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CE marking, product safety and standards
Support with questions about CE marking, product safety and standards
Manufacturers, importers and distributors are responsible in different ways for the conformity of the products they supply with EU product safety regulations. Our CE consulting team offers you individual support for the implementation of your statutory obligations.
CE entry consulting.
Your compass for product safety.
If you develop, manufacture, import products into the EU or trade them on the EU market, they may require CE marking or fall under the General Product Safety Regulation (EU) 2023/988.
- Do you know about the legal requirements in the EU and their implementation?
- Have you taken the principles of product safety and CE marking into account when developing your product?
- Do you know about the legally required technical documentation?
We will answer your most important questions as part of a free initial consultation.
Our offer
"Which directives and regulations does my product fall under?"
Answering this question is one of the most important aspects for the design, development, marketing and import of products in the European Union. Products may only be placed on the EU market if they comply with all legislation applicable to the product.
We can help you find out which EU directives/regulations apply to your product - especially those that require the product to bear the CE marking.
"Does my product need a CE marking?"
EU product safety regulations define a range of requirements for the products they cover. However, only products that fall under a directive/regulation that explicitly requires this marking must and may bear a CE marking.
Central to the regulations are usually the so-called "essential (safety) requirements" or "protection objectives", i.e. technical and formal safety aspects that the products must comply with. It must be possible to demonstrate compliance with the protection objectives by means of product-specific technical documentation with legally prescribed content. For most directives/regulations requiring CE marking, a risk assessment of the product is also required.
In our initial consultation, we provide you with an overview of the safety aspects and documentation requirements for your product and also answer further questions, such as
- What other labeling does my product require?
- What is a risk assessment?
- Which technical standards are applicable to my product?
- Where can I find further information and the full texts of the directives and regulations?
- What is an EU declaration of conformity and what does it look like?
So-called "harmonized standards" are listed in the Official Journal of the European Commission and are intended to specify the legal requirements of EU directives and regulations in technical and product-specific terms. In order to comply with EU regulations, norms and industry-standard technical specifications and standards should therefore be used and taken into account as early as the product development stage.
We help you to understand the importance of standards for the safety of your products and to identify the first standards that are relevant for your product.
As an economic operator, i.e. a trader or company, you have a duty of care for the products you make available on the EU market. The scope of these obligations depends on what type of economic operator you are.
Many EU product safety regulations generally define five economic operators (manufacturer, importer, distributor, authorized representative, fulfilment service provider). It should be noted that you can be a different economic operator for different products that you make available on the market.
We support you in finding out what type of economic operator you are and what obligations this entails for you. For example, we can advise you on
- what due diligence obligations you have with regard to the conformity of the products you provide,
- which (technical) documents you must submit to a market surveillance authority on request,
- what evidence and declarations you should obtain from your suppliers and what obligations exist along the supply chain.
CE expert advice.
Services for the safety of your products.
For more in-depth consulting needs, we offer our expertise and active support on all topics relating to CE and product safety beyond initial consulting. From detailed expert advice on a specific topic to long-term support for an ambitious development project - contact us!
Our offer
Many questions about CE marking and product safety only arise during the implementation of legal requirements. Whether you have questions about the practical implementation of specific requirements, the need for in-depth research into standards or questions about foreseeable regulatory changes announced by the EU Commission: Feel free to contact us again after the initial consultation - we will be happy to help and advise you.
A frequent challenge in the construction, conversion and extension of machinery and systems is the assessment of whether it is a "substantial modification" or the construction of an "assembly of machinery" (colloquially also referred to as an "interlinked system" or "complex system"). Substantial modifications and assemblies of machinery require a full conformity assessment and a new CE marking - usually by the person or company carrying out the modification or extension.
We support you in the technical assessment of whether a project is a substantial modification or an assembly of machinery, and in the associated conformity assessment and documentation obligations.
Technical documentation is the most important evidence for market surveillance authorities to assess the conformity of products with legal requirements. Most EU regulations on product safety and CE marking require technical documentation to be submitted by certain economic operators at the request of an authority.
We support you in compiling the legally required documents - by drafting, creating and filling in samples, or with a document check of the documents you have prepared.
The risk assessment is usually an essential required component of the technical documentation and is subject to normative requirements in some directives/regulations, such as the ISO 12100 standard or CENELEC Guide 32. The risk assessment serves to systematically identify and reduce hazards posed by a product so that the protection objectives of the EU product regulations are met.
We support you in drafting the risk assessment or by checking your risk assessment against the requirements of relevant directives/regulations and standards.
The operating instructions are part of product safety - product manufacturers should therefore take particular care when drafting them. As with the risk assessment, there are both statutory and normative requirements for the design of operating/user instructions.
We check the instructions you have drafted for formal compliance with these requirements, in particular compliance with IEC/IEEE 82079-1 for technical and general consumer products and ISO 20607 for machinery.
With a few exceptions, every product subject to CE marking requires an EU declaration of conformity and prescribed traceability markings. Do you know where to find the relevant information and how to proceed if your product is covered by various directives and regulations?
We can help you draft or check your declaration of conformity and product labeling.
CE and product safety is not an issue that only affects individuals: from purchasing to research and development, design, quality assurance, after-sales service and management, a wide range of departments in a company are required to ensure product conformity.
We support you in integrating processes and work steps that are relevant to CE conformity and the safety of your products into your operational procedures, and help you to define responsibilities in your company and create awareness of legal requirements.
Whether in-house at your premises, virtually or as a guest speaker at your event: We offer you customized training courses, information events and seminars according to your needs. Benefit from our many years of experience as a speaker at certification courses on CE marking and product safety, as well as customer-specific in-house seminars!
Examples of seminars/training courses held:
- Basic seminar on CE marking and product safety
- Certificate course for CE representatives for machines and systems
- Practical seminar on the implementation of the new Machinery Regulation (EU) 2023/1230
- CE update training on annual innovations and developments
- CE seminar on the Low Voltage Directive/EMC Directive/Radio Equipment Directive/RoHS Directive
- CE seminar for toy safety specialists
- Overview of product safety requirements for managers
Contact us - we will design the right offer for you.
Your advantages
- Product and company-specific consulting services
- Support with the practical implementation of legal requirements
- Support in all development phases from the product idea to market launch and (series) production
- Permanent development of expertise in CE marking and product safety in your own company
* Consulting services of a maximum of two hours are free of charge for companies based in Bavaria that meet the definition of a small or medium-sized enterprise. For companies that do not meet the above criteria, a short, free orientation consultation is available with the non-binding option of a subsequent, fee-based consultation.
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