Surveillance in CE Certification

Surveillance in CE Certification: What is Checked While the Product is on the Market?

A CE-marked product is approved for entry into the European Union market. However, this approval does not imply a perpetual safety guarantee. On the contrary, CE conformity must be maintained not only before the product is launched but also throughout its time on the market. That’s why surveillance is a crucial part of CE marking.

In this article, we detail how CE-certified products are monitored in the market, what is expected from manufacturers and importers, and how SERTİFİKE supports stakeholders during this process.

1. What is Surveillance?

Surveillance refers to the process of monitoring whether CE-marked products continue to comply with relevant EU legislation after entering the market. This process ensures that product safety is maintained over time.

2. What is Checked While the Product is on the Market?

2.1 Labeling and CE Marking

• Is the CE marking correctly placed on the product?
• Are the manufacturer, importer, and product details complete?
• Are the serial number, warning symbols, and technical information visible?

2.2 Technical File Accuracy

• Is the technical file of the product in line with current regulations?
• Are the user manual, risk assessments, and test reports complete?
• Do the documents reflect updates in the product version?

2.3 Sample Testing Under Market Surveillance

Authorities (such as Turkey’s Ministry of Trade or Ministry of Industry and Technology) may collect product samples from the market and subject them to testing. These tests may include:

• Electromagnetic Compatibility (EMC)
• Electrical Safety (LVD)
• Mechanical strength

3. Common Non-Conformities in Surveillance

• Incorrect placement of the CE mark
• Missing or incomplete Declaration of Conformity
• Incomplete or outdated technical file
• Failure to update tests according to revised directives or standards

Such deficiencies may result in product recalls or administrative fines.

4. How SERTİFİKE Supports You During This Process

To maintain the compliance of CE-marked products on the market, manufacturers need regular inspections and updates. SERTİFİKE provides structured support at every stage of the surveillance process:

🎓 Training Programs
We offer comprehensive training on CE marking, declarations of conformity, labeling, surveillance, and regulations. Content includes updated EU directives, harmonized standards, and case studies. 🔍 Pre-Audit Services
We conduct voluntary pre-audits to assess current conditions and identify gaps in CE marking or compliance. 🛡️ Internal Auditing Support
We help establish internal monitoring mechanisms to ensure the continued conformity of products. 🔄 Ongoing Surveillance Activities
We help periodically inspect products in the market for CE marking placement, labeling, and safety compliance.

SERTİFİKE is your partner in maintaining CE conformity – not just at the beginning, but for the entire product lifecycle on the market.

What Should Be Done When Changes Are Made to a Product with a CE Certificate?

The CE mark is a critical symbol that shows your product complies with European Union legislation. However, if any design, manufacturing, or software changes are made after a product has received CE certification, these changes may affect its conformity status.

So, what steps should you take as a manufacturer in such a case?

1. Why Are Changes Critical?

The CE Declaration of Conformity means the product has been assessed based on a specific technical file and test results. Any change to the product may affect:

• The applicable directives,
• The validity of the conducted tests,
• The accuracy of the risk assessment,
• The correctness of labeling and marking.

Therefore, even if a change seems “minor,” it could still impact the technical documentation and the Declaration of Conformity.

2. What Types of Changes Are Considered Critical?

Below are examples of changes that may require a reassessment of CE conformity:

Type of Change	Examples
Design	Changing body material, revising circuit structure
Software	Firmware updates, functional modifications
Manufacturing Location	Moving production to a facility in another country
Functionality	Adding a new feature, increasing automation
Standards Update	An update to an applicable EN standard

3. What to Do After a Change?

3.1 Conduct an Impact Assessment

Evaluate whether the change affects the product’s performance, safety, or conformity.

3.2 Update the Technical File

Revise the user manual, risk assessment, test reports, technical drawings, and all other documentation.

3.3 Perform New Tests If Necessary

If the existing test reports are no longer valid (e.g., due to a new EMC component), new tests should be conducted.

3.4 Revise the Declaration of Conformity

A new EU Declaration of Conformity should be issued based on the updated documentation.

4. How SERTİFİKE Supports You

SERTİFİKE provides technical support to help manufacturers assess the impact of post-certification product changes on CE conformity and manage the required processes:

• 📄 Labeling and Marking Compliance Checks
• 🧪 Planning and Managing Required Laboratory Tests
• 📌 Assistance in Updating the Declaration of Conformity

These steps help ensure your product remains valid in the market and avoids issues during inspections.

Final Note

Even “minor” changes made after CE certification can have serious technical implications. Keeping the conformity process transparent and up-to-date is vital for both legal compliance and brand credibility.

At SERTİFİKE, we assess the impact of changes on your CE compliance and help you maintain your strong position in the European market.