Conformity assessment

Conformity assessment and pre-production risk management

Conformity assessment and pre-production risk management are designed for a manufacturer to check that their product complies with all applicable legislation and it is safe to offer for sale in the EU. It applies to products for which a CE marking is mandatory, which include for instance toys, electrical products and personal protective equipment.

Conformity assessment is the process which a manufacturer should follow to demonstrate that their product complies with all applicable legislation.

Conformity assessment is a process with six steps:

Identify the legislation and harmonised standards applicable to the product.
Verify the product-specific requirements.
Identify whether an independent conformity assessment is required from a Notified body.
Test the product and check its conformity to the EU legislation.
Draw up and keep available the required technical documentation.
Affix the CE mark to your product and EC Declaration of Conformity.

The process is by and large the same for all products, but there may be differences depending on the product type, which can be seen in the applicable legislation for specific products. As an example, it is mandatory for some product categories to involve a test laboratory in the conformity assessment (testing and/or production control).

Pre-production risk management

Pre-production risk management is a systematic assessment of all the risks that may be posed by hazards in the product to verify that they have been reduced to an acceptable level.

It is recommended that manufacturers use a table with three columns, like the one below:

The first column lists all the potential hazards.

The second column has an indication whether this hazard is relevant for the product.

The third column describes how it is measured if the risk has been adequately mitigated.

The manufacturer should work their way through the table line by line to check which of the hazards exist in the product. For each relevant hazard, the manufacturer should analyse how to measure if the risk has been adequately reduced. This is normally done by referring to a clause in a standard.

For most directives, the list of hazards in the first column of the table is identical to the essential health and safety requirements that is found in an annex to the directive.

For electrical products, it is recommended to use table D of Cenelec Guide 32

The General Product Safety Directive covers many different product groups. The European Commission provides guidance to standards of those products that are not covered by specific legislation at European level.

Example

An example showing the first column in the table for toys is set out below. The hazards or requirements in the first column are copied from the Toys Safety Directive, annex II. The items are numbered similar to the numbering in the annex.

Learn more about conformity assessments and how they work in practice

Learn more about the risk assessment for Safety Gate/RAPEX. It is an online tool that can be used for free on the Safety Gate website to estimate the level of risk for different categories of products. The tool follows the risk assessment guidelines laid down in Commission Implementing Decision (EU) 2019/417.

Conformity assessment process

Example – Pre-market risk assessment of a luminaire

You can learn more about this subject in the case studies section.