CE Certification and Accreditation

CE Certification and Accreditation: Differences Between Notified Bodies and Accredited Laboratories

The CE marking process is filled with technical requirements, and among the most important stakeholders in this process are Notified Bodies and accredited testing laboratories. These two types of institutions are often confused; however, their roles, authorities, and contributions to the CE process differ significantly.

In this article, we distinguish between Notified Bodies and accredited laboratories within the scope of CE certification, clarify their differences, and explain how SERTİFİKE supports manufacturers in these processes.

1. What Is a Notified Body?

A Notified Body (NB) is an organization that has been authorized under a specific regulation or directive by the European Commission and is officially registered in the NANDO database.

Their duties include:

• Evaluating products according to the conformity assessment module
• Conducting procedures such as type examination (Module B) and system audit (Module D)
• Issuing certification or conformity reports before CE marking

When is it mandatory?

A Notified Body is only required for certain regulations and high-risk products, for example:

• Medical Devices Regulation (MDR)
• Lifts Directive
• ATEX Directive
• Gas Appliances Directive

In these cases, the manufacturer’s self-declaration is not sufficient; NB assessment is mandatory.

2. What Is an Accredited Test Laboratory?

Accredited laboratories are typically authorized by a national or international accreditation body according to EN ISO/IEC 17025.

Their duties include:

• Performing tests according to relevant EU harmonized standards
• Issuing technical reports containing test results
• Providing measurements and evaluations within the scope of directives such as EMC, LVD, RoHS, and RED

Note:
Accredited laboratories do not issue certificates; they only report test and measurement results, which form part of the technical documentation.

3. What Are the Key Differences?

Criteria	Notified Body	Accredited Laboratory
Authority Source	European Commission (Registered in NANDO)	National accreditation body (TÜRKAK, UKAS, DAkkS, etc.)
Role	Conformity assessment, certification	Testing, measurement, analysis reporting
Requirement	Mandatory only under certain directives	Preferred if technical requirements apply
Issuance of Documents	Certificate / conformity report	Test report
Manufacturer’s Role	Transfers conformity assessment to NB	Final responsibility remains with the manufacturer

4. How Does SERTİFİKE Support You?

SERTİFİKE assists manufacturers throughout the CE marking process by establishing effective communication with both accredited laboratories and Notified Bodies, offering support in the following areas:

• 📄 Determines whether your conformity module requires involvement from a Notified Body
• 🧪 Identifies the appropriate test standards and laboratories for your product
• 🔍 Verifies that accredited lab reports meet technical documentation requirements
• 📌 Organizes the preparation of technical documents for communication with an NB if needed

Thanks to this support, manufacturers can complete the CE marking process with the correct procedures and without time loss.

5. Conclusion

Notified Bodies and accredited laboratories operate at different stages of the CE process and have distinct roles and responsibilities. Whether you need one or both depends on your product’s risk classification and applicable regulations.

SERTİFİKE helps accurately analyze these distinctions, ensures that the process is carried out with the right institutions, and secures your product’s technical compliance.