Products with the CE Mark can be sold in the European Union (EU) common market, which includes all EU member countries, plus several other countries that accept the equivalent of CE certification or have adopted the CE requirements themselves.
By affixing the CE Mark to a product, the manufacturer attests that it complies with all applicable regulations in the CE framework for safety, electromagnetic compatibility (EMC), environmental protection, radio usage, energy efficiency, and handling of hazardous materials.
Conforming with CE certification requirements
is mandatory for a wide range of products, including food products, medical
devices, WiFi and radio-enabled products, industrial equipment, containers for
hazardous materials, and more. Some of these products can use the
self-declaration route, like class I medical devices and machinery that is not
designated as high-risk. Other products need to work with a Notified Body to be
compliant, such as high-risk machinery, advanced medical devices, electrical
equipment, and containers for hazardous materials. These are two acceptable,
yet separate, ways of achieving CE certification for a product.
Self-Declaration vs. Notified Body
(Third-Party Approval)
Self-declaration means the manufacturer (or an authorized representative) is assessing the conformity of the products themselves. Self-declaration is an important part of the CE certification framework, and manufacturers of many types of products can take advantage of this self-directed approach. If regulators have questions or concerns about the safety or efficacy of the product in question once it’s on the market, it will be up to the manufacturer to demonstrate that their self-assessment is accurate and that the product performs in exactly the manner described in the self-declaration process.
However, some types of products—particularly products that carry a significant risk to the operator or general public if not properly designed, manufactured, and operated—still need to obtain a certificate from the third-party organization known as a Notified Body. A Notified Body is an organization that has been evaluated for competence and independence in CE conformity evaluations by the applicable EU member state. If the organization meets all competence and independence, it will be registered as a Notified Body in the NANDO information system and can be called upon to ensure conformity of products that cannot go the self-declaration route.
Steps for Self-Declaration
CE directives, testing requirements, and even determining whether or not a product can use the self-declaration process are all complex and highly variable based on the type of product. Consult a compliance professional if you are unsure whether self-declaration (or CE certification as a whole) is right for you.
That being said, the process of
self-declaration typically involves the following steps:
- Identifying the applicable standards and directives (and any product-specific requirements)
- Determining if a third-party assessment by a Notified Body is required
- Conducting a conformity assessment
- Preparing a technical file
- Issuing a declaration of conformity
- Affixing the CE Mark to your product
Learn More About Self-Declaration for the CE Mark
The compliance professionals at G&M Compliance can help you determine if your product needs CE certification, and if so, whether or not the self-declaration process will work for you. G&M Compliance can support the entire process, from the strategy for harmonized international standards to the logistics of product testing, and get your product to market.
Contact G&M Compliance today to get a
quote or learn more about the requirements of the CE Mark.