CE: „COMMUNAUTE EUROPEENNE“ OR JUST „CHINA EXPORT“?
tech-solute does not award CE marks. The CE mark is a declaration by the manufacturer – for which it is responsible – for market surveillance and consumers. It tells them that its products comply with all the European directives applicable to the products. We are happy to support you on your way there.
As a competent partner, we will help you acquire an overview about which standards are relevant to your product, and which quality requirements must be fulfilled in order to attain CE conformity. On request, we will work out suggestions for improvements and put your product through the required tests.
Conformity analysis: We will acquire the relevant standards for your product, and work out which requirements and specifications must absolutely be fulfilled for its technical implementation. Then we will investigate in detail whether your product (including circuits and software) is actually CE compliant. On request, we are happy to deliver suggestions for improvements at the same time.
Risk assessments (hazard analysis): As part of a hazard analysis /risk assessment, we will identify all the hazards and risks which may result from your device / machine. This assessment and evaluation is an ideal basis for the use of risk mitigation to reduce the hazards sufficiently – so that only an acceptable residual risk remains.
Device testing: We will put your product through the required tests for CE approval. Since these tests may be very diverse and require all kinds of measurement equipment (e.g. EMC, high-voltage, moisture, pressure), we will engage and coordinate with competent partners for the relevant tests. You receive all the results from a single source!
Documentation: We will inspect or create CE-compliant documentation for your product. This involves the preparation of the Declaration of Conformity, circuit diagrams, design drawings and the user information (labels on the device, display information and the instruction manual plus, if necessary, maintenance instructions including operating instructions).
We are happy to support you with the following six steps to acquire CE conformity, which are specified by the EU:
Step 1: Identify the valid directive(s) and harmonized standards for your product.
Step 2: Determine the specific conditions for your product.
Step 3: Determine whether a notified body must be involved in the conformity assessment procedure.
Step 4: Apply the CE marking to your product and write the EC Declaration of Conformity.
Step 5: Put together the required technical documentation and keep it ready for viewing.
Step 6: Validate the product and check the conformity.