The CE marking process is usually very overwhelming for manufacturers with little or no knowledge on the topic. As a result, they often feel lost in the regulatory maze. To help out, we’ve provided a detailed description of all the steps that the CE marking process can include.
So, depending on the relevant directives and their product safety requirements, the CE marking process may include a few or all of the following steps:
- Identifying applicable EU directives
- Selecting relevant safety standards
- Notified body assessment
- External or internal lab testing
- Compilation of technical documentation
- Creation of a Declaration of Conformity
- Product marking and labelling
Step I. Identify relevant CE marking directives
The EU directives state the essential requirements a product must meet to enter the EU single market. Each CE marking directive is a legal document and can sometimes be hard to interpret, especially if you’re a newbie in CE marking.
Most non-food products fall within the scope of at least one of the CE marking directives. And manufacturers of such products must pass the CE marking process. There are cases when a product will fall within the scope of two or more directives. Then, the manufacturer must comply with the relevant requirements of all applicable directives to receive a CE marking approval.
Additionally, there are several other non-CE marking directives manufacturers should consider when undergoing the CE marking process. These directives often concern environmental and sustainability issues: GDPS, WEEE, REACH and BATTERY Directive.
To determine what directive(s) apply to a product, start by answering the following questions:
- Who will be the user of the product?
- What are the conditions for installing/using the product?
- Is the product intended for home or industrial/agricultural use?
- Where is the product going to be sold? (Some EU countries still have certain national stipulations)
Step II. Select relevant standards
Except for identifying relevant CE marking directives, manufacturers wanting to place products on the market must also identify applicable standards. These are documents that specify the necessary requirements and technical specifications a product must comply with to meet the safety requirements of the relevant CE marking directive(s).
There is a number of standards “approved” to cover the essential requirements in each CE marking directive. These are the harmonised standards. A standard can be harmonised with one or several directives. This means that if a product meets the technical requirements in the relevant harmonised standard, it automatically meets the essential requirements in the corresponding directive. Harmonised standards can make life easier for manufacturers because then there is no need for them to interpret the legal text of the directive.
Manufacturers are not obligated to use harmonised standards to ensure their products’ compliance with the relevant CE directives. However, it’s absolutely the easiest way.
Step III. Notified Body assessment
A Notified Body is an EU conformity organisation that assesses the CE conformity of certain types of products. These bodies carry out tasks related to conformity assessment, such as a review of the technical file and test reports or inspection of production facilities. Each EU directive states whether a product needs to pass a Notified Body assessment to receive a CE marking approval. It is crucial that you, as a manufacturer or importer, know what the relevant directives demand because the Notified body assessment is not mandatory for all products.
If you need to involve a Notified Body, it is advisable to submit your application as early as possible and have a consultation with an expert in CE marking to make sure that the Notified Body assessment will smoothly. Doing so simplifies the subsequent work and saves you a lot of time.
You can find a list of all Notified Bodies in the NANDO database.
Step IV. Lab testing
Some products need to be tested at an external lab to verify that they meet the requirements of the relevant EU directives. But depending on the applicable product safety requirements, the testing can sometimes be performed in-house.
This step of the CE marking process often involves conducting a risk analysis and creating a risk management file.
Step V. Compiling technical documentation
As part of the CE marking process, manufacturers must compile technical documentation. The content of this documentation is stated in the relevant CE directive(s). At the end, the documentation should prove a product’s compliance with the CE marking legislation.
The technical documentation is also known as a technical file. It includes information about the design, production and use of a product. In other words, it contains everything necessary to show that a product bearing the CE marking symbol meets the essential product safety requirements.
In general, the documentation should contain the following files:
- A general product description;
- Information about the design (e.g. circuit diagrams, design drawings, mechanical drawings, component list, manufacturing documentation, etc.)
- Description and explanations that could help understand the abovementioned drawings;
- Installation description and user manual;
- A list of all the standards used either fully or partially, or other methods for verifying compliance with the relevant CE directive(s);
- Other documents, such as calculations, simulations, etc.
- Test reports;
- And a copy of the EU Declaration of Conformity.
Manufacturers must store the technical file in the European Union for a certain period after the last product is sold. This period is often 10 years, but it could also be 5 years. The relevant CE marking directive(s) specify the exact timeframe.
The technical documentation must always be available and immediately provided to the national market authorities upon their request. If the documentation is incomplete, the manufacturer has a 14-day period to secure the missing documents.
Step VI. Creating a Declaration of Conformity
When the technical documentation is ready, the manufacturer must formally state that the product meets all relevant product safety requirements of the applicable CE marking directives. This is done by creating and signing a Declaration of Conformity.
The Declaration of Conformity is a legal document by which the manufacturer of a product declares that the product fulfils the essential requirements in the relevant CE directives. The person responsible for undergoing and passing the CE marking process should sign the document. That is usually the CEO of the company or the product owner.
When the manufacturing facilities are overseas, the importer is responsible for ensuring the CE compliance of the product. In such a case, the importer has the right to create and sign the Declaration of Conformity.
A Declaration of Conformity normally includes the following elements:
- Name and address of the manufacturer/importer issuing the declaration.
- Identification of the product (name, type or model number, as well as all relevant additional information, such as a serial number).
- Reference in an exact, complete and clearly defined manner to the applicable CE directives.
- The harmonised standards or other methods used to verify that the product complies with the requirements of the relevant directives. These must be accurately, completely and clearly defined.
- The date of issue of the declaration.
- Name, signature and work title of the person signing the declaration.
- A statement that the manufacturer or the EU authorised representative bears the sole responsibility for the product’s compliance.
- Name, address and identification number of any Notified body that took part in the CE marking process.
Step VII. Product marking and labelling
The very end of the CE marking process is when manufacturers need to take care of the product labelling. They can affix the CE marking symbol to the product’s surface or its data plate and on the packaging. The correct marking, together with the Declaration of Conformity, testifies that the product is fully compliant with the CE marking legislation.
Manufacturers should follow the following labelling rules:
- The CE marking symbol must consist of the letters “CE”.
- If the CE marking is smaller or bigger, the legal proportions should be maintained.
- The symbol must be in a visible and legible form.
- When it is not practically possible to affix the CE marking to the product itself (due to size or design), manufacturers can place the symbol on the packaging and in any accompanying documentation instead.
- The marking must be durable so that it can resist to external factors.
- The different components (letters) of the CE marking should be approximately equal in height and not smaller than 5 mm.
- If there is the need for involving a Notified Body in the CE marking process, manufacturers must include the ID number of the Notified body below or next to the CE marking symbol.
If you’re in need of any CE marking help or have some questions, contact Clever Compliance at [email protected]. Our highly experienced team of experts will provide you with the necessary guidance and assistance throughout the CE marking process so that you can get a CE marking approval for your product as soon as possible.
But if you’re an experienced compliance manager, then you may want to take a look at our product compliance management system. It helps corporations and large enterprises streamline their compliance operations and facilitate collaboration and coordination between the compliance teams and all other internal departments. And if that’s not enough, it can also be integrated with our supplier compliance software.