CE Marking and Conformity Assessment Processes: Step-by-Step Guide
For manufacturers seeking to enter the European market, the CE mark is a critical certification that demonstrates compliance with safety, health, and environmental standards. However, obtaining this mark requires navigating a specific process. In this guide, we will outline the step-by-step process for obtaining the CE mark and explain how SERTIFİKE supports you through each stage.
Step-by-Step Guide to Obtaining the CE Mark
The CE marking process involves specific steps to prove that a product complies with the relevant regulations and standards of the European Union. Below are the key steps in this process:
Determining the Product Category
Every product is evaluated under a specific EU directive or regulation. Identifying which directives apply to your product is the first step in the process.
- Example Regulations:
- Machinery Directive (2006/42/EC)
- Construction Products Regulation (305/2011/EU)
- Low Voltage Directive (LVD)
- Electromagnetic Compatibility (EMC) Directive
- Medical Devices Directive (2017/745)
- ATEX Directive (2014/34/EU)
SERTIFİKE’s Role: We analyze your product and identify the applicable directive, forming the foundation for the compliance process.
Identifying Essential Requirements
Each directive has specific requirements, covering safety standards related to the product's design, manufacturing, and use.
- Example Requirements:
- Electrical safety
- Mechanical durability
- Environmental compliance (RoHS, REACH)
SERTIFİKE’s Role: We outline all technical requirements your product must meet and provide a comprehensive checklist.
Selecting the Conformity Assessment Method
The appropriate evaluation module to prove compliance is chosen based on the product type and the relevant directive.
- Common Modules:
- Self-testing by the manufacturer (Module A)
- Design approval by a Notified Body (Module B)
- Inspections and product testing by a Notified Body (Modules C, D, E, F, H)
SERTIFİKE’s Role: We determine the required assessment method and handle communications with Notified Bodies when necessary.
Testing and Inspection Processes
Products undergo laboratory tests to verify compliance with the applicable standards.
SERTIFİKE’s Role: We ensure tests are conducted in ISO/IEC 17025-accredited laboratories and validate the results.
Preparing the Technical File
A technical file must be prepared to obtain the CE mark. This file includes all documents that prove the product meets the necessary requirements.
- Contents of the Technical File:
- Product design and manufacturing details
- Test results and reports
- Risk assessment documents
SERTIFİKE’s Role: We prepare all technical documentation on your behalf and compile a complete file.
Preparing the Declaration of Conformity (DoC)
The Declaration of Conformity is a document where the manufacturer declares that the product complies with the relevant directives and standards.
SERTIFİKE’s Role: We assist in drafting the DoC, ensuring full compliance with legal requirements.
Placing the CE Mark on the Product
Once all steps are successfully completed, the CE mark is affixed to the product. It signifies that the product can legally be sold in the European market.
- Important Considerations:
- The mark must be placed visibly and in the correct proportions.
- It must not provide misleading information.
SERTIFİKE’s Role: We guide you in properly placing the CE mark.
Advantages of Working with SERTIFİKE
At SERTIFİKE, we provide end-to-end guidance throughout the CE marking process. With our expert team and extensive service network, we are here to support you every step of the way.
Our Services:
- From product analysis to selecting the applicable directive
- From preparing the technical file to facilitating testing processes
- From drafting the Declaration of Conformity to applying the CE mark to your product
Why Choose SERTIFİKE?
- Fast and efficient results
- Expert and experienced team
- Strong partnerships with Notified Bodies
- Competitive pricing with high-quality services
