What you should know about the CE mark
Bringing a product into the European Union?
You'll need to secure a CE mark to go on it.
For quality and compliance managers, the CE mark is the badge of European market success, and showcases your company's ability to market its product to almost half a billion EU citizens.
Needless to say, securing a CE mark isn't necessarily easy - so we wrote this guide to help you on your journey.
What is the CE mark?
The CE mark, short for the French conformité européenne, is a certification symbol recognized across the European Economic Area (EEA) that signifies a product’s compliance with EU safety, health and environmental protection requirements.
The CE mark is essential for goods intended for the EU market, showing that they've met appropriate testing and safety standards. This mark is not just a legal requirement; it enhances consumer trust and opens the doors of the lucrative EEA market to your company.
It does not, however, act as a certification mark or a quality indicator like, say, an ISO 9001 badge.
History and evolution of the CE mark
The CE mark became effective in Europe in 1993, as part of the European Union's New Approach Directives to harmonize product safety standards across its member states.
The aim was to create a single European market with unified safety standards, fostering greater competition and cross-border trade.
Initially, the focus of the CE mark was on removing trade barriers, but over time, the CE mark evolved to include stricter guidelines and standards to ensure higher levels of standardized safety and environmental compliance.
The CE mark has also become more comprehensive, covering various product categories, from electronics and machinery to medical devices and toys.
Importance of the CE mark in global trade
The CE mark is a critical tool in global trade, acting as a gateway to the European market, one of the largest consumer markets in the world.
Many non-EU countries also accept the CE mark as an indicator of basic product integrity, allowing products marked with it onto their own markets.
For manufacturers, obtaining the CE mark demonstrates adherence to high safety and quality standards, which enhances brand reputation and product acceptance worldwide.
The CE mark is particularly valuable for companies aiming to establish a strong international presence, both within and beyond the EEA bloc.
CE marking vs. UKCA
With the 2020 completion of Brexit, the United Kingdom developed its own certification, known as the UKCA (UK Conformity Assessed) mark.
While the CE mark remains valid for goods sold within the EU, products marketed in the UK must bear the UKCA mark.
Although similar in function and to all intents and purposes identical as of 2024, the UKCA mark may encompass different or additional requirements as the UK develops its own independent regulations.
Manufacturers aiming to sell in both markets must ensure compliance with both CE marking requirements and UKCA standards, making it essential for businesses to stay informed on these regulatory changes.
Regulatory framework
To secure a CE mark for your product, an important first step is understanding the regulatory framework around the marking process - and which parts of it pertain to your business context.
European Union regulations
The CE mark’s foundation lies in EU regulations that mandate health, safety and environmental protection standards for a wide array of products.
Various industry- and product-specific directives such as the Medical Device Regulation (MDR) and the Low Voltage Directive (LVD) lay out requirements that products must meet to qualify for the CE mark. Each directive targets specific product categories and dictates compliance standards, performance requirements and documentation obligations.
The role of notified bodies
For some products, manufacturers need to engage with an EU notified body: an independent organization authorized by the EU to assess products for compliance with CE marking directives.
Notified bodies play a critical role in the conformity assessment process, especially for high-risk products like medical devices or heavy machinery.
They perform testing, audits and inspections, ensuring that products meet the requirements before granting certification.
The notified body’s involvement depends on the specific product and the applicable directive, adding a level of expertise and impartiality to the certification process.
Harmonized standards
Harmonized standards are essential to the CE marking process. These standards are developed by European standards organizations (such as CEN, CENELEC, and ETSI) and ensure consistency in safety, health and environmental protection across the EU.
While using harmonized standards is voluntary, compliance with them provides a presumption of conformity with the relevant EU directives, making it easier to achieve the CE mark.
These standards cover diverse aspects like material safety, performance requirements and product labeling, providing manufacturers with clear guidelines to follow.
Scope and application
Products requiring the CE mark
The CE mark applies to a wide variety of products, including machinery, electrical and electronic devices, medical devices, personal protective equipment, construction materials, toys, and more.
Each category has specific directives, like the Machinery Directive or the Toy Safety Directive, outlining the requirements products must meet. Any product that falls under these categories and is intended for sale in the EU or EEA must have the CE mark.
Geographic scope of the CE mark
The CE mark is mandatory in the European Economic Area, which includes EU member states as well as countries like Norway, Iceland and Liechtenstein.
Products bearing the CE mark can move freely within this region, offering businesses reduced regulatory complexity across these national borders.
The post-Brexit UK, as well as Turkey, also uses the CE mark - albeit temporarily while it transitions to its own UKCA mark.
Exceptions and exemptions
Not all products require the CE mark.
Products like chemicals, pharmaceuticals and food items are regulated by other, more stringent EU legislation and therefore have different compliance requirements such as GMP.
Additionally, some products may fall outside the scope of EU directives altogether, such as those used exclusively in industrial settings.
Understanding whether your product requires the CE mark is crucial, as selling a product without appropriate marking can result in significant penalties and future market restrictions.
CE marking process
Steps to obtain the CE mark
To obtain the CE mark, manufacturers must follow a structured process, ensuring their product meets the requirements of applicable EU directives and regulations.
The specific pathway to obtaining your CE mark naturally depends on the type and risk class of your product.
Class I, low-risk medical devices, for instance, follow a different pathway to high-risk Class III devices.
We built a detailed, step-by-step medical device and IVD CE marking pathway guide you can download below:
And to give you a more general flavor, the broad, industry-agnostic journey for CE marking looks like this:
Identifying applicable directives
The first step in the CE marking process is identifying which EU directives apply to your product. This may involve a single directive or multiple directives, depending on the product’s intended function, components and use cases.
For instance, an electronic device might need to comply with the Low Voltage Directive and the Electromagnetic Compatibility Directive.
Medical devices would need to consider EU MDR 2017/745, or
EU IVDR 2017/746.
Conducting a risk assessment
A comprehensive risk assessment follows, identifying potential hazards associated with your product and evaluating their impact on safety and performance. The assessment ensures that any design, functionality or operational risks are mitigated according to EU standards.
Ensuring compliance with requirements
The best way to show that you have met the essential CE mark requirements is to comply with the appropriate harmonized/designated standards, and their technical and safety requirements.
This could involve design modifications, material selection and safety feature integration to align with specific standards.
In the EU, harmonized standards are the standards that have been published in the Official Journal of the European Communities.
You can check them out on the European Commission website.
Compilation of technical documentation
Technical documentation is essential to the CE marking process, serving as evidence of your product’s compliance with EU standards. The technical file typically includes the product’s design details, risk assessment results, and testing reports. This documentation must be kept for at least ten years, enabling regulatory bodies to verify compliance if necessary.
Declaration of Conformity
Finally, issue a Declaration of Conformity (DoC), a formal statement that your product complies with all relevant EU directives.
This declaration should be signed by an authorized representative, certifying your product’s eligibility for the CE mark.
Involvement of third-party conformity assessment
For certain high-risk products, an independent third-party assessment from a notified body is necessary. The level of involvement varies depending on your product’s risk category, as determined by the applicable directive.
For instance, medical devices or pressure equipment typically require testing and certification by a notified body, ensuring an additional layer of verification for safety and quality.
WATCH WEBINAR RECORDING: Unlocking the British and European markets with UKCA and CE marking
Legal requirements and liabilities
Penalties for non-compliance
Non-compliance with CE marking requirements can lead to severe penalties, including product recalls, fines, and even legal action. EU authorities may prevent non-compliant products from entering the market, and manufacturers could face substantial fines and reputational damage. For products with serious safety risks, penalties may include criminal charges against the responsible parties.
Ethical responsibilities of manufacturers
Beyond regulatory obligations, manufacturers have an ethical duty to ensure the safety and integrity of their products.
By adhering to CE marking standards, manufacturers contribute to consumer safety and environmental protection, reducing the risk of accidents, product malfunctions, and potential harm. Meeting these ethical responsibilities helps maintain consumer trust and aligns with global standards for safe and sustainable production.
Benefits of the CE mark
Market access
One of the most significant benefits of the CE mark is gaining access to the vast, $16.6tn GDP European market. With the CE mark, your product can move freely across EU and EEA countries without facing additional regulatory obstacles, giving you a significant advantage in reaching consumers across Europe.
For many companies, the CE mark is essential to their international growth strategy.
Improved product safety
The CE mark ensures your products meet high safety standards, protecting consumers from hazardous materials, malfunctions, or injuries. By obtaining the CE mark, manufacturers demonstrate their commitment to safety, quality, and regulatory compliance, which can enhance their brand reputation and customer loyalty.
International recognition
Although specific to the EU, the CE mark has, as we've seen, become recognized in many regions worldwide, making it easier for manufacturers to expand their reach beyond Europe.
The mark acts as a recognizable symbol of quality and safety, often accepted and acknowledged by consumers and businesses outside the EU, which can simplify market entry and build brand credibility on a global scale.
Using an eQMS to get and keep your CE mark
As you've learned by now, securing a CE mark can be a long and complex process.
Many companies are turning to CE and UKCA marking software to accelerate and simplify the journey.
Implementing a quality management system (QMS) is invaluable for companies seeking to obtain and maintain their CE marks - and digitizing it with an electronic quality management system (eQMS) helps standardize processes, spot compliance gaps, and maintain quality across every stage of your product lifecycle.
A robust, easy-to-use eQMS like Qualio empowers you to collaborate on a cloud-based digital stack of technical documentation, build flexible action workflows to get things done, train your colleagues, and quickly spot and fix compliance issues.
The end result?
Faster, easier CE marking - and strong, long-term EU compliance.
