How to Identify the Applicable CE Legislation and Conformity Assessment Process

Two important decisions determine how a CE marking project should be handled:

1. Which EU legislation applies to the product? 

2. Which conformity assessment procedure must be followed? 

A systematic approach helps ensure that both decisions are correct and properly documented.

Step 1: Understand the Product Completely

Before looking at any legislation, clearly describe the product, including:

• What the product does and how it operates 

• Its energy sources, such as electricity, battery, pneumatic, hydraulic or mechanical power 

• Whether it has moving parts and what hazards they may create 

• Whether it produces or may be affected by electromagnetic interference 

• Whether it has radio or wireless functions 

• The materials and substances used in the product 

• Whether it contains pressure vessels or pressure-related components 

• Where the product will be used, including potentially explosive environments 

• Who will use it, such as professionals, consumers or both 

• Its intended use and reasonably foreseeable misuse 

• Whether it is a complete product, partly completed machinery or a component 

Important: Many incorrect CE determinations happen because the product has not been described completely, rather than because the legislation was misunderstood.

Step 2: Check All Potentially Applicable Legislation

For each possible piece of legislation, check whether the product falls within its scope.

Use a checklist based on the product category rather than starting with the legislation you already know.

Some areas that are commonly overlooked include:

• Electromagnetic compatibility 

• Restrictions on hazardous substances 

• Radio equipment, especially when wireless connectivity is added later in product development 

Step 3: Check for Overlaps and Exclusions

Some legislation may exclude products that are covered by more specific legislation. In other cases, different legislation may apply to different aspects of the same product.

If several pieces of legislation apply, the product must meet the requirements of all applicable legislation, and the Declaration of Conformity should refer to them accordingly.

Step 4: Identify the Essential Requirements

Each applicable piece of legislation contains specific requirements that the product must meet. These are often listed in an annex.

These requirements are the actual legal obligations.

Harmonised standards can help demonstrate compliance, but they do not replace the need to understand and assess the legal requirements.

For each requirement:

• Record how the product meets it 

• Identify the standards or other methods used 

• If a requirement does not apply, record that it was considered and explain why it is not applicable 

Step 5: Select the Correct Conformity Assessment Procedure

The applicable legislation will specify which conformity assessment procedures are available.

The correct procedure depends on factors such as:

• The type of product 

• Its classification 

• Its risk level 

• The applicable legislation 

• In some cases, whether relevant harmonised standards have been fully applied 

The procedures can range from internal production control, where the manufacturer performs the assessment itself, to procedures involving a notified body for activities such as type examination, quality-system assessment or individual product assessment.

The higher the product risk, the more external assessment may be required.

Using self-declaration when a notified body is legally required can result in a serious non-conformity and make the CE marking invalid.

Step 6: Identify the Relevant Harmonised Standards

Harmonised standards referenced in the Official Journal of the European Union can provide a presumption of conformity for the requirements they cover.

When selecting a standard:

• Check that you are using the currently applicable version 

• Confirm that it is cited for the relevant legislation 

• Identify exactly which requirements it covers 

A single standard may not cover every applicable requirement.

If you do not use a relevant standard, or if you depart from it, you need to demonstrate conformity through another appropriate method and document the justification in the technical file.

Step 7: Plan Testing Based on the Requirements

Testing should be planned after you know:

• Which legal requirements apply 

• Which standards are relevant 

• What needs to be demonstrated 

Testing too early can result in testing the wrong characteristics or missing important requirements.

Step 8: Document the Decision

Keep a clear record of:

• Which legislation was considered 

• Which legislation applies and why 

• Which legislation does not apply and why 

• The conformity assessment procedure selected 

• The reason for selecting that procedure 

• The standards used 

• Any alternative methods used to demonstrate conformity 

This documentation shows that the CE assessment was carried out systematically.

It also makes it easier to reassess the product when its design, components, suppliers, intended use or applicable legislation changes.

Step 9: Define When the Assessment Must Be Reviewed

The CE assessment should be reviewed when there is:

• A significant product or design change 

• A change in components or suppliers 

• Entry into a new market 

• A change in intended use 

• A change in applicable legislation 

• A revision or replacement of relevant standards 

Common Mistakes

The most common weaknesses include:

1. Incomplete product description, resulting in applicable legislation being missed 

2. Checking only the most obvious legislation 

3. Selecting the conformity assessment procedure without checking the product's classification 

4. Using self-declaration when notified body involvement is required 

5. Referring to outdated or superseded standards 

6. Failing to assess each essential requirement individually 

7. Not documenting how the legislation and assessment route were determined 

8. Not reviewing the assessment when the product or regulatory requirements change