What are the Benefits and Harms of Self-Declaration Instead of CE Certificate?

Are you thinking of attaching the CE mark to the product as a first party and doing the CE certification yourself? Here’s what you need to know.

Before selling your product to the European Union economic market, it must obtain the CE certificate and affix the CE marking. A decision that manufacturers must make at the export stage is whether the CE conformity assessment of the product in question can be received by an independent organization as the first party or by a third party. We have compiled for you whether this method, called self-declaration, is really suitable for you and in what situations it would be practical to do it.

What is self-declaration (manufacturer’s declaration of conformity)?

As the name suggests, self-declaration means that you, as the manufacturer or importer, evaluate the conformity of your products in CE certification issues and make a conformity assessment, test the product according to the relevant regulations and standards, create a technical file, and if all of these are appropriate, issue a declaration of conformity and put the CE mark logo on your product. Includes attachment. Most manufacturers can add the CE mark based on their own internal controls rather than obtaining a CE certificate from a third-party notified body. The important thing to consider here is to be familiar with all technical specifications regarding the product and to carry out the testing and conformity assessment process correctly.

How do I get the CE Mark for my product?
Before you decide whether self-declaration is really the way you want to proceed, let’s review what it means to affix the CE marking to your product. According to the European Commission, manufacturers must follow these 6 steps:

• Identify applicable directive(s) and harmonized standards.
• Verify 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 check its suitability.
• Prepare the necessary technical file and keep it ready to present to the competent authorities when necessary.
• Paste the CE mark logo and issue the declaration of conformity

Can I Approve My Product Myself?
In most cases, if a conformity assessment by a notified body is not required, manufacturers can certify their products themselves (as long as they apply European harmonized standards during the conformity assessment). For example, electrical appliances, some pressure equipment, some construction materials, and most Class I non-sterile medical devices do not require a notified body. However, even determining whether a notified body is needed for the certification of machinery, electronic devices, medical devices or construction products is complicated. You can get free support from our ONE-CE technical team to determine which group your products are in.

Should I Approve My Product Myself?
CE marking self-declaration may be attractive to manufacturers who think they will avoid the additional costs of working with a third party. However, CE marking and CE certification directives and testing processes are notoriously complex. You need to consider the following steps for which you must take responsibility:

• Define the legal framework that applies to your product
• Determine what evaluations are required for your product
• Performing internal controls and performing tests appropriately.

These steps can be tedious and time-consuming, and time is of the essence once your product is ready for market access. Testing processes for electronics and machinery are complex, and not knowing which testing facilities are suitable can be a very expensive mistake. Our certification experts carry out a genuine CE marking and CE certification procedure specific to your product, ensuring compliance. They take 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.