CE marking : Certified European Conformity

What is the CE marking (European Conformity) ?

The CE marking is identified by two separate letters, C and E, indicating that a product complies with European Union (EU) standards concerning safety, health and environmental protection. It is important to emphasize that the CE marking does not represent a guarantee of quality, nor does it specify the geographical origin of the product. Rather, it is a manufacturer’s commitment that its product complies with regulations.

This marking is essential for products subject to one or more European directives or regulations that require it. More than 20 EU legislative frameworks call for CE marking, encompassing various sectors such as gas appliances, medical devices, personal protective equipment, explosives for civil use, and toys, to name a few. The complete list of legislation requiring this marking can be found on the EUR-Lex website.

The CE marking facilitates the marketing and free movement of products within the European Economic Area, which includes the 27 EU countries but also Iceland, Liechtenstein and Norway. This marking is also recognized in third countries such as Switzerland, Turkey, and Northern Ireland. However, it should be noted that for the island of Great Britain, the UKCA marking will replace the CE marking requirements as of January 1, 2025.

When should you consider CE marking on your products ?

CE marking is an obligation, not an option, for all products covered by at least one European directive or regulation that requires it. Before planning the marketing of your product in Europe, make sure that it must be CE marked. Ignoring this obligation exposes your company to criminal and administrative sanctions, not to mention the risks of civil lawsuits from consumers or competitors. To determine whether your product should bear the CE marking, there is no exhaustive list.

However, you can consult the European directives or the national legislation that implements them. These documents define the types of products concerned and, where appropriate, those which are not, because they fall under specific directives or regulations. The list of EU standards requiring CE marking is available on the EUR-Lex website. If you are unsure of the CE marking requirement for your product, contact a notified body.

It is an independent body appointed by the national authorities to assess whether a product meets European standards. You can also contact the Directorate General of Companies (DGE) or a commercial representative in your country for specific advice and guidance towards useful resources for your approach.

What are the advantages of implementing CE marking on your products ?

CE marking is more than just a certification of conformity, it is a real asset for your company. When you display this marking on your products, you open the door to a multitude of benefits, which we will explore together below.

Easier access to the European market

Thanks to the CE marking, it becomes easier to market your products within the European Economic Area, which includes the 27 Member States of the European Union, as well as Iceland, Liechtenstein and Norway. This saves you the need to obtain different authorisations or certifications for each country, saving you time and money. In addition, the CE marking promotes the export of your products to other markets, such as Switzerland, Turkey or Northern Ireland.

A guarantee of safety and quality for consumers

Affixing the CE marking to your products means that they comply with essential EU standards in terms of safety, health and environmental protection. This reassures your customers, offering them the opportunity to buy with confidence. You also minimize the risks associated with product recalls or complaints, protecting your reputation and revenue.

A tool for differentiation and competitiveness

The CE marking differentiates your products on the market, demonstrating your commitment to meeting some of the highest standards worldwide. This not only allows you to stand out from your competitors, but also to consolidate your brand image. Finally, it gives you the opportunity to capture the attention of more than 500 million potential consumers in the European single market.

Why is CE marking considered a strategic tool for organizations ?

CE marking transcends simple product compliance to become a strategic catalyst for organizations. It represents a continuous improvement approach, crucial to increase performance and competitiveness. Let’s look at the key benefits of CE marking for organizations :

• Improved risk management : By adhering to European standards, organizations minimize risks related to non-compliance, avoid litigation, sanctions, and protect their brand image. This also allows them to anticipate regulatory changes and market demands.
• Process optimization : Adopting a conformity assessment procedure helps organizations simplify their design, production, quality control and distribution processes. This translates into improved efficiency, quality and productivity.
• Valuation of intangible resources : CE marking allows organizations to showcase their intangible assets such as know-how, innovation, intellectual property and brand. It also helps protect these assets and build trust in their brand.
• Stimulate innovation : Complying with European standards encourages organisations to increase their innovation capacity. They can adopt best practices, take advantage of technological advances and develop new products or services.

CE marking is essential for organizations seeking to distinguish themselves, develop and adjust to a constantly evolving competitive and regulatory landscape.

What are the key steps to obtain the CE marking ?

For your product to carry the CE marking, it is essential to follow a series of steps, dictated by the legislation specific to your product. Here are the four essential steps :

1. Identify the relevant guideline(s) for your product

The first step is to determine whether one or more European directives or regulations, requiring CE marking, apply to your product. For this, consult the exhaustive list on the EUR-Lex website. Also make sure to check the areas of application and exceptions of each piece of legislation to confirm the eligibility of your product.

2. Determine the essential requirements for your product

It is crucial to identify the basic safety, health and environmental protection standards specific to your product. These standards are specified in the annexes of the directives or regulations in question. Refer also to the harmonised standards, drawn up by the European standardisation bodies and published in the Official Journal of the EU. These standards, available on the European Standards Committee website, allow you to benefit from a presumption of conformity.

3. Assess the conformity of your product

The conformity of your product must be assessed in accordance with the requirements, following the procedures defined by the applicable legislation. You can choose from several assessment modules, ranging from self-assessment to collaboration with a notified body. These bodies, listed in the NANDO database, are authorised by national authorities to assess the conformity of products.

If their intervention is required, the identification number of the notified body must be clearly displayed next to the CE marking on the product.

4. Affix CE marking and write technical documentation

After conformity assessment, you are allowed to affix the CE marking to the product or its packaging, following the standards of size, visibility and durability. It is also imperative to prepare the technical documentation attesting to the conformity of your product. This documentation includes the EU declaration of conformity, an official document attesting compliance with the applicable standards, signed by the manufacturer or his representative.

The retention of this documentation is required for a period defined by the legislation, often 10 years after marketing.

Who can issue the CE marking ?

Contrary to what one might think, the CE marking or CE certification is not assigned by a specific European entity. It is really up to the manufacturer, or an authorised representative within the European Union, to affix the CE marking to the product. In doing so, the manufacturer certifies compliance with the required standards.

It is its responsibility to conduct or have conducted the necessary tests and analyses to verify that the product meets the essential criteria stipulated in the regulations and directives in force.

However, for certain items deemed to be high risk, such as medical devices, personal protective equipment or appliances running on gas, the intervention of a notified body is required. These bodies, designated by the national authorities, are responsible for examining the conformity of products with European standards.

They carry out tests, inspections, audits or certifications, according to the legislation. Where a product is found to be compliant, the notified body shall provide a certificate of conformity. This document authorizes the manufacturer to affix the CE marking to his product, next to the identification number of that body.

The NANDO database is at your disposal to find a Notified Body suitable for your product. It brings together all the notified bodies of the European Union. The search is facilitated by several filters: country, legislation or type of product. It is also possible to consult the list of notified bodies by country directly on the European Commission website.