CE Marking Consulting

CE marking is a conformity mark indicating that a product complies with the European Union's applicable directives and may circulate freely in the EU market. For Turkish manufacturers, CE marking is a prerequisite for exporting products to EU countries. Under the "New Approach Directives" introduced in 1985, more than 25 directives apply to different product groups. CE marking, which is the manufacturer's responsibility, declares that the product meets the EU's minimum safety, health and environmental requirements.

Which Products Require CE Marking?

The CE Marking Process

• Directive identification: The EU directive(s) applicable to the product are determined. A product may be subject to more than one directive.
• Harmonized standard analysis: The EN standard(s) that can be used to demonstrate compliance with the directive are identified (EN 60335, EN 60601, EN 12100, etc.).
• Selection of conformity assessment procedure: The module to be applied is determined according to the directive and the product's risk class (Module A self-declaration, B+C type examination, F production control, etc.).
• Notified Body selection: For high-risk product groups, an EU-approved Notified Body is required. A suitable body is selected from the NB-CERT list.
• Technical file preparation: A technical file consisting of documents such as technical drawings, calculations, test reports, the user manual and the risk assessment is prepared.
• Testing: The product is tested in an accredited laboratory for conformity with the harmonized standards.
• EU Declaration of Conformity (DoC): A document signed by the manufacturer, declaring the product's conformity with all applicable directives, is issued.
• CE labelling: The CE mark is applied to the product or its packaging with the correct size, proportions and placement.

Self-Declaration vs Products Requiring a Notified Body

For low-risk products (for example, simple electrical appliances), the manufacturer may declare the CE mark under its own responsibility (self-declaration). However, for high-risk products, the involvement of a Notified Body (NB) is mandatory:

• Medical devices (Class IIa and above)
• Pressure equipment (Category II and above)
• Lifts
• Fire and smoke alarm systems
• Certain categories of personal protective equipment
• Construction products (within the scope of the CPR)

CE marking is not a "seal of quality"; it is a "declaration of conformity". The manufacturer is legally responsible for the accuracy of this declaration. Incorrect CE marking can lead to product recalls and liability for damages in the EU market.

Frequently Asked Questions

1. Is there a Turkish equivalent of CE for products manufactured in Turkey?

   For the Turkish market, there is a "National Approval" marking (obtained from bodies authorized by the relevant Ministry). However, if you intend to export to the EU, CE marking in accordance with the EU directives is mandatory.

2. From which country can a Notified Body be selected?

   Any NB located in the EU or in a country that has a mutual recognition agreement with the EU may be selected. Turkey has TÜRKAK-accredited Turkish NBs (for example, TSE, TUV Turkey). Turkish NBs may be preferred in terms of cost and ease of communication.

3. How long does the CE process take?

   2-4 weeks for simple products. 6-18 months for complex products (Class III medical devices, Category IV pressure equipment). For medical devices within the scope of the MDR, the NB assessment period can extend up to 12-24 months.

4. Does the CE certificate have a validity period?

   The CE mark itself is not time-limited; it remains valid for as long as the product is manufactured. However, when directives or standards change, the technical file must be updated and, if necessary, retesting must be carried out.