side checks include:

• Is there any nonconformity with the applicable technical regulations that would prevent entry into the European market?
• Does the product have a technical file and a declaration of conformity, and has their accuracy been verified?
• Is the manufacturer reachable for ongoing communication?

CE Marking From the Distributor's Perspective

Distributors must ensure that products entering the European market and Turkey are checked for conformity with CE legislation and the applicable standards. For product groups where the CE mark is mandatory, the distributor must ensure that the product carries the CE mark and is accompanied by the technical file and user documentation. Both importers and distributors must consider their legal responsibilities when placing the product on the market. Otherwise they are liable for any harm arising from the product.

What the CE Mark Means for the Consumer

From the consumer's perspective, the CE mark is an important signal of product safety. Consumers should pay attention to the markings on the product and read the accompanying user manual carefully. For toys, for example, the age range for use is shown next to the CE mark, so a toy being bought for a child should be checked for both the CE mark and the appropriate age range. If a product such as a toy lacks the CE mark where the mark is required, the situation should be reported to the relevant Ministry.

Which Products Must Carry the CE Mark?

Beyond individual products, Turkey has harmonised regulations covering product groups and directives. These regulations set the minimum obligations for the relevant product groups. The directives covering products that must carry the CE mark include:

• Construction products (305/2011/EC)
• Lifts (95/16/EC)
• Gas appliances (2009/142/EC)
• Pressure equipment (97/23/EC)
• Hot-water boilers (92/42/EC)
• Toys (2009/48/EC)
• Machinery (2006/42/EC)
• Personal protective equipment (89/686/EC)
• Medical devices (93/42/EC)
• In vitro diagnostic medical devices (98/79/EC)
• Non-automatic weighing instruments (2009/23/EC)
• Low-voltage equipment (2006/95/EC)
• Electromagnetic compatibility (2004/108/EC)
• Simple pressure vessels (2009/105/EC)
• Active implantable medical devices (90/385/EC)
• Equipment and protective systems for use in potentially explosive atmospheres, ATEX Directive (94/9/EC)
• Recreational craft (2013/53/EC)
• Radio and telecommunications terminal equipment (99/5/EC)
• Cableway installations (2000/9/EC)
• Explosives for civil uses (93/15/EEC)
• Measuring instruments (2004/22/EC)

In Which Countries Is CE Marking Mandatory?

The countries where products in CE-applicable product groups must carry the CE mark are:

• EU member states
• EFTA countries (Iceland, Norway, Liechtenstein)
• Switzerland
• Türkiye

The CE Marking Process, Step by Step

First, the risk level of the product requiring CE marking is established. The product's minimum risk grading and applicable norms are determined, and the required steps are set on that basis. The modules are:

• Identify all directives that apply to the product.
• Determine the conformity assessment modules of the applicable regulation and meet the requirements. Assessment modules include: Module A (internal production control), Module B (EU 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), and Module H (full quality assurance).
• Assemble the product technical information: technical drawings or figures, circuit diagrams, invoices for product materials, quality certificates for the materials used, test or trial records, production instructions, the EU Declaration of Conformity. The technical file must be retained for at least 10 years.
• The Declaration of Conformity must state: manufacturer name and address; product details (model, serial number, etc.); the standards and directives applied; a statement that the product meets the directive; a signature by the responsible person; the date of the declaration; and any additional norms and standards.

• The CE mark must be placed on the product in a visible, indelible location and in the required format.
• By affixing the CE mark, the manufacturer declares that the product meets all applicable essential requirements.
• The CE mark must be at least 5 mm in size.
• The CE mark must also appear on the packaging and on other descriptive documents.
• Where a notified body is involved, the body's identification number must be shown alongside the mark.

Our specialists at Sistem Patent Kalite can advise you on technical consultancy and certification for CE marking. Our offices in Izmir, Istanbul, Ankara, Bursa, Adana, Antalya, Konya, Kayseri, and Eskisehir are available to support you. When you reach any of these offices, our specialist team will work with you to obtain CE marking for your product.