If you are manufacturing an electronic device and plan to market it in the European Union (EU), you’ve likely heard of the importance of CE certification.
CE, or European Conformity, is a compliance mark that demonstrates a device complies with all relevant EU directives. Many products, including electronic devices, are required by law to carry the CE mark in order to enter the market in the European Union.
Complying with CE regulations and receiving CE certification requires testing your device with a certified, accredited lab partner to confirm that it meets all relevant standards.
You might choose to achieve CE certification at the same time as FCC certification (required for access to the United States market), or when you specifically plan to start marketing your device in Europe.
Below, we’ve explained what the term “CE certified” means, as well as the basics steps involved in achieving CE compliance for your electronic device.
To request a free quote for testing and certifying your device, or to ask our engineers a question about the testing and CE compliance process, contact us online or call us at info@hbcompliance.com, (480) 684-2969.
What Does CE Certified Mean?
The term “CE certified” means that an electronic device has completed lab testing and is verified to meet the requirements of all relevant EU regulatory directives.
Devices that are CE certified can legally go on sale throughout the European Economic Area (a shared market made up of the EU countries, plus Norway, Liechtenstein and Iceland).
CE certification is a mark of conformity that many products sold within the European Union are legally required to meet. For electronics manufacturers, especially those interested in selling in the EU, understanding the CE mark is critical for regulatory compliance and market access.
CE Certification and Electronic Devices
If you plan to market your electronic device in the European Union, achieving CE certification is an important step. All electronic devices subject to EU regulatory directives must show that they operate within established limits for electromagnetic compatibility (EMC).
The European Union also has directives for electrical device safety, use of hazardous materials, and other areas that may apply to your device.
Most electronic devices fall under three primary EU directives for CE marking:
- Electromagnetic Compatibility (EMC) Directive. EMC testing ensures that electronic devices do not create, or are affected by, electromagnetic interference (EMI). Testing for this directive involves measuring your device’s emissions and EMI immunity.
- Radio Equipment Directive (RED). This directive applies to devices that use the radio frequency (RF) spectrum. It establishes limits to prevent electronic devices from emitting radio frequency interference.
- Low Voltage Directive (LVD). This directive sets safety standards for electronic devices that operate in the 15 to 1,000 volts alternating current (AC) and 75 to 1,500 volts direct current (DC) ranges.
CE Testing and Certification Process
To achieve CE certification and affix the CE mark to your device, you will need to complete the CE testing process. This involves testing your device in a lab setting to verify that it’s compliant with all relevant regulations, and preparing documentation to demonstrate its compliance.
The specific steps involved in testing and compliance may vary based on your device type and the directives that apply. For most electronic devices, the process includes:
- Identify relevant directives and standards. The first step in achieving CE certification is identifying the relevant standards. Most electronic devices sold in the EU are subject to the EMC DIrective and Low Voltage Directive. In certain cases, additional directives, such as the Radio Equipment Directive and/or Restriction of Hazardous Substances (RoHS) Directive, may apply to your device.
- Conduct a conformity assessment. Your device will need to be tested to verify that it complies with the relevant standards. A range of tests are performed to check that your device complies with all relevant EU directives.
- Create a technical file. Following testing, a technical file is compiled with your device’s design and manufacturing specifications, test results and risk assessments. This file is important for demonstrating that your device conforms to European requirements.
- Draft the Declaration of Conformity (DoC). After completing testing and compiling a technical file, a Declaration of Conformity is prepared. This document acts as an official statement that your device complies with all relevant EU directives.
- Affix the CE mark to your device. Once these steps are complete, you can place the CE mark on your device, allowing you to legally market it within the EU.
Is CE Certification a Self-Certification Process?
In certain cases, CE certification can be classified as a self-certification process. For products that fall under low-risk categories, you, as a manufacturer, are solely responsible for ensuring that your device complies with all applicable EU directives.
Once testing is completed, your company will draft a Declaration of Conformity to declare that your device meets the necessary safety, health and environmental requirements, then affix the CE mark to allow your device to enter the European Economic Area market.
For high-risk products, such as medical devices or complex electronic devices, third-party lab involvement is required for CE certification. This involves a Notified Body, an organization that has authorization from the EU to ensure devices meet all necessary standard.s
In the event that a device requires a Notified Body assessment, the CE mark will potentially be accompanied by an identification number associated with the body that conducted the device’s conformity assessment.
Our team can help you to understand the CE certification process for your device, including all key steps to achieve compliance, in more detail.
Contact Us About CE Testing and Certification
Completing the CE testing and certification process is critical if you intend to market your device in the European Economic Area.
As an ANSI-accredited electronics testing lab, we specialize in compliance testing for CE, FCC, ISED and other regulatory compliance marks. Our team can test your device and help you get the certifications you need for market access in Europe and other regions.
To request a free quote for testing and certifying for your device, or to ask our engineers your questions about the compliance process, contact us online or call us at info@hbcompliance.com, (480) 684-2969.