European legislation requires certain products to have the CE mark before they can be sold in the European Economic Area (EEA). In order to obtain this mark, you must complete a conformity assessment procedure and demonstrate that your product meets all relevant requirements. It is important to understand the 8 types of conformity assessment procedures for CE marking and when each one is appropriate. This article describes the 8 available modules and explains how to determine which procedure you should follow.
What are the eight conformity assessment procedures?
The 8 available conformity assessment procedures are described in decision 768/2008/EC. Which procedure should be used for a specific product, depends on the risk and required safety level of that product. The relevant directives for a product describe which procedure(s) should be followed. The 8 conformity assessment modules are:
- Internal production control
- EC-type examination
- Conformity to type based on internal production control
- Conformity to type based on quality assurance of the production process
- Conformity to type based on product quality assurance
- Conformity to type based on product verification
- Conformity based on unit verification
- Conformity based on full quality assurance
How to choose the right conformity assessment procedure?
As CE marking is designed to be a self-certification process, and 95% of all products can be self-certified without the involvement of a notified body, for most products module A - internal production control is sufficient.
In case a notified body shall be involved, one of the other modules should be used, as determined by the relevant directives or regulations.
To identify which procedure applies to your product:
- Determine the directives and regulations that apply to your product (see this guide).
- Open each relevant directive or regulation (see this page of the EC).
- Press ctrl+f and search for “procedure for assessment of conformity” or related keywords.
- Determine the applicable procedure for your product.
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