CE Certification indicates that a product placed on the European Economic Area (EEA) market complies with applicable European Union (EU) requirements for health, safety, and environmental protection.
The CE marking is relevant to many products sold within the EEA, but it does not apply universally. Manufacturers must first determine whether their product falls under legislation requiring CE marking.
What Is CE Certification?
CE marking is a manufacturer’s declaration that a product meets the applicable EU requirements.
Depending on the product and legislation involved, the conformity assessment process may require:
- Identifying applicable EU legislation
- Determining applicable product requirements
- Conducting risk assessment
- Applying relevant harmonised standards where appropriate
- Performing testing and conformity assessment
- Preparing technical documentation
- Preparing an EU Declaration of Conformity
- Affixing the CE marking
For certain higher-risk products, a Notified Body may need to be involved in the conformity assessment.
Who Needs CE Certification?
CE marking can apply to products such as:
- Machinery
- Medical devices
- Electrical and electronic equipment
- Personal protective equipment
- Toys
- Pressure equipment
- Radio equipment
- Construction products
- Certain measuring instruments
The exact requirements depend on the product category and applicable EU legislation.
CE Certification Process
The process generally begins with identifying the legislation applicable to the product.
1. Identify Applicable Requirements
The manufacturer determines which EU legislation applies and what essential requirements must be met.
2. Product Risk Assessment
Potential risks associated with the product are assessed and appropriate measures are implemented.
3. Conformity Assessment
The manufacturer follows the applicable conformity assessment procedure. Depending on the product, this may involve internal production controls, testing, or assessment by a Notified Body.
4. Technical Documentation
Technical documentation must be prepared and maintained to demonstrate conformity.
5. EU Declaration of Conformity
The manufacturer prepares and signs the applicable EU Declaration of Conformity.
6. CE Marking
Once the applicable conformity requirements have been fulfilled, the manufacturer can affix the CE marking according to the relevant rules.
Benefits of CE Marking
CE marking can help manufacturers:
- Access applicable European markets
- Demonstrate regulatory conformity
- Establish structured product-compliance processes
- Improve risk management
- Support product safety
- Provide evidence of compliance to relevant authorities and customers
CE Certification vs. ISO Certification
CE marking and ISO certification are not the same.
CE marking relates to compliance with applicable EU product legislation.
ISO certification generally relates to conformity with an ISO management-system or product-related standard, depending on the applicable standard and certification scheme.
A product may require CE marking regardless of whether the manufacturer has an ISO-certified management system.
Conclusion
ce certification is commonly used to describe the conformity process associated with CE marking for products covered by applicable EU legislation. Manufacturers should identify the specific legal requirements for their product before determining the appropriate assessment procedure.
For complex or regulated products, obtaining professional regulatory guidance can help ensure that the conformity assessment, technical documentation, and declaration of conformity are properly prepared.