CE Marking: Guide to European Conformity Certificate

What is a CE certificate? What does it mean?

The CE marking (or certificate) whose initials are based on the term “Conformité Européenne” (“European Conformity”, originally in French) is a symbol that confirms that the manufacturer or legally responsible person has complied with the essential requirements for safety, health and environmental protection required by the EU in that sector.

This is an official European Union (EU) mark and certificate for specific industry groups, and is regulated by Directive 93/68/EEC.

However, it is very important to note that it is simply an official sign that it complies with European legislation in terms of safety, not that it has been manufactured in the EU. Therefore, it is not a mark of origin.

What is CE marking for?

According to official EU sources, there are two main benefits that CE marking brings to companies and consumers within the EEA:.

• Businesses know that products bearing the CE marking can be marketed in the EEA without restriction
• Consumers enjoy the same level of health, safety and environmental protection throughout the EEA

The CE marking is part of the EU harmonisation legislation, which is mainly managed by the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Alongside this, the CE marking for Restriction of Hazardous Substances is managed by the Directorate-General for the Environment

The CE marking also supports fair competition by encouraging all companies to be held accountable to the same rules.

Is CE marking mandatory?

Basically, depending on the EU specifications and the character of your product, it is determined whether CE marking is mandatory or not.

It is generally mandatory, and must be checked for compliance with all legal requirements before the certificate is affixed. Its insertion is required before starting the marketing flow in the European Union.

However, if the products do not have a “new approach directive”, i.e. a body that regulates them and establishes their obligations, it is not mandatory to affix the marking. It is free of the CE marking and must not contain it aesthetically. But not only that, it is forbidden to insert this marking if the product does not need it or if there is no specific set of requirements laid down.

“It is independent of whether the product has an economic benefit or is free; and also independent of the sales technique, both in catalogue and e-commerce, as long as the final market is the EU,” say official sources from the Community of Madrid.

“It is mainly the responsibility of the manufacturer, but also the responsibility of the representative, importer and distributor. They all have to ensure that they put a safe product on the market for the end user,” specify.

Legislative framework of CE marking

However, a major dilemma arises when 27 countries, with 27 different legislations, intend to play by the “same rules of the game”. Because of the need for harmony, concordance and fairness, the New Approach Directives were formed.

These “provide for pre-and-post-market controls of products in order to ensure a high level of product safety,” the EU reports. These controls are assessed by Regulation 765/2008 and Decision 768/2008.

Also, these directives follow these benchmarks to ensure improved implementation:

• Notified bodies
• Conformity assessment procedures for products
• Enforcement measures and market surveillance
• Consistent and effective implementation of New Approach Directives

So, as we have seen above, products that do not fall under a New Approach Directive, as in this list, do not have to comply with any specific regulation determining this certificate. Therefore, it would be lying to the consumer to place it without need or obligation.

Clear circumstances where products can be sold or offered without the CE marking are:

1. Manufacturing of products exported to countries outside the European Union.
2. Products free of marking despite belonging to a Directive.
3. Equipment previously manufactured in the EU that has been slightly modified or repaired.

How to obtain CE marking? Phases of the process

CE marking does not require a licence to use its marking or sign of compliance, so it is the seller or manufacturer themselves who is responsible for reporting European Conformity on the product. You just need to make sure that:

• Your product is within a sector or field that requires legal guidelines
• That these guidelines or requirements are in place for your product
• Whether you can determine the product requirements yourself or whether it is necessary to go to a “notified body”
• You generate a technical file proving the European conformity of manufacture
• You compose and sign a declaration of conformity with the EU
• Finally, affix the CE marking

The latter is essential because the competent authorities in each country can demand documentation and proof of the CE certificate at any time.

Here you can see a schematic image of the marking and certification process.

Is independent assessment mandatory?

It is not mandatory in all cases, but you should check if your product requires assessment by a notified body. You can check this at the following official EU link for the applicable standards.

If you happen to be obliged to require a notified body, the identification number of the notified body must also be placed on the product, so that it is understandable and obvious that both marks are related to each other. You can find a notified body in this database.

Make it clear again that you and/or your organisation are responsible for assessing the technical and legal aspects in case the perspective of an independent body is not required. Don’t forget to have all documents in order and in a clear way for the hypothetical inspector!

Do I have to pay for the CE marking?

If a notified (or independent) body has to assess your product, you will have to pay the cost of the certification process. This is relative to a number of factors depending on the manufacturer to be tested. If, fortunately, you can do it yourself, you will not have to pay anything.

What happens if my product is non-compliant?

Let’s take an example: Our product poses a health or safety hazard to consumers, or adversely affects the environment. Simply put, you will not get the certificate and, if the marking has been affixed previously, you must immediately correct the problems that have led to the infringement.

We recommend that you follow the guidelines of the ISO 14001 Environmental Management System Standard to follow the international recommendations for green protection. Also the ISO 45001 for occupational safety.

If the non-conformity continues, you risk a financial penalty and a product ban, with the possibility of further consequences depending on which Member State is in control of your sector.

Non-conformity is caused by non-compliance with the required safety/health/environmental requirements, incorrect use of the rules laid down by New Approach Directives, or non-use of related standards by regulatory bodies.

Downloading CE marking and rules for affixing

“The CE marking must be affixed in such a way as to be visible, legible and indelible. On the marking, which consists of the initials “CE”, both letters must have the same height, which may not be less than 5 mm (unless otherwise specified in the requirements of the product in question)“, explains the Community of Madrid, with regard to strict compliance with the protocols.

“If you want to reduce or enlarge the CE marking on your product, you must respect the proportions of the two letters. As long as the initials are visible, the CE marking can take different forms (e.g. colour, be solid or hollow)“, they continue.

“If the CE marking cannot be affixed to the product itself, it can be affixed to the packaging – if the product is packaged – or to any document accompanying the product. If the product is subject to several EU directives or regulations requiring the affixing of the CE marking, the documents accompanying the product must indicate that the product conforms to all applicable EU directives and regulations”,concludes.

In the following link, you can download the CE marking files, free to use.

If you still have doubts about how to implement this certificate, here is an index of the rules for affixing the CE Marking:

• The proportions must be maintained, with a minimum vertical dimension of 5 mm.
• It must be affixed to the product or its descriptive plaque. Where this is not possible, it shall be affixed to the packaging, if any, and on the accompanying documents, if required by the Directive.
• It shall be affixed visibly, legibly and indelibly.
• It must be followed by the identification number(s) of the Notified Body(ies) involved, if any.
• It is the only marking indicating that the product complies with the applicable Directives.
• It must be affixed at the end of the production control phase.
• It shall be affixed by the manufacturer or his authorised representative within the European Union.
• Exceptionally, where permitted by the Directive, it may be affixed by the person responsible for placing the product on the market in the European Union.
• The affixing of signs which may be confused with the CE marking, both in meaning and form, is prohibited. A product may bear other marks or stamps, provided that they are not confused with the CE marking and that they do not reduce the legibility and visibility of the CE marking.
• Manufacturers who have marks liable to be confused with the CE marking are allowed to keep their mark for 10 years after the adoption of the regulation if these marks have been registered before 30/06/89 and are currently in service.

Is CE Marking still valid in the UK? UKCA Marking

To allow businesses to adapt to the recent changes brought about by Brexit, the British Government has decided to allow CE marking to be used, in most cases, until 31 December.

After that date, the UKCA marking must be used for products marketed in the UK market (England, Scotland and Wales). This marking will not be valid for the European market, nor is it valid for Northern Ireland.

“In most cases, if your product has been placed on the GB market with a CE mark before 11pm on 31 December 2022, it does not need to be remarked or recertified to UKCA requirements and can continue to circulate on the GB market until it reaches its end user. This also includes if the CE marked product was conformity assessed and certified by a conformity assessment body established in the UK before 11pm on 31 December 2020”, explains the UK government.

“There is no need to re-test and re-mark existing imported stock for goods that are manufactured, CE-marked and imported under contract into the UK by 11pm on 31 December 2022”, they add.

This will apply for most products requiring UKCA marking unless there are special rules in place for your specific product area:

• Medical devices
• Construction products
• Cableways
• Transportable pressure equipment
• Unmanned aircraft systems
• Rail products
• Marine equipment

How to use the UKCA marking

The rules for affixing are currently the same as those for CE Marking. However, in the future, the UK government plans to introduce legislation to extend the period during which the UKCA marking can be affixed to a sticker or accompanying document.

Similarly, UKCA marking “must only be placed on a product by you as the manufacturer, your authorised representative (where permitted in the relevant legislation), or if you are marketing the products under your name or trademark”. And therefore, “you take full responsibility for conformity with the requirements of the relevant UK legislation”, report.

You can download the files for the UKCA images here (fill) and here (outline).

And don’t forget:

• If you reduce or enlarge the size of your marking, the letters forming the UKCA marking must be in proportion to the version above
• The UKCA marking is at least 5mm in height unless a different minimum dimension is specified in the relevant legislation
• The UKCA marking is easily visible, legible and indelible

How to check and control the conformity of my CE products: Digital techniques

Once you know the requirements to be met by your product and all the steps to follow, it is essential and necessary that you control the production processes so that you do not make mistakes. By doing so, you can ensure the consistency of safety, health and environmental protection required for CE marking.

The strongest companies on the market use control and inspection software/apps such as Lumiform, with which for little money you can have German technology for maximum efficiency in organisation and control.

The software allows you to create audits and control/check forms on any area through the information you provide. Being intuitive and easy to use, you can use it with any employee and get real time information about everything that is going on in your production and business.

You can check whether CE marking obligations are being met through the real-time results you get with the program. It highlights areas for improvement and monitors the reports. In case of a failure, risk, or shortcoming, you will be informed immediately. You can also be in constant communication with your employees in case a bad situation occurs.

Basically, you ensure CE quality in your production with innovative and effective management, improving control of your organisation without losing anything. By taking advantage of technological advances to better organise paperwork and secure all documents that can be claimed by regulatory bodies for marking in the cloud, you will save time and money, so you can focus on your business.

Times are constantly changing as are EU requirements, the market, and production methodologies. If you want to learn about philosophies to improve your productivity and your business, you can read these free guides.

If you need information of official relevance regarding CE marking and certification, we recommend you visit the following pages:

• UK Government (UK)
• European Commission