Conformity Assessment

Definition and context

Conformity assessment is the process that a manufacturer must follow to in order to have evidence that his product complies with all applicable EU legislation. The process applies to all products, both products that must be CE-marked and products where it is illegal to affix the CE mark. This fact sheet provides an overview of the entire conformity assessment process and is supplemented by further fact sheets which provide more detail on each step.

Method

The conformity assessment process has six steps:

1. Identify the applicable directives.
2. Identify whether there are any harmonised standards that apply to the product.
3. Carry out the pre-production risk management to ensure that all hazards in the product are adequately dealt with.
4. Test the product.
5. Compile the technical file.
6. If the product has to be CE-marked, then an EU declaration of conformity must be drawn up and the CE mark must be affixed. 

The activities to be undertaken in each of these stages are described below.

Identify applicable directives

• Go to the list of directives to check which apply
• Check the product definitions in the directives. They provide the scope of the controls.
• Identify those that might be relevant to the product.

Be aware that several directives may apply to a product. This is for instance always the case for electrical products and for electrical toys.

Identify applicable harmonised standards

Do the following for each of the applicable directives:

• Look up the directives on the list with directives.
• Click on the link and go to the homepage of each of the directives.
• Scroll to the bottom of the page where the following is stated “Summary list of titles and references of harmonised standards”.
• Open the summary list in the format you prefer (pdf or xls).

Multiple standards may apply to the same product if a single standard does not address all relevant essential requirements.

Note: The full text of European standards can only be purchased from a national standardisation body. The following site of CEN (the European standardisation organisation) provides links to the national standardisations’ bodies’ websites. In addition, the China Standards Information Services Network can be used to access European standards.

Carry out the pre-production risk management

Guidance on how to do this is given in the factsheet on risk management.

Test the product

The product is tested to verify that it passes all tests that were identified in the pre-market risk management. See the factsheet on testing. 

Compile the technical documentation

Guidance on how to do this is given in the factsheet on the technical file. 

CE marking

If the product has to be CE-marked, then the manufacturer must affix draw up and sign an EU declaration of conformity and affix the CE mark to the product.

The EU declaration of conformity is described in a separate factsheet.

The CE mark and the principles for its affixing to a product are described in detail in the factsheet on CE marking. 

Guidance

• Guidance on CE marking for professionals
• The ‘Blue Guide‘ on the implementation of EU product rules 2020

Related topics

• CE marking
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate / RAPEX
• Selling online
• Technical file
• Testing
• Using a third party

You may also visit the SPEAC ACADEMY to learn more about the EU Safety requirements.