Step 1: Determine Applicable Directives and Standards

What is CE Marking?

If you are new to CE marking, please watch this video first:

Introduction to the Terminology: What are Directives, Regulations, and Standards?

In the next video, I show you the difference between directives and standards, the relevance of both for CE marking, and how you can determine which directives and standards apply to your products.

Please note that the European Commission, European Council, and European Parliament have started to use legal instruments other than directives to regulate product safety and environmental protection, for example, the Regulation (e.g. Construction Products Regulation or the Medical Devices Regulation). Where in ‘Six Step CE Marking Framework’ we speak of ‘directives’ or ‘CE directives’, we also refer to the new Regulations.

Watch this video:

Directives vs Standards

You should understand the difference between standards and CE directives. Standards are voluntary. And despite what the name implies, directives are obligatory. In other words, the essential requirements of the directives are the law. Standards are merely a reference. If no standards have been applied to your product, that does not mean the product cannot be CE-approved. It is better if you can show compliance with the standards because you would be referring to a well-accepted industry practice. However, deviations from the standards are possible. As long as you can prove that the design solution you have chosen is safe and that it fits within the safety framework set by the essential requirements of the appropriate CE marking directive, you are perfectly fine.

The CE marking regulations have a very particular relationship with standards: if a product complies with the relevant requirements of all appropriate European harmonized standards, it is automatically presumed to comply with the appropriate CE regulations (this principle is often referred to as the ‘presumption of conformity’). In other words, if your product is tested and approved according to the relevant European harmonized standards, it can be affixed with the CE marking, because it is presumed to comply with the CE marking regulations. This is why standards provide an easy way to check CE compliance.

Please note: This ‘presumption of conformity’ is accepted only for European harmonized standards, and even then only in the case where all relevant European harmonized standards have been applied.

The CE marking cannot be affixed on the basis of compliance with UL or CSA standards. European standards are recognizable by the abbreviation ‘EN’ in their reference code (e.g. BS-EN 60204-1). European standards are only considered European harmonized standards if the European legislator published its reference number on a list.

Assignment: Define the Intended Purpose

For CE certification, it is very important to have an accurate product specification and an extensive description of the product’s intended purpose. On the basis of the description of the intended purpose, you and your testing and certification service providers are going to base the decision on concerning the applicable CE directives and standards. The market surveillance and inspection bodies that check compliance also will use the intended purpose to check if the correct legislation and standards have been applied, and if the CE marking is correct. Therefore, if you get this important first step wrong, all your CE efforts may be in vain. Therefore, please spend sufficient time on this step. The more information you can provide, the better it is.

Use the following template to make your own description of the product that you are getting CE marked (Select the text in the box below and copy and paste it into your word processor or text editor. Click “Save as” and the document in the .txt format. Send the document to your coach.

Product name:
Model:
Date:
Performed by:

Intended Purpose:

Please include in your description of the intended purpose the following elements:
– What is the product? (Try to explain as you would explain to a child)
– What does the product do? What is the product used for? (Try to explain as you would explain to a child)
– What is it NOT intended to be used for?
– For which persons are the products intended?
– For which persons the products are not intended?
– In what kind of environment are the products intended to be used (e.g. outdoors, indoors, domestic environment, industrial environment, potential explosive environment, hospital environment, office environment, scientific environment, etc.)
– Does the product require accessories or peripheral equipment in order to function?

Classification Rationale

Probably the most important step in the CE marking certification process is to determine which CE marking directives apply to your product. Only after you know which directive or directives apply, you can determine which requirements the product must fulfill and how the compliance must be assessed. You may want to give this step some special attention because if the wrong directives are selected and applied, all your CE marking efforts would be in vain. And your products could even be prohibited from sale in Europe.

Finding out which CE marking directive applies to your product, can be very complex and time-consuming. There are currently more than 20 CE marking directives, and more than one CE marking directive can apply to a single product.

Have you been looking for a database or list that tells you which directives and standards apply to a product? You can stop searching. Such a list or database does not exist.

The field of application of European CE marking directives is simply not determined by a list of products. Of course, that would have made it so much easier. But it would also mean that the CE directives would be rigid and not flexible enough to include brand-new technologies. And as you know, the state of the art in technology is changing constantly. So, instead of providing lists of products to which a directive applies, the European legislator took a different approach: to give a definition or a description of product features that determine if a product falls within the field of application of a directive.

This makes the process of finding the applicable directives complicated and rather frustrating if you are not a specialist. Basically, because you need to check some 20+ directives before you can draw conclusions.

To make the process of the selection of the relevant CE marking directives a little easier, our staff will help you to determine which directives/regulations and which standards apply to your product. We will contact you to provide us with the product information we need to assist you.

Applicable European Harmonised Standards

In the previous step, you have determined the CE directive or CE directives (or regulations) apply to your product(s). In this step, you are going to investigate which European harmonized standards (or in the case of construction products: European Technical Approvals (ETAs)) apply to the product(s).

The Role of European Harmonized Standards

As we have discussed, standards are often applied for conformity assessment. The CE marking regulations have a very particular relationship with standards: if your product meets the relevant specifications of all appropriate European harmonized standards, it is automatically presumed to comply with the appropriate CE regulations. In other words, if your product is tested and approved according to the European harmonized standards, it can be affixed with the CE marking, because the product is presumed to comply with the CE marking regulations. This is why standards provide an easy way to check CE compliance.

Please note: This ‘presumption of conformity’ is accepted only for European harmonized standards, and even then only in the case where all relevant specifications of all relevant European harmonized standards have been applied. The CE marking cannot be affixed on the basis of compliance with UL or CSA standards. European standards are recognizable by the abbreviation ‘EN’ in their reference code (e.g. BS-EN 60204-1). European standards are only considered European harmonized standards if the European legislator published its reference number on a list.

European harmonized standards can be recognized by the abbreviation ‘EN’ before the standard numbers (for example ‘EN 60204-1’, which may also be found as ‘DIN-EN 60204-1’ or ‘BS-EN 60204-1’ etc. depending on which national standards body the standard was obtained from.

For each CE marking regulation, a list of European harmonized standards is published. Standards are often updated in order to reflect the latest state-of-the-art technology. On average, every five years a new version of the standard is adopted and published. For this reason, the lists of European harmonized standards also are updated often. Therefore, it is important that you regularly check the list of European harmonized standards, whether or not the European harmonized standards that have been applied for your product?s CE approval are still valid, or the presumption of conformity has been repealed in favor of a new version of that standard.

The term ‘harmonized’ in European harmonized standard does not refer to harmonization between international standards. It refers to the fact that the content of the standard is presumed to be harmonized with all or parts of the essential requirements of the Directive to which the standard pertains. However, many European standards are actually harmonized with international standards. For example, most European standards for electrical products are harmonized with the standards of the International Electrotechnical Committee (IEC). Additionally, an increasing number of ISO standards also are adopted as European harmonized standards.

If your product complies with the requirements of an (inter)national standard that is harmonized with a European harmonized standard, you will already know whether it will comply with the European harmonized standard. For example, one of my clients applied the Australian standard AS 10535-2002 ‘Hoists for the transfer of disabled persons – Requirements and test methods.’ This standard is harmonized with the equivalent European harmonized standard, EN 10535:1998. As such, my client knew that his product would meet the EN standard as well, and subsequently, that the presumption of conformity would be valid and the CE marking could be affixed. The only challenge that remained was to include in the Technical File a conformity assessment report or test report referring to the EN standard instead of the Australian standard, because the CE Marking only can be affixed on the basis of a European harmonized standard.
 

The application of standards is voluntary

You should understand the difference between standards and CE regulations (which are called ‘directives’). Standards are voluntary. Despite what the name implies, directives are obligatory. In other words, the essential requirements of the directives are the law. Standards are merely a reference.

In other words, if your product fails to meet the standards, that does not mean the product cannot be CE-approved. Although it is better if you can show compliance with the standards because you would be referring to a well-accepted industry practice, deviations from the standards are possible. As long as you can prove that the design solution you have chosen is safe, and that it fits within the safety framework set by the essential requirements of the appropriate CE marking directive, you are perfectly fine.

Please Note: Some CE marking directives may require you to involve a third-party certification body in case you are deviating from a European harmonized standard. In the EMC Directive, which sets requirements for electromagnetic interference of products containing electronics and active components, standards are, though not in theory, in fact, obligatory. This is because the test parameters and limits are specified in the EMC standards. And because electromagnetic interference is invisible, there is basically no other way of proving compliance than by testing according to the EMC standards. However, in CE marking this is an exception, and for most directives, it is possible to deviate from the provisions of the standards.

For this reason, and because standards in general are consensus documents supported by the industry, the application of standards is certainly the easiest way to prove compliance with the CE requirements. I also should note that the national market surveillance authorities that are responsible for enforcement of the CE compliance, preferably use European harmonized standards to control product compliance. Therefore, if you want to know what the enforcement authorities are going to look for when they will review your product(s), look at the applicable standards.

How to find the applicable standards for a product?

Tip: Look at the websites or product documentation of competing products and see what standards they are listing. Just remember to focus on ‘EN’ standards only.

For each of the CE directives/regulations you determined to be applicable in the previous step, download the latest version of the list of European harmonized standards. You can download the lists from our Library.
1. Go to the Library;
2. Click on the directive that you identified to be applicable;
3. Click on the sub-directory “Standardization”;
4. Click to download the documents with the highest reference for the year (e.g. 2012 stands for a document published in 2012), and the highest number in the sequence (C159 is more recent than C87). These are always the latest version of the lists. You can check that you have the more recent list by opening the document and checking the date of publication in the header of the document;
5. Open a text editor on your computer. Study the list by looking at the standard titles and the descriptions, and write down the reference numbers of the standards you think may apply. You don’t just have to note the standards that are specific to your products, but also the ones that cover parts, components, materials, user applications, etc. Later you can narrow your selection down. Copy and paste the standard numbers and descriptions into the text editor.
6. When you are finished, save the document in .txt format, and send it to your CE coach.