What Is CE Marking?
CE marking is the conformity marking that shows a product meets the essential safety, health, environmental and — where applicable — performance requirements set out in European Union legislation. By affixing the CE mark the manufacturer declares, under its own responsibility, that the product complies with the relevant EU directives and regulations. The mark enables free movement of the product within the European Economic Area (EEA) and in Türkiye.
Under the Customs Union and technical legislation alignment with the EU, Türkiye applies the CE marking system. Compliance with CE legislation is therefore also required when placing relevant products on the Turkish market.
Is CE Marking a Quality Certificate?
No. CE marking:
- Is not a quality certificate.
- Does not guarantee a particular quality level.
- Shows that the product meets the minimum safety and legal conformity requirements of the applicable EU legislation.
Which Products Require CE Marking?
CE marking is mandatory only for products covered by the EU harmonized legislation, including:
- Machinery
- Electrical and electronic equipment
- Radio and wireless equipment
- Construction products
- Pressure equipment
- Gas appliances
- Lifts
- Personal protective equipment
- Toys
- Medical devices
- Measuring instruments
- Marine equipment
- Cableway installations
- Explosives and pyrotechnic articles
CE Directives and Regulations
The principal directives and regulations requiring CE marking under the EU New Approach and New Legislative Framework (NLF) are:
| Legislation | Scope |
|---|---|
| Machinery Regulation (EU) 2023/1230 | Machinery and related safety components (applicable from 14 January 2027) |
| 2006/42/EC Machinery Directive | Applies until the new Machinery Regulation enters into force |
| 2014/35/EU Low Voltage Directive (LVD) | Electrical equipment 50-1000 V AC and 75-1500 V DC |
| 2014/30/EU Electromagnetic Compatibility Directive (EMC) | Electromagnetic compatibility of electrical and electronic equipment |
| 2014/53/EU Radio Equipment Directive (RED) | Wireless communication equipment |
| 2014/34/EU ATEX Directive | Equipment for use in explosive atmospheres |
| 2014/68/EU Pressure Equipment Directive (PED) | Pressure vessels, piping, safety accessories |
| 2010/35/EU Transportable Pressure Equipment Directive (TPED) | Gas cylinders and transportable pressure receptacles |
| 2016/426/EU Gas Appliances Regulation (GAR) | Gas-burning appliances |
| 305/2011/EU Construction Products Regulation (CPR) | Construction products |
| (EU) 2024/3110 New Construction Products Regulation | Will gradually replace the current CPR |
| 2014/33/EU Lifts Directive | Lifts and safety components |
| 2014/29/EU Simple Pressure Vessels Directive (SPVD) | Series-produced welded pressure vessels |
| 2013/29/EU Pyrotechnic Articles Directive | Fireworks and pyrotechnic articles |
| 2014/28/EU Explosives for Civil Uses Directive | Commercial explosives |
| 2016/424/EU Cableway Installations Regulation | Cableways and similar systems |
| 2014/31/EU Non-Automatic Weighing Instruments Directive (NAWI) | Scales |
| 2014/32/EU Measuring Instruments Directive (MID) | Meters and measuring devices |
| 2014/90/EU Marine Equipment Directive (MED) | Equipment used on ships |
| (EU) 2016/425 Personal Protective Equipment Regulation (PPE) | Helmets, gloves, safety harnesses, etc. |
| (EU) 2017/745 Medical Devices Regulation (MDR) | Medical devices |
| (EU) 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR) | Laboratory diagnostic devices |
| 2009/48/EC Toy Safety Directive | Toys |
| 2011/65/EU RoHS Directive | Restriction of hazardous substances in electrical and electronic equipment (assessed within CE marking) |
How Does the CE Certification Process Work?
- Determining the applicable EU directive or regulation.
- Identifying the harmonized European standards (EN standards).
- Performing the risk analysis.
- Carrying out the necessary laboratory tests.
- Preparing the Technical File.
- Performing the conformity assessment.
- Assessment by a Notified Body where required.
- Drawing up the EU Declaration of Conformity.
- Affixing the CE marking to the product.
Is a Notified Body Required for Every CE Product?
No — it depends on the product. For many low-risk products the manufacturer may self-assess conformity and affix the CE mark. For higher-risk products EU legislation requires the involvement of a Notified Body; certain medical devices, personal protective equipment and specific construction products fall into this category.
Manufacturer's Responsibilities
- Verifying that the product complies with the relevant legislation,
- Preparing and retaining the technical file,
- Drawing up the EU Declaration of Conformity,
- Monitoring conformity after the product is placed on the market.
What Is the CE Technical File?
The CE Technical File is the complete set of technical and administrative documents demonstrating that a product has been designed and manufactured in accordance with the relevant EU technical legislation and has undergone the required conformity assessment procedures. It is the key evidence that the product meets safety, health, environmental and performance requirements, and it is mandatory for every CE-marked product unless the applicable legislation states otherwise.
When Is the Technical File Requested?
The technical file is not normally submitted to any body, but it may be requested:
- During market surveillance and inspection activities,
- By competent public authorities,
- During customs inspections,
- During Notified Body assessments (where the legislation requires),
- In complaint or accident investigations relating to product safety.
An incomplete or inadequate technical file may invalidate the CE marking, lead to product recall, administrative sanctions and fines, and increase the manufacturer's legal liability. The technical file is therefore not merely a folder of documents but a comprehensive and systematic body of documentation evidencing the entire conformity assessment process, from design and manufacture through testing and risk assessment.
Contact us for your CE certification and technical file needs.