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Declaration of conformity template method

Declaration of Conformity Template Method: How to Draw Up a Compliant CE-Declaration of Conformity for all 25 CE-Product Groups Within Minutes (updated 25-12-16)

Ferry Vermeulen Law and Legislation

Are you writing user manuals, are you setting up you own web shop, are you importing products into the EU, are you exporting to the EU or are you working at the R&D department of a company? There is a good chance that you will have to deal with a declaration of conformity.

Today, I am going to show you how to draw up a fully compliant declaration of conformity.

And... after reading this post, you will be able to do this all by yourself, without studying for days about all those EU directives.

Just follow the steps of my Declaration-of-Conformity-Template-Method and use the templates and examples I have provided in this post.

Drawing up a Declaration of Conformity

Whether you are setting up your own web shop, importing or manufacturing products, exporting to the EU, are working on the R & D department of any company or are an entrepreneur, technical writer, QA manager or translator, the chances are good that you will have to deal with a declaration of conformity (DoC).

These legal documents that are the last step in the process of CE-marking, need to be integrated into the user manual, or need to be included with the product you (or your company) sell, or in the technical file.

Someone has to draw up the declaration of conformity. And if there is no official safety expert, the company often relies on the technical author or product engineer. And if there is no technical writer or product engineer you might be responsible for the declaration of conformity yourself!

Do you struggle with drawing up a compliant declaration of conformity?

Well,.. not any more!

Read on to learn how to create a compliant declaration of conformity for your specific product.

Being involved in both product development and technical communication, I have always been interested in CE-marking. That's why I got more and more involved in the CE marking process, risk analysis, technical files and compiling declaration of conformities.

Declaration of Conformity

Before I used the method that I describe in this post, I spent ages on the internet, finding the right information on what to include in the declaration of conformity and what not. And at the end I still wasn't sure!

That's why I structured this way of working and 'developed' the Declaration-of-Conformity-Template Method.

By using the Declaration-of-Conformity-Template-Method:

  • I do not need to crawl through the maze of those ever changing EU websites (however I think I am one of the few who actually finds this interesting).
  • It is very clear what information should be included in the EU-Declaration of Conformity for a certain product.
  • I always have a good example of a declaration of conformity for my product group.

And the best part? You can do exactly the same! The only thing you need to do is to follow the steps as described below. It is a method that includes good examples and templates for each product group that requires a declaration of conformity. So if you want to draw up compliant declaration of conformities, keep on reading!

Let’s break it down into actionable steps.

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Just 4 steps bring you to a compliant declaration of conformity

There are just 4 steps that make up The Declaration-of-Conformity-Template-method:

  1. Go to the EU site. Select your product group(s).
  2. Find all the information about the declaration of conformity in the directive you need
  3. Download the correct template(s) and draw up your  declaration of conformity
  4. Check if you have met all the requirements

Step #1 Go to the EU site and find your directives

There are 25 product groups that require CE-marking and thus a declaration of conformity. By the way, for construction products the document is called a Declaration of Performance and for partly completed machinery a Declaration of Incorporation. For the sake of simplicity, in this article I will call all of them declaration of conformity.

If you have a product that fits into one of those product groups, then you have to draw up a declaration of conformity.  

Many products need to comply with more than one directive. If this is the case for your product, all steps described below need to be performed for each applicable directive. 

The requirements for the contents of the declaration of conformity can mostly also be found in the applicable directive. Most directives have their own specifications regarding the declaration of conformity and very few directives have exactly the same requirements.

Sometimes you will not find any requirements regarding the declaration of conformity in a directive (e.g. the Directive 90/385/EEC on Active Implantable Medical Devices does not give any requirements). For those directives the harmonised standard EN-ISO/IEC 17050-1:2014 Supplier's declaration of conformity -- Part 1: General requirements can be used. Because, above all, compliance with harmonised standards provides a presumption of conformity with the directive.

But if a directive has its own specific requirements, like the Machinery Directive or the Radio Equipment Directive, the EN-ISO/IEC 17050-1:2014 can be used as a basis, but it should be enhanced or modified according to the additional requirements as set out in the directive.

Another thing to be aware of is that directives change now and again. And if they change, there is a big chance that the requirements of the declaration of conformity change as well.

Now don’t be afraid! I have done all the hard work for you. But because it is your product you’re dealing with, I would like you to also have a close look yourself. This will be done in step 2.


To find the directives that
 apply to your product: 

  1. Go to the website of the European Commission
  2. Click on the product group that applies to your product. 
    -> A new page appears with Information about the product group.
  3. Click on the link to open the directive (e.g. the link Directive 2006/42/EC on Machinery). 
    -> A page with links to the different languages and formats of the directive opens.
  4. Select your language and format (e.g. English and pdf). 
    -> The directive opens 

Step #2 Find all information about the declaration of conformity in the directive

To find all requirements and other relevant information: 

  1. Press ctrl+f and type declaration of conformity 
    -> the number of hits is shown. Note: for construction products you should type declaration of performance. For partly completed machinery you should type declaration of incorporation.
  2. Create a table with two columns in a document or spreadsheet.
  3. Copy/paste in the left column the number of the article and in the right column the text which contains “declaration of conformity”. Read the text carefully. Copy/paste all other hits to the table.

Example: DIRECTIVE 2014/28/EU - explosives for civil uses

Article no.

Text

24

To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

Article 5.2

Where compliance of an explosive with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

 


You have now created an overview of all relevant informa
tion regarding the declaration of conformity. Next to the specific requirements on the content, this can also be information about the requirements whether to translate the declaration of conformity or not, to deliver the declaration of conformity with the product, or to draw up a single declaration of conformity for all applicable directives.

Step #3. Download the correct template and draw up your declaration of conformity

Now you are aware of the requirements, it’s time to draw up the declaration of conformity for your product.

In order to do draw up you declaration of conformity: 

  1. Scroll down to the bottom of this page.
  2. Select correct template(s). The pdf will be sent to the email address provided.
  3. Draw up your own declaration of conformity, based on the template provided.

Step # 4. Check if you have met all other requirements

Now you have created your declaration of conformity that meets all content requirements, it is time to check the other requirements. For this, the document you created in step #2 can be used as a checklist. 

Action: check the document you created for other important information about translating the declaration of conformity, the medium to be used et cetera.

That’s all!

Some facts about the declaration of conformity

    • A declaration of conformity is sometimes also called a CE declaration of conformity or EC declaration of conformity
    • Declaration of conformity vs certificate of conformity: A declaration of conformity is not the same as a Certificate of Conformity (CoC). A CoC (or type approval) is granted by a Notified Body to a product that meets a minimum set of regulatory, technical and safety requirements.
    • Declaration of conformity wiki
    • Declaration of conformity fcc

If you gained some value from my post, I’d appreciate a comment or social media share!

Also looking for a compliant user manual?

Useful resources:
List of other useful startup resources
Chemical substances (REACH)
Explosives for civil use
Pyrotechnical articles
Construction products
Personal protective equipment
Toys safety
Ecodesign and energy labelling
Electromagnetic compatibility
Equipment for explosive atmospheresLow voltage
Radio
RoHS
Active implantable medical devices
In vitro diagnostic medical devices
Medical devices
Measuring instruments
Non-automatic weighing instruments
Cableway installations
Gas appliances
Lifts
Machinery
Pressure equipment
Recreational craft and personal watercraft
Simple pressure vessels

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