Conformity Assessment Procedures And How To Choose The Right One

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: 

1. Internal production control
2. EC-type examination
3. Conformity to type based on internal production control
4. Conformity to type based on quality assurance of the production process
5. Conformity to type based on product quality assurance
6. Conformity to type based on product verification
7. Conformity based on unit verification
8. 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:

1. Determine the directives and regulations that apply to your product (see this guide).
2. Open each relevant directive or regulation (see this page of the EC).
3. Press ctrl+f and search for “procedure for assessment of conformity” or related keywords. 
   
4. Determine the applicable procedure for your product.