Ensure CE conformity

The European Union sets specific requirements for product safety. With the CE mark, the manufacturer or distributor declares on his own responsibility to the market surveillance authorities and consumers, according to EU Regulation 765/2008, “that the developed product complies with the applicable requirements laid down in the Community harmonisation legislation concerning their affixation”, i.e. that his product is in conformity with all European directives applicable to the product. The affixing of the CE mark is not voluntary. Every manufacturer, importer or trader must check for each product whether there is a labelling obligation and what obligations or risks arise for him as a result.

CE marking and the associated required conformity assessment procedure should be taken very seriously. In the event of damage, complete proof of the obligations associated with the labelling is required. We are happy to support you in ensuring the EU conformity of your product and documenting this in accordance with the regulations. The following overview shows the required steps.

1. Intended use
   Together we determine the intended use of your product and the groups of people who will later handle it.
2. Determine CE guidelines
   We identify the relevant CE directives for your product and the consequences thereof. Furthermore, we identify additional requirements or concrete options in the country of operation (so-called “transposition into national law”).
3. Research harmonised standards
   We determine whether so-called harmonised standards exist that are applicable to your product.
4. Requirements and conditionsn
   We determine which specific requirements and conditions are derived from the standards for your product.
5. Notified authority
   Whether it is mandatory or not to involve a “Notified authority” such as a testing laboratory or another authorised third party in the conformity assessment procedure, we clarify in this step.
6. Conformity assessment procedure
   In a hazard analysis or risk assessment, we gain knowledge about the hazard groups relevant to your product, the consequences thereof, the origins and the locations of the hazards. We determine necessary protective measures and assess whether the risk is eliminated or minimised to a sufficient degree.
7. Technical documentation
   We prepare the technical documentation for your product in accordance with EU requirements, including operating instructions, instructions for use, assembly instructions if applicable, EC type-examination certificate, circuit diagram, etc. We also supply the necessary translations for the countries in which the product is used.
8. EU Declaration of conformity
   We draw up the declaration of conformity, which you as the manufacturer or distributor only have to sign.
9. CE marking
   You may now affix the CE mark to your product, including the identification number of the Notified Body (if this was required), e.g. as an imprint on the type plate.
10. Observation of the legal regulations and the state-of-the-art technology
    As a result of previously unknown or identified risks, re-testing, rework and new certifications may become necessary for your product. On request, we regularly check whether there are any changes to the standards and directives relevant to you and how the technology is currently developing.