The first step: to determine the product in line with the directives and harmonized standards
More than 20 directives cover the products need to be affixed with the CE marking. Each of these directives covers a different range of products, and the directives list the basic requirements for the products they cover. An EU harmonized standard is a detailed technical document used to guide a product to meet the basic requirements of a directive.
Step 2: Determine the detailed requirements that your product should meet
You must ensure that your product meets the essential requirements of the relevant EU legislation. A product is considered to meet the relevant essential requirements only if it meets the requirements of all the harmonized standards to which it applies. The application of harmonized standards is entirely voluntary and you may choose to meet the respective essential requirements in other ways.
Step 3: Determine if your product requires a Notified Body
Each of the directives that your product is subject to has detailed rules on whether or not a third-party Notified Body is required to participate in a CE audit. Not all products are mandated to be certified by a Notified Body, so it is important to determine if you really need a Notified Body. These Notified Bodies are authorized by the European Commission and are listed in detail in the NANDO (New Approach Directive Notified Bodies and Designated Authorities) dossier.
Step 4: Test the product and check compliance
It is the manufacturer's responsibility to test the product and check its compliance with the EU regulations (conformity assessment process). Risk assessment is the basic rule in the assessment process, and meeting the requirements of the EU harmonized standards will make it possible for you to meet the basic requirements of the official EU regulations.
Step 5: Draft and save the technical documentation required by the Directive
Manufacturers must establish the product's technical documentation (TCF) in accordance with the requirements of the Directive to which the product conforms and the needs of the risk assessment. If required by the relevant authorizing authority, the manufacturer must submit the TCF together with the EC Declaration of Conformity for inspection.
Step 6: Put the CE marking on your product and make the EC Declaration of Conformity
The CE marking must be put on the product by the manufacturer or its authorized representative, and the CE marking must be clearly and permanently affixed to the product or its nameplate in accordance with its standard drawings. If a notified body is involved in the certification of the product, the CE marking must bear the notified number of the notified body. The manufacturer is obliged to draw up an EC Declaration of Conformity and to sign it to certify that the product meets the CE requirements.
After these six steps, your CE-marked products can circulate smoothly in the European market.