Demystifying CE Marking: A Simplified Guide to Mastering European Regulations

Introduction

If you have started reading this article, it is likely because you are navigating the complexities of CE marking and European regulations. Perhaps you have already explored a few resources but found the explanations vague and the jargon difficult to decipher.

Rest assured, our goal is simple: to share key information with you while simplifying it as much as possible. We have prioritized simplicity in this article to effectively inform you about applicable elements and potential risks.

The idea for this article surfaced when thinking back to the questions we asked ourselves 7 years ago regarding CE marking, the ones for which we would have liked more direct and accessible explanations.

What is CE Marking and is it Mandatory?

Yes, CE marking is mandatory to market your products.

In the European Union, CE marking is required for placing products on the market and standardization. It is the sign that the manufacturer of the product you hold in your hands has committed to meeting the safety requirements imposed by law and that you are not in danger when using it. To prove its safety, it will have passed a certain number of tests, verifying that the results are within the thresholds fixed by European regulation.

CE marking gives a product access to the European single market and allows its free movement within the European Economic Area, thus guaranteeing its compliance with safety requirements. This strengthens the competitiveness of companies on the European market while protecting consumers.

The CE mark affixed to products is not a certification brand but a guarantee that the product has followed a product design process in compliance with directives. To certify your product, it is not enough to just stick the logo on it, but rather to carry out a set of study and validation steps during the product design. If you affix this marking, it means you have committed to following this process. You are legally committing to respect European directives and standards.

In common parlance, obtaining "CE marking" means having successfully completed all the key stages of your product's certification, and being able to affix the "CE" knowingly.

Example of a CE marking label for our client  UNAIDE.

Who Performs CE Marking?

As part of obtaining CE marking, BLUEGRioT manages the conformity assessment procedure adapted to each product internally for its clients. There are essentially two main ways to obtain CE marking: self-certification or certification by a notified body.

What Does Self-Certification Mean?

To simplify the subject greatly, it means that you evaluate the conformity of your product yourself. To affix the CE marking, you will therefore need to:

• Determine the standards applicable to your product.
• Compile your technical file tracing the key design stages.
• Identify the list of standard normative tests and perform them.
• Ensure the results are within the thresholds determined by Europe.
• Draw up your EC Declaration of Conformity.
• Keep these documents safe in case of inspection/problems.
• Affix the "CE marking" to the product.

Is Self-Certification Feasible Completely Autonomously (Without External Resources)?

It is feasible, yes, but in reality, it is better to get support… you will understand why.

Indeed, the subject is quite complex and requires a certain knowledge of directives, and the tests to be carried out require expensive and complex equipment. Take, for example, the anechoic chamber testing of the terminal we designed for our client REYOUZZ.

BLUEGRioT is not equipped with this type of infrastructure and material. We have forged strong ties with testing laboratories like SOCOTEC over the years. This allows us privileged access to experts and testing facilities adapted to our needs.

SOCOTEC is a group specialized in Testing, Inspection, and Certification (TIC), and holds 250 external recognitions. This collaboration demonstrates our ability to offer a complete and certified service, highlighting our commitment to maintaining high reliability and expertise.

It is essential to maintain and apply standards throughout the product life cycle. For this, proactive management is recommended, in collaboration with a design bureau such as BLUEGRioT. This ensures continuous and effective product compliance on the market. Working with a design bureau also ensures that any non-conformity is identified and addressed before the product is marketed. The complete documentation, including the technical file prepared by the bureau, serves as proof of this compliance, which is essential in the event of inspection or questioning by authorities. Finally, the Signature of the EC Declaration of Conformity, which you must perform, attests that the product meets the regulatory requirements of the European Union.

If I Can Self-Certify, What is the Point of Going Through a Certified Body?

Not all products are subject to the same rules; you must start by studying which category your product falls into.

When you envision product development, you play an essential role, particularly by being responsible for:

• Identification of applicable directives: Which European directives are relevant to my product, ensuring compliance with specific EU regulations.
• Verification of specific requirements: Analysis of the detailed requirements of these directives, including those related to safety and the environment.

These actions determine the list of tests to be performed. They constitute the normative framework of your product. It is at the end of this analysis that you will know if you can self-certify your product or if it is necessary for you to call upon a certified body, as is the case for Class 2 medical devices and higher, for example.

If it reassures you, it is infrequent that our clients accomplish these tasks themselves; they regularly entrust them to us!

We previously discussed standards and directives, which may still seem abstract to some.

What are the Differences Between Standards and Directives?

Directives are legislative texts of the European Union which set the objectives to be achieved by Member States.

Standards are technical specifications established to demonstrate compliance with directives. At BLUEGRioT, for most of our creations, we focus particularly on three major directives:

• Connected Object Directives: RED, which governs the placing on the market of radio equipment.
• EMC Directives: For electromagnetic compatibility.
• LVD Directives (Low Voltage): For product safety.

Collaboration allows for a better understanding of the directives and standards in force and helps to navigate through conformity assessment procedures with greater ease.

For each of these directives, there are specific tests we cannot list here, but we can tell you about one or two of them that left a mark on us the first time:

Some Examples of Impressive Tests!

Tests do not only concern the electronic board and its behavior. We remember impact tests!

Imagine having to design an object that must be able to withstand the fall of a pétanque ball from a height of 1 meter. This is also where one realizes the importance of knowing these tests during product design. These are, for example, the tests that had to be done on theSleepee By TIM device.

Faut-il intégrer les contraintes du marquage CE dès le début du projet ?

Sans aucun doute si vous avez des ambitions de commercialisation du produit  ! 

BLUEGRioT a intégré l’évaluations de la conformité à son processus de conception dès le début des études. Nous nous assurons, par exemple, du sérieux et de la capacité de nos fournisseurs à nous fournir des déclarations de conformité valides, documents indispensables pour constituer le dossier technique complet.

En reconnaissant les défis que nous avons nous-mêmes surmontés, une série de stratégies et de services ont été mis en place pour simplifier le processus pour nos clients, transformant nos premières difficultés en une valeur ajoutée significative pour ceux que nous accompagnons aujourd’hui.

In Which Cases is CE Marking Not Mandatory?

Some products are not subject to CE marking. To date, there are more than twenty regulatory texts grouping the different product categories for which marking is mandatory. This list is available at this address.

Any product belonging to one of these categories must be marked if you wish to market it.

However, it may be that the product you are developing is not intended to be marketed and therefore marked CE. At BLUEGRioT, we frequently encounter the following two situations:

1. Non-marketed internal use: If a product is manufactured and used exclusively within your company without being placed on the market, it is generally not necessary to affix the CE marking. [Block Field] By way of example, at BLUEGRioT, this is often the case for the test benches we design. Indeed, the test bench used to verify the functionality of your product does not require CE marking if it is for the sole use of the company's employees. We still provide complete documentation on the design and manufacture of our test benches and advise keeping it up to date in case of inspection, as you remain responsible for the safety of this bench.

2. Prototypes: As long as they are not sold and are used under controlled test conditions, they may not require CE marking. It is important to note that the prototype must clearly be identified as such and must not be used as a final product on the market. During our design phases, we systematically produce prototypes that are tested by users to validate their operation in real conditions. We then collect their feedback to adjust the product before launching the CE marking process, which avoids costs related to unnecessary tests before this validation. In some cases, pre-qualification tests are still carried out, particularly regarding the electrical safety of the product.

Prototypes made for the runes of Enhanted Tools.

The Advantages of Collaboration with BLUEGRioT

We offer detailed support to companies to navigate European standards and secure CE marking. This support includes technical evaluations and the preparation of the documentation necessary to meet regulatory standards.

The legal responsibility for product compliance lies with the person marketing the product—our clients in general. They are therefore the signatory of the Declaration of Conformity. This signature confirms that the products comply with European Union regulations and respect the CE directives and standards imposed on member states. This responsibility is essential, especially in the event of litigation, as it guarantees compliance with regulations.

Working with a design bureau allows for the identification and rectification of any non-conformity before the product reaches the market. The technical file prepared by the design bureau serves as proof of this compliance, providing important legal protection during inspections or questioning.

To strengthen our support for companies, BLUEGRioT now offers a complete support package for CE marking. We carry out in-depth audits of your products and intervene directly within your company to raise your team's awareness of CE standard requirements. This awareness training, structured into two main offers, aims to ensure accurate assessment and guide your technological decisions to guarantee the compliance of your products.

For more details on our offers and to benefit from our expertise, visit our offer page and contact us now.

The Importance of Regulatory Monitoring

Regulatory monitoring ensures product compliance with constantly evolving European standards. The proactive monitoring carried out by BLUEGRioT allows us to anticipate changes in legislation, as illustrated by the adaptation to the new USB-C cable specifications. Three years before the European Union requirements came into force, BLUEGRioT had already begun aligning its clients' products with these new standards, ensuring a smooth transition and continued compliance.

With its ISO 9001 certification, BLUEGRioT guarantees through its processes a constant and effective adaptation to regulatory changes. This strategy ensures not only product compliance but also increases their competitiveness by avoiding costly delays linked to reactive adjustments.

Conclusion

In conclusion, BLUEGRioT has gone from its early days as a novice in CE marking to an established specialist status in this field. This illustrates not only our commitment to excellence and regulatory compliance but also our ability to transform challenges into opportunities for our clients.