Achieve your market access goals with Element, a leading provider of testing for electrical and mechanical devices. Our CE marking services go beyond compliance, seamlessly combining testing, certification, and documentation review into a single, efficient program, saving you time and money while ensuring your goods meet the requirements for sale within the European Union.

 

What is CE marking and what are the testing requirements?

CE marking is a compulsory EU conformity label that allows for the free movement of goods. Products that carry a CE mark are authorized for sale across all EU Member States, without additional technical or regulatory constraints. As such, CE marking  is a necessary passport to trade if you want your product to be available in the European Union. The requirements for CE marking are dictated by EU legislation, typically directives or regulations approved by the European Commission, and then integrated into the laws of each Member State. These include 'essential requirements' or core compliance points, differing for each product category, which must be met before a product can be CE marked. Conformity to the essential requirements can be validated by testing, which facilitates certification where required. They also provide ‘minimum requirements’ with technical details outlined in harmonized standards which can be adjusted by individual states so long as the core requirements remain the same.

Determining which legislation applies to your product, and which requirements are ‘essential’ or ‘minimum’ can be challenging without the guidance of an expert, as most directives and regulations are written in legal or technical terms rather than approachable language. Element’s experts can help identify the correct requirements for you and guide you through any necessary risk assessment before further testing begins.

 

Key benefits of CE marking services with Element 

  • Comprehensive regulatory support: As CE marking service providers, our team can help you understand and comply with specific requirements, ensuring you stay updated on regulatory changes and adapt your product to new requirements. We can also provide tailored strategies for diverse products and markets.
  • Assistance with technical documentation: Our experts carefully prepare the required technical documentation, ensuring it aligns with required standards and regulatory criteria. From compiling essential information to showcasing conformity, we streamline your documentation process, providing a smoother CE marking experience for your products.
  • Interpretation of applicable standards: Our team at Element can help you identify the relevant directives and standards applicable to your products. We ensure an accurate understanding and application of these requirements to help prevent mistakes and delays.
  • Supporting Supply Chain Compliance: Element can help you be certain that each component in your product's supply chain complies with the necessary standards. We can implement strategies to manage and monitor the compliance of the entire supply chain through regular testing and auditing.
  • Ensuring Global Market Access: Through correct, compliant CE marking you will gain access to trade your product in all EU Member states without additional technical or regulatory requirements. Not only can Element help you access these markets faster, more reliably, and with greater assurance for your customers, but you can also reduce your environmental impact by reducing the number of touchpoints needed for trade. 
James Daniels is an CE Mark Testing Expert

James Daniels

General Manager of Element’s Connected Technologies business in the UK

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Jakucki

MacieJ Jakucki

Division Director for Medical Devices

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Streamlining Your Compliance Journey

Getting a product through the CE marking process can be challenging and we know you want to avoid project delays. Our CE marking experts help streamline the entire process, by project managing the end-to-end solution from testing to certification and meticulous documentation review. With a dedicated team focused on establishing realistic timelines aligned with your project goals, we optimize efficiency at every stage of the CE marking process. Our emphasis on efficient project management ensures timely compliance and contributes to a cost-effective service, saving your business valuable resources. Proactively addressing regulatory challenges, we aim to prevent last-minute hurdles that could lead to delays, allowing your compliance journey to proceed smoothly. We are also able to combine third-party environmental testing to support your risk assessment and identification of hazards – saving you even more time and money by combining your tests into a single program. 

 

Helping you to understand the CE marking process

While the 8-step CE marking process may seem complex, our experts bridge the knowledge gap, guiding you at every stage from identifying requirements to maintenance testing. The CE marking process is as follows:

  • Determining the requirements
  • Identifying the appropriate standards (includes involving a Notified Body as needed and creating a test plan)
  • Performing the testing / applying the standards
  • Compiling technical information (includes completing a Notified Body review, if needed, and issuing a Statement of Opinion (SoO) if required)
  • Generating a Declaration of Conformity (DoC)
  • Affixing the CE Marking on products/equipment
  • Placing equipment on the market (putting the product into service)
  • Maintaining compliance through regular testing and auditing

If you need guidance tailored to your business, Element’s CE Marking Training courses, led by seasoned experts, offer flexible packages to address your questions and provide best practice guidance.

 

Our CE marking Å·ÃÀÊìÅ®ÂÒÂ× 

Our experts support every aspect of the CE marking process, helping you gain compliance. Our Å·ÃÀÊìÅ®ÂÒÂ× include:

 

Why Choose Element?

As a leading provider of testing on electronic and mechanical devices, Element is an obvious choice as your CE marking partner. Our expert reputation is evidenced by the fact we provide Notified Body services for multiple CE Marking Directives including The Radio Equipment Directive, the EMC Directive, and the ATEX Directive for Explosive Atmospheres. 
With this wealth of international industry-specific expertise, we can guide you through the complexities of CE marking, offering compliance assistance, robust risk assessment support, guidance through the 8-step CE marking process, unique testing programs, and global market access support. We are also in a unique position to combine not only testing, certification, and reviews – but also environmental testing and risk assessment with your CE marking services, providing a truly cost-efficient and streamlined solution. 
To discuss your CE marking requirements or questions, please contact us today – or learn more about Element’s credentials.
 

 

“CE EMC testing is not only the best way to determine compliance with the EMC directive, it also provides manufacturers with the confidence they need that their product will not cause interference or be affected by disturbances that are commonly experienced when they are used by customers. Manufacturers need their products to be robust and reliable to ensure their products’ good reputation, and this can only realistically be attained through EMC testing. ”

James Daniels

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Matter Smart Home Standard
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Matter Smart Home Standard

Element are one of the few test laboratories globally who can provide pre-testing and, when released, will provide formal testing to the new Matter smart home standards to enable manufacturers to gain certification through the CSA. Visit our service page for further information on the Matter smart home standard.

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