Are you considering affixing the CE mark to the product yourself as the first party and conducting CE certification on your own? Here’s what you need to know.
Before selling your product in the European Union’s single market, you must obtain the CE certificate and affix the CE mark. Manufacturers must decide whether to conduct the CE conformity assessment for the product in question themselves as the first party or have it carried out by an independent third-party organization during the export phase. We have compiled information on whether this method, known as self-declaration, is really suitable for you and in which cases it is practical.
What is self-declaration (manufacturer’s declaration of conformity)?
As the name suggests, self-declaration is a method of CE certification in which you, as the manufacturer or importer, assess the conformity of your products and undertake to carry out conformity assessment, conducting tests on the product in accordance with relevant regulations and standards, creating a technical file, and, if everything is in order, publishing a declaration of conformity and affixing the CE mark logo to your product. Many manufacturers choose to add the CE mark based on their own internal controls rather than obtaining a CE certificate from a third-party accredited body. The important thing to note here is to be familiar with all technical specifications related to the product and to be able to perform the testing and conformity assessment correctly.
How do I obtain the CE mark for my product?
Before deciding whether self-declaration is really the way forward, let’s review what it means to affix the CE mark to your product. According to the European Commission, manufacturers must follow these six steps:
- Identify the applicable directive(s) and harmonized standards.
- Verify the product-specific requirements.
- Determine whether an independent conformity assessment (by a notified body) is required.
- Test the product with appropriate and calibrated test equipment and verify its conformity.
- Prepare the required technical file and keep it available for submission to the competent authorities when required.
- Affix the CE marking logo and draw up the declaration of conformity.
Can I self-certify my product?
In most cases, if a conformity assessment by a notified body is not required, manufacturers can self-certify their products (provided they apply European harmonized standards during the conformity assessment). For example, electrical appliances, certain pressure equipment, some construction materials, and most Class I non-sterile medical devices do not require a notified body. However, determining whether certification by a notified body is required for machines, electronic devices, medical devices, or construction products can be complex. You can get free support from our TESTPLUS technical team to determine which group your products fall into.
Should I Self-Certify My Product?
The CE mark under the self-declaration method may be attractive to manufacturers who wish to avoid the additional costs of working with a third party. However, CE marking and CE certification directives and testing processes are, as everyone knows, quite complex. You must consider the following steps for which you are responsible:
- Identify the applicable legal framework for your product
- Determine which assessments are required for your product
- Carry out internal controls and perform tests appropriately.
These steps can be tedious and time-consuming, and time is of the essence when your product is ready to enter the market. Testing processes for electronics and machinery are complex, and not knowing which testing facilities are appropriate can be a costly mistake.
Our certification experts carry out a genuine CE marking and CE certification procedure that is tailored to your product and guarantees compliance. They take care of the necessary steps to ensure the quality and safety of your product while you focus on other matters. Therefore, if you want your product to enter the market before your competitors, it is best to work with a third party for a comprehensive and efficient certification process.
How Can a Third-Party Notified Body Help?
Companies with expertise in certification and testing can save you time by handling CE certification and affixing the CE mark for you. They also eliminate the possibility of penalties and other complications if your product does not meet the requirements of the relevant standards.
Third parties ensure an efficient CE certification process by providing the following:
- Expertise in certification and knowledge of standards
- Proficiency in technical record keeping
- Knowledge of CE marking and CE certification timelines
- Ability to decipher technical language in documentation
- Guaranteed fast market access
- Awareness of the importance of product compliance
What are the benefits of a third-party CE certification body?
As a manufacturer, it is your responsibility to ensure that your product meets EU safety requirements before placing it on the market. It is your decision whether to do this on your own or with the involvement of a third party. However, CE certification is a time-consuming and complex process. Ensuring that your product complies with technical compliance standards and regulations is crucial for the safety of future users and to avoid liability as a manufacturer. Working with experts in this field saves you time and energy when launching a product.
Do you have questions about the CE mark or CE certification? We’re here to help. Whether you’re new to the world of product CE certification or have questions about a specific part of the process, contact us to obtain your product’s CE mark and CE certificate quickly, accurately, and efficiently.
