We advise and assist with risk assessment and the preparation of EC declarations of conformity.
We advise and assist with risk assessment and the preparation of EC declarations of conformity.
CE consulting – KERN assists with CE marking
In the European Economic Area (EEA), the CE marking is a mandatory quality mark for products sold within this economic area. The marking serves as an indicator that the relevant European directives have been complied with and that the essential requirements for safety, health protection and environmental protection have been met. The CE marking thus ensures that goods can be traded freely in EU member states without further national testing.
For companies that affix the CE marking to their products, the risk of legal consequences or import restrictions is minimised, as the marking documents their compliance with EU requirements. Particularly in the fields of technical documentation, mechanical engineering, medical devices and electrical appliances, CE marking is an essential element in enabling market access in Europe and strengthening consumer confidence.
Well advised with KERN when it comes to CE certification
CE marking is subject to a number of requirements and becomes a mammoth task without a process-oriented company organisation. This includes precise technical documentation, a detailed risk analysis and compliance with all relevant EU directives.
KERN also supports companies with CE certification at every stage of the process. The services range from analysing legal requirements to preparing the necessary documents. KERN has many years of experience and in-depth expertise. This enables the company to ensure that products pass all necessary tests and can be introduced to the European market in a legally compliant manner. Tailored advice and professional translations of technical documentation contribute to a smooth and efficient CE marking process and enable companies to focus on their core business.
Kindly note: our services relating to CE marking are currently only available in Germany and Austria.
CE consulting by KERN TecDoc
- Review and preparation of the risk assessment
- Review and preparation of the CE Declaration of Conformity and Declaration of Incorporation
- Workshops and webinars for CE conformity assessment procedures
- Introduction of and training on CE software
- Accompaniment and support in communication with notified bodies such as TÜV
- Research on standards, for example with regards to new products
- Review of product approvals, required documentation, documents such as EMC tests
- Review of market and target group requirements
- Support and optimisation of internal CE processes
- WEKA Manager
- SafeExpert
The following contact persons are responsible for creating documents and communicating with external parties during the product life cycle:
- CE coordinators
- Documentation managers
- Quality management
- Heads of design and development
We support our customers with approvals, tests and inspections of products, machines, etc. For example, when communicating with:
- TÜV Süd
- VDE
- VDI
- Test labs
- Dekra
- Bundesnetzagentur (Federal Network Agency)
- FDA (USA)
- BfArM (Federal Institute for Drugs and Medical Devices)
Furthermore, we can adapt the processes necessary for certification through the CE coordinator. Technical documentation is also important for preparing test certificates and performance certificates. This is where the necessary acceptance documents from the departments are collected and assessed.
CE marking in technical documentation
The CE marking serves as proof that a product complies with applicable EU directives and meets the necessary safety and health requirements. Comprehensive and accurate technical documentation is essential in this regard, as it forms the basis for the CE declaration of conformity and the CE marking.
KERN TecDoc supports companies in the creation and translation of this technical documentation. Through precise and standards-compliant translations, we ensure that all relevant documents are available and accurate in the respective national languages. This is particularly important in order to affix the CE marking in a legally compliant manner and thus enable market approval in the EU.
Rely on CE consulting from experienced experts. Put your trust in KERN TecDoc.
Information sheet on CE marking
- Does my product require CE marking?
- Am I responsible for CE marking?
- Which EU directives apply to my product?
Frequently asked questions about CE marking
Is the CE marking a seal of quality?
The CE marking does not function as a seal of quality or a test mark. It merely serves as an indicator that the product complies with the EU’s basic safety, health and environmental requirements.
Who is responsible for CE marking?
The responsibility for affixing the CE marking lies with the manufacturer or its authorised representative within the EU. It is his responsibility to ensure compliance with all relevant requirements and to issue the necessary declaration of conformity.
What penalties apply for missing or incorrect CE marking?
Products without a valid CE marking that are subject to mandatory marking may not be sold in the EU. This may result in fines, distribution bans or product recalls.
What is CE certification?
CE certification is a process that ensures that a product meets the requirements of the relevant EU directives. This includes tests, technical documentation and, where applicable, verification by a notified body.
Do I need an external certification body for CE marking?
In many cases, it is possible for the manufacturer to carry out the conformity assessment themselves. However, there are some product groups that must be tested and certified by a notified body. These include, for example, medical devices and pressure equipment.
How does the CE certification process work?
The process involves several steps:
- Identification of relevant EU directives and standards
- Conducting a risk analysis and conformity assessment
- Preparation of technical documentation
- Signing of the declaration of conformity
- Affixing the CE marking
How long does CE certification take?
The duration of the process varies depending on the product type and the specific certification process. A simple conformity assessment may take a few weeks, while an external audit by a notified body may take several months.
Is CE certification valid worldwide?
The CE marking is a specific requirement of the European Union. Other markets, such as the USA or China, have their own conformity requirements.