EU Product Compliance Guidance – CE Marking
Customer safety is primary priority and, as a seller, you must take care that the products you supply are not only safe but also compliant with the relevant regulations.
This page provides guidance on existing requirements for CE marked products to help you understand how to sell these products compliantly in the EU. This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your products.
What is CE Marking?
The CE mark is a self-certification mark applied to a product by the manufacturer. The CE mark indicates that the product meets health, safety, and environmental protection standards for the European Economic Area (EEA). In addition, EU legislation requires that the manufacturer of a CE marked product issues an EU Declaration of Conformity for the product and draw up technical documentation (discussed in further detail below).
Not all products sold in the EEA are required to be CE marked. Common examples of products that are required to be CE marked include toys, electronics, personal protective equipment, machinery, construction products, gas appliances, recreational and personal watercraft, pressure vessels, and measuring equipment.
You can find a full list of the products subject to CE marking, as well information on the steps a manufacturer needs to take to affix the CE mark here:
What does CE marking legislation mean for me?
You must make sure that the products you sell meet the CE marking rules. To do so, we recommend that you do the following (with the help of your legal counsel, if needed):
- Confirm whether the products you sell require a CE mark..
- For products that require a CE mark, work with your upstream supplier to ensure that:
- The manufacturer has affixed the CE mark and all other relevant compliance markings to the product (or, in some circumstances, the packaging or accompanying documentation); and
- The manufacturer has issued a valid EU Declaration of Conformity (or Declaration of Performance for construction products) and drawn up additional applicable compliance documentation that you can provide upon request.
- An EU Responsible Person has been designated for the product. This requirement comes into effect in 16 July 2021 pursuant to the new Market Surveillance Regulation (EU) 2019/1020. It applies to all CE marked products except medical devices, explosives for civil uses, and certain lifts and cableway installation. If your brand is EU based, the Responsible Person is the Brand. If your Brand is based outside of the EU, the Brand should ensure there is a Responsible Person for products sold in the EU.
What is an EU Declaration of Conformity (DoC)?
A Declaration of conformity (DoC) is a document signed by a manufacturer or authorised representative confirming that the product placed in the market complies with applicable EU requirements, and is required for all CE Marked products sold in the EU with few exceptions. The contents of the Declaration of Conformity shall follow the model declarations set out in Annex III to Decision 768/2008/EC or in annexes to applicable legislation.
By the drawing up and signing of the Declaration Conformity, the manufacturer takes responsibility for product compliance with all applicable EU laws.
You should consult applicable legislation to ensure the Declaration of Conformity meets all applicable requirements.
At a minimum, the DoC must clearly include the following information:
When requested, the DoC should be provided in a non-editable format (for example, PDF), and must be signed by a responsible employee of the manufacturer (including the employee’s printed name and position).
Further guidance on the creation of the DoC and the related requirements can be found here.
What is a Declaration of Performance (DoP)?
Construction products covered by a European harmonised standard or for which a European Technical Assessment has been issued, are required to have a Declaration of Performance (DoP) issued by the manufacturer instead of a DoC. In addition to the requirements of a DoC, the DoP must provide information about product’s essential requirements (e.g., durability, thickness, reaction to fire), the performance of the product and the harmonised technical specifications. Furthermore, the product itself has to be CE marked.
What is a harmonised standard?
For some product types, the EU has created harmonized standards that manufacturers, other economic operators, or conformity assessment bodies can use to demonstrate that products comply with relevant EU legislation. For detailed information, refer to the information on this page.
Is the EU DoC/DoP the only compliance document that I need?
No. CE-marked products require additional required compliance documents (for example, test reports or certificates) to further demonstrate the compliance of the product. Depending on the product type, technical documentation should provide information on the design, manufacture, and operation of a product, and are necessary to demonstrate compliance of the product and support the DoC or DoP. You need the technical documentation before products are placed on the EU market and in order to affix the CE mark to the product. The contents of technical documentation are specified in Annex II of Decision 768/2008/EC and in applicable legislation. The technical file usually includes test reports, product certificates, technical drawings, factory certificates, quality assurance and control documentation, bill of materials, etc. The technical file should be updated periodically and must be updated if there are material product changes.
You may be required to provide these documents at short notice, so it is important to ensure that you have access to any required compliance documents for all of your CE marked products.
What is a Responsible Person?
On July 16, 2021, a new EU Regulation on product safety (called the “Market Surveillance Regulation (EU) 2019/1020”) is coming into effect. This new regulation adds the requirement for all CE-marked products (except for medical devices, cableway installations, explosives for civil uses, hot-water boilers, and lifts) to have someone present in the European Union acting as the point of contact for product compliance and to deal with certain compliance related activities (a “Responsible Person”).