In order to be sold in the European Union, a product must comply with EU health and safety standards. The CE mark indicates that a product meets all relevant standards for health and safety and that it can therefore be sold in the EU. For over 25 years, Certification Experts has ensured quick market access for products that meet the highest safety standards. Here’s how we provide tailor-made solutions throughout the 5 steps of the certification process:
Step 1: We will analyze the product’s characteristics and identify the relevant safety requirements. The path to certification is different for every product. Understanding which standards apply can be time-consuming and complicated if you are not familiar with the legal frameworks.
Working with us will spare you time and ensure your product meets the highest safety standard. We will prepare a complete framework of relevant requirements and a strategy for compliance.
Step 2: The safety of your product is largely determined by its design. In many cases, products already meet some safety standards due to their design or the use of components that are already CE marked.
To check if your product meets the necessary requirements, we screen the level of compliance, identify the gaps, and carry out testing if necessary. The ‘gaps’ refer to the standards which are not inherently met due to the product’s design. If your product requires testing, our experts are ready to assist with on-site or virtual testing.
Step 3: The documents in your technical file are determined by the legislation that your product must meet. Every piece of legislation has its own set of requirements for the technical file, from the type of documents to which information it contains.
We analyze which documents are needed in your file and write up the technical documents. Whether your file needs to be written from scratch or you have a specific question concerning the final touches, we will write or review your documents to ensure your technical file is complete.
Step 4: At this point, you have already determined that your product complies with all relevant safety requirements, and you may now legally affix the CE mark on your product.
The Declaration of Conformity (DoC) is the document in which you formally declare that your product complies with all relevant safety standards. We draft the Declaration of Conformity, compile a verified technical file, and deliver a conclusive expertise report specifically for your product.
Step 5: After you have applied the CE mark and drafted the declaration of conformity, the certification process is complete and you are ready for the fifth and final step: selling your product on the European market.
However, selling your product within the EU, the world’s largest trading block, includes important aspects that can be overlooked by manufacturers. Your technical file needs to be kept available for at least 10 years. If your business is not established within the EU, you need an Authorized Representative to sell your products in Europe.
We help you complete the certification process by identifying whether you need an AR, preparing the necessary documents and ensuring that your files are up to date. That way you can launch your product without having to worry about any unforeseen obstacles.
By guiding you through each step of the process, we help you to make sure your product complies with all relevant European directives and regulations so that your product is ready to be traded in the European Union. To read more about CE marking, click here.