Without an official document, the product will not be allowed for sale, and all development and production costs may be wasted. Therefore, a correct understanding of the CE marking procedure is not just a technical requirement, but a strategic step for business development.
Step 1: Identification of directives and standards
The first thing to do is to understand what directives your equipment falls under:
- Machinery Directive (2006/42/EC)
- Low Voltage Directive (2014/35/EU)
- Electromagnetic Compatibility Directive (2014/30/EU)
- Other specialized regulations
Study the texts of the directives on the official website of the European Commission or on regulatory platforms. This step forms the basis for all subsequent actions and helps to clearly outline the list of mandatory tests and procedures.
For convenience, many companies choose to order CE marking from specialized consultants who help to properly match products to the necessary regulations.
Step 2: Preparation of technical documentation
Technical documentation is the heart of the certification process. It should include:
- Description of the purpose and technical characteristics of the equipment
- Complete lists of used parts and materials with supplier data
- Drawings, diagrams, installation and operating instructions
- Risk analysis according to EN ISO 12100
- Internal test reports
Competent collection and execution of these documents accelerates the obtaining of CE-marking and minimizes the risks of returning the package for revision.
Step 3: Selecting a conformity assessment scheme
Depending on the equipment category and hazard level, one of two basic schemes is used:
- Self-declaration (Module A) – suitable for low-risk devices. After internal testing, you draw up a declaration of conformity and mark the product with the CE mark.
- The involvement of a notified body (Modules B-H) is mandatory for complex and high-risk machines. The body performs a production audit and part of the testing, which confirms the objectivity of the assessment.
If you plan to order CE-marking in Kyiv, please contact centers with accreditation in the EU and experience in working with domestic manufacturers.
Step 4: Conducting tests in accredited laboratories
Regardless of the scheme chosen, a number of tests are mandatory:
- Electrical safety (IEC 60950, IEC 62368)
- Electromagnetic compatibility (EN 61000-6-3, EN 61000-6-1)
- Climatic and vibration tests
- Noise and mechanical tests
It is important to plan ahead for testing, as waiting lists at labs can be several weeks long. Distributing samples between different centers will help optimize the cost of CE marking and reduce the overall project time.
Step 5: Drawing up the declaration and affixing the mark
After positive test results and a successful audit, a Declaration of Conformity is drawn up, in which the manufacturer confirms that the equipment complies with all applicable directives. The document is signed by the responsible person and kept together with the technical file.
The final step is the application of the CE mark on the product body, its packaging and in the operating instructions. The mark must meet the requirements in terms of size, color and contrast and be resistant to the conditions of use.
Conclusions and recommendations
- Ordering CE marking for products at the design stage avoids pre-certification revisions.
- Timely regulatory review helps to keep in mind the latest updates to the directives.
- A centralized document registry with versions and signatures ensures package integrity.
- Hiring professionals from Standards & Quality helps you get through all five steps quickly and get CE marking for your products without surprises.
