Europe is one of the world’s largest markets for electronic products, and many companies benefit from ensuring that their products are compliant with EU regulations. These include REACH, RoHS, and EMC regulations, as well as other product-specific or industry-specific regulations. To indicate compliance with EMC regulations, PCBs can be labeled with the CE marking, which stands for Conformité Européenne.
Many products sold in the European Economic Area (EEA) will require this marking as a demonstration of compliance with EU regulations. Manufacturers are responsible for carrying out compliance testing and issuing a declaration of conformity. Many products require a CE marking, including personal electronic devices, appliances, and medical devices.
For electronics, one of the most important requirements for obtaining a CE marking is EMC testing under applicable EU directives. In this article, we’ll look at the relevant requirements for demonstrating compliance and legally applying the marking to a product.
The Process for Obtaining a CE Marking for Electronics
Electronic products must comply with a range of standards, including those associated with EMC, RoHS, and REACH. There may also be regional standards that apply to particular products. One of the greatest obstacles to obtaining a CE marking is EMC compliance. At a high level, the process of demonstrating compliance involves four stages; these are discussed in the sections that follow.
Identifying Applicable EMC Standards
As a first step, it’s important to understand the performance and testing standards that apply to your product. You will need to determine if your product falls under relevant EMC directives. Some common directives are listed below.
- EMC Directive (2014/30/EU)
- Low Voltage Directive (LVD) (2014/35/EU)
- Radio Equipment Directive (RED) (2014/53/EU)
- Automotive EMC Directive (95/54/EC)
- Machinery Directive (2006/42/EU)
- Medical Device Regulation ((EU) 2017/745)
The EU also maintains a list of harmonized standards that provide a "presumption of conformity" with the essential requirements in the EMC Directive. To learn more and identify harmonized standards that may apply to your product, visit this page provided by the European Commission.
Performing EMC Testing
Once the applicable standards are identified, the product must be tested for emissions and immunity. These tests are based on specific test cases outlined in the relevant standards and are often performed by a certified laboratory. Testing may include but is not limited to
- radiated emissions testing,
- conducted emissions testing,
- ESD withstand testing,
- susceptibility (immunity) testing, and
- voltage/current surge testing.
This applies to products seeking the CE marking as well as products destined for other markets where similar standards are applicable, such as the United States or Canada. For EU products, the assessment should align with the essential requirements outlined in Annex I of the EMC Directive.
Although self-testing is permissible for some products, companies should contract with an accredited EMC test lab to ensure that the results are accurate. EMC testing requires specialized equipment and expertise that many companies do not possess. Furthermore, test labs can sometimes quickly identify the source of emissions failures, and this can make the redesign process faster and more efficient.
Compiling and Maintaining a Technical File
Companies whose products are required to conform to EMC standards will be responsible for compiling and maintaining a set of technical documents related to the design and performance of their products. This documentation is referred to as a product’s technical file, and it should contain the following information:
- A detailed description of the product, such as a user manual
- Technical design and manufacturing drawings
- EMC test reports and relevant data proving conformity with applicable standards
- Any relevant risk assessment studies and mitigation measures
When more than one EU directive is relevant for a product, the technical file should include the relevant documentation for all the applicable directives. In addition to EMC data, the technical file can also include documentation proving compliance with other regulations, such as REACH. The technical file must be retained for at least 10 years after the product is released to the market.
Creating a Declaration of Conformity
Once the product has passed testing and all necessary documentation has been added to the technical file, the company can generate a Declaration of Conformity. This document is a self-issued certificate attesting that the product complies with the relevant EU directives and standards. The certificate should include the following:
- Manufacturer’s name and address
- Product description and clear identification
- List of applicable directives and standards
- Date of issuance
- Location of issuance
- Signature of an authorized person or representative
The Declaration of Conformity is a legal document that in some cases must be provided with the product. Note that importers of products are seen as being legally equivalent to a manufacturer; thus, an importer of a product from an overseas vendor has full responsibility for the product’s compliance and must produce a Declaration of Conformity.
Placing the CE Marking
Finally, a CE marking must be placed on the product. For electronics, the CE marking can be placed on the PCB or on the product packaging. The marking must be clearly visible with a minimum height of 5 mm.
CE marking placed on the silkscreen layer of a PCB
An important part of achieving compliance in the electronics design process is performing pre-compliance, simulating to identify EMI sources, and completing the formal certification testing. To help reduce the number of prototyping and testing cycles, AI-driven simulation tools like those offered by DENPAFLUX can help designers pinpoint EMI sources in a PCB layout and narrow the search for the root cause of EMC failures. Contact us today to see how DENPAFLUX can shorten your journey to CE compliance.
