CE Certificate

HOW TO OBTAIN A CE CERTIFICATE?

Before a product is placed on the market, all required procedures—such as testing, inspection, and/or CE certification—must be completed according to the applicable conformity assessment modules. Manufacturers must identify the EU directives and regulations applicable to their products and, if required, apply to a Notified Body authorized to perform conformity assessment.

The CE marking must follow the official proportions shown below. Although its size may vary, the ratio must remain unchanged. The CE marking must be affixed visibly, legibly, and indelibly to the product’s nameplate/label. If the nature of the product makes this impossible, the CE marking may be placed on the packaging or accompanying documentation.

ESSENTIAL REQUIREMENTS

A key characteristic of EU directives is that they define only the essential health and safety requirements for products that will bear the CE marking. Essential requirements refer to the inherent risks associated with a product. Therefore, if harmonized standards do not cover certain risks, manufacturers must perform a risk analysis and keep it inside the technical documentation.

While essential requirements describe the outcomes that must be achieved or the hazards to be eliminated, they do not prescribe specific technical solutions. Manufacturers can achieve compliance by applying relevant harmonized standards or specifications.

WHAT SHOULD THE TECHNICAL FILE (TECHNICAL DOCUMENTATION) INCLUDE?

EU harmonized directives require manufacturers to prepare a technical file that proves product conformity with essential requirements. This file must be kept for 10 years. The technical file is the responsibility of the manufacturer or authorized representative and may form part of the documentation of a quality system when assessment is based on quality assurance modules.

Although each directive specifies the required content in detail, a technical file generally includes:

• Product identification
• Intended use
• Design and manufacturing information
• Technical drawings and specifications
• Risk assessments
• Test reports
• User manuals
• Details of applied harmonized standards

You can access more detailed information on our website.

CE MARKING & CONFORMITY ASSESSMENT MODULES

Conformity assessment modules cover design, production, or both stages. Some modules apply only to design or production, while others cover both processes. There are eight main categories of conformity assessment modules:

Module A, A1, A2 – Internal production control

Module B – EU-type examination

Module C, C1, C2 – Conformity to type based on internal production control

Module D, D1 – Conformity to type based on production quality assurance

Module E, E1 – Conformity to type based on product quality assurance

Module F, F1 – Conformity to type based on product verification

Module G – Conformity based on unit verification

Module H, H1 – Conformity based on full quality assurance