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

April 10, 2018

INSTRKTIV-April 10, 2018

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.

Continue reading on page two >>

 

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