How to create compliant documentation for your embedded system and avoid legal pitfalls

Are you designing or developing embedded systems and are they being placed on the European market? Then there is a good change that you or your company has to deal with CE (“Conformité Européene”) marking and needs to provide compliant documentation with your system.

In this post I am going to show you how you can create compliant documentation that meets the requirements of CE marking. I have also included some templates that will support you during the process.

The CE marking process

The CE marking applies to products placed in the market or put into service in the European Economic Area (EEA) and Iceland, Norway and Liechtenstein. Besides that, CE marking only applies to certain product groups or product aspects.

In order to know if a product falls within the scope of CE marking, you need to answer the following two questions:

  1. Are your products placed on the market or used in one of the countries that are part of the CE marking system?

  2. Does the product fall within the scope of the CE marking directives?

The following countries take part in the CE marking system:

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia

Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia

Lithuania
Luxembourg
Malta
The Netherlands
Poland
Portugal
Romania
Slovakia

Slovenia
Spain
Sweden
United Kingdom
Iceland
Norway
Liechtenstein

The following products fall within the CE marking scope:

Toys
Machinery
Electrical /electronic equipment
Personal protective equipment
Radio equipment
Medical devices
Active implantable medical devices
In vitro diagnostics
Simple pressure vessels
Gas appliances

Lifts
Recreational craft
Equipment and protective systems for use in explosive atmospheres
Non-automatic weighing instruments
Cableways
Construction products
Explosives for civil use
New hot water boilers
Measuring Equipment
Pressure equipment

Common CE directives that might apply to embedded systems are the EMC directive, RoHS directive and Radio Equipment Directive. When integrated, other relevant directives might apply, such as the Low Voltage Directive or the Machinery Directive.

As soon as one or more directives apply to your product, you need to follow the CE marking process to ensure that your embedded or integrated system complies with all requirements. The CE marking process contains of six steps that you need to follow to enable you to CE mark your product.


Figure 1 – The CE marking process (Source: INSTRKTIV)

Step 1: Identify the applicable directives

First of all you need to identify whether your embedded system falls within the scope of CE marking and if so, which directives apply. There are more than 25 directives and one system can fall within the scope of more than one directive.

Based on the mentioned product groups that fall within the scope of CE marking, you can define the relevant directives. The directives can be found through the website of the European Union. In order to determine of a directive applies, you need to consult the directive and verify if the scope and given definitions of the directive apply to your product.

Step 2: Identify the applicable requirements of the directives

Each CE directive contains requirements that your embedded system needs to meet, the so called Essential Requirements. These requirements mostly are very general and not specific. A way to demonstrate that your system meets the essential requirements, is by meeting the requirements of harmonized European standards.

Although voluntary, by using standards, you create a presumption of conformity to the essential requirements of the applicable directives. You can find existing harmonized standards via the website of the European Union and selecting the several product groups.

Step 3: Identify an appropriate route to conformity

As soon as you know which directives apply to your embedded or integrated system, and additionally have identified the requirements in the standards, you need to demonstrate conformity with each directive and its requirements. However, each directive has different methods of how to demonstrate conformity, which usually depends on the classification of the product and its intended use.

Although CE marking is a self-declaration process, you may need to involve a third party, a so called Notified Body, when your product needs to comply with for example the EMC or Radio Equipment Directive. More information can be found in the relevant directives.

Step 4: Assessment of the product’s conformity

Now you know what requirements your product must meet and what the right route towards conformity is, you need to gather your evidence that the product meets the essential requirements of the directive(s).

This usually involves some assessment and/or testing. An assessment can be carried out by yourself, by creating a checklist with all requirements and adding the proof for compliance. Testing can sometimes be done by yourself or by a testing institute. If mandatory, certain type examinations need to be carried out by a Notified Body.

Step 5: Compile the technical documentation

Each directive requires to put together the technical documentation. The technical documentation is your evidence that the system meets all requirements. Depending on which directives apply to your product, the technical documentation can include the following:

  • Test reports and/or assessments from stage 4

  • Description of the intended use

  • Drawings, circuit diagrams and photos

  • User instructions

  • Bill of materials.

  • Declaration of Conformity

Consult the applicable directives to find out what your technical file should contain.

Directives also have requirements on the content of the user instructions and safety instructions. In order to sell your product in a specific market, you should make sure that your user manual complies with these requirements.

Step 6: Draw up a Declaration of Conformity and affix the CE mark

When you are sure that your embedded system conforms to the applicable CE marking directives and that your technical files is complete, you need to declare this. This is done by drawing up and signing the Declaration of Conformity (DoC). By doing so, you not only declare that your product meets all relevant legislation, but you also take full responsibility for your embedded system.

Again, also for the content of the Declaration of Conformity each directive might have its own requirements. Once you have declared compliance you can place the CE mark on your product and start selling your product.

Conclusion

That’s all there is to it. That’s how you can ensure your product meets the CE marking requirements.

The best part of all this is that you can do most of it yourself by following this step-by-step CE marking process on how to create compliant documentation.

Useful resources:

Case Study: How to create a compliant user manual

How to Draw Up the Declaration of Conformity


Ferry Vermeulen is director at Berlin based INSTRKTIV GmbH. INSTRKTIV helps brands to create compliant and user-friendly user instructions and supports in the CE marking process. Ferry is a regular speaker at conferences and publishes regularly CE marking related articles. Download his CE marking process overview.

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