The starting point is identifying the European legislation relevant to your product. Depending on the product’s function, design, intended application, and risk profile, more than one directive or regulation may apply at the same time.

For example, an electronic industrial device with wireless capability may need to comply with several legal frameworks simultaneously.

After identifying the legal framework, the next task is selecting the harmonised European standards linked to those requirements.

These standards translate broad legal obligations into measurable technical specifications. Applying harmonised standards is not mandatory, but it is generally the most practical way to demonstrate conformity because they provide a recognized technical path to compliance.

These standards are developed by recognized European bodies such as:

• CEN 
• CENELEC 
• ETSI 

Depending on product risk, the manufacturer may follow either:

• Self-declaration of conformity, or 
• Third-party assessment by a Notified Body 

Risk assessment is a central element of CE compliance. It identifies possible hazards linked to the product and determines how those risks are controlled or reduced.

The risk review should cover all reasonably foreseeable conditions of use, including misuse where relevant.

Typical risk considerations include:

• Mechanical hazards 
• Electrical hazards 
• Thermal risks 
• Chemical exposure 
• Fire risks 
• Functional safety concerns 

This stage should be completed during product development, not after the product design is finalized.

The technical documentation file is the formal evidence showing how the product complies with applicable EU requirements.

It does not normally need to be submitted before market entry, but authorities may request it at any time after the product is placed on the market.

A standard technical file generally contains:

• Product description and intended use 
• Design drawings and technical specifications 
• Bills of materials and component details 
• Applied standards list 
• Risk assessment records 
• Laboratory test reports 
• User instructions and safety information 
• Manufacturing control information 

Once compliance has been demonstrated, the manufacturer must issue an EU Declaration of Conformity.

This document is the formal legal statement that the product satisfies all applicable European requirements.

It typically includes:

• Manufacturer name and address 
• Product identification details 
• Applicable directives and regulations 
• Applied harmonised standards 
• Declaration statement of compliance 
• Date and place of issue 
• Name and signature of the authorized representative or responsible signatory

After technical compliance has been completed and the declaration has been issued, the CE mark can be placed on the product.

The CE marking must be:

• Clearly visible 
• Legible 
• Permanently affixed where practicable 
• Applied in the prescribed proportions 

Where product size or design makes direct marking difficult, the CE mark may appear on packaging or accompanying documentation, depending on legal requirements.

Applying the CE mark means the manufacturer accepts full responsibility for the product’s compliance with applicable European legislation.