If you are involved in writing user manuals, importing products into the EU, or participating in any activity related to placing products in the European market, there’s a high likelihood that you’ll encounter the need for a Declaration of Conformity DoC. This is the crucial final step toward CE-Marking.
In this Blog you will be guided through the process of creating a fully compliant Declaration of Conformity (DoC), so you will be able to compile this document yourself.
Simply follow the steps outlined in the Declaration-of-Conformity-Template-Method, utilizing the provided templates and examples.
Disclaimer: This method does not replace the CE-Marking process; it specifically aids in the final step, drafting the Declaration of Conformity. Our expert can always assist you with the CE marking proces.
Drawing up a Declaration of Conformity
Whether you’re involved in product importation, manufacturing, EU exports, R&D within a company, or are an entrepreneur, safety expert, technical writer, QA manager, or translator, chances are you’ll encounter the need for a Declaration of Conformity.
These legal documents must be seamlessly integrated into user manuals or included with the products you (or your company) sell, or they may be part of the technical file.
Creating the declaration of conformity falls on someone’s shoulders. In the absence of an official safety expert, companies often turn to technical authors or product engineers. If there’s no technical writer or product engineer, the responsibility may fall on you!
If you are struggling with drafting a compliant Declaration of Conformity: Continue reading to discover how to craft a compliant Declaration of Conformity tailored to your specific product.
Origin of the Declaration-of-Conformity-Template-Method
A colleague of ours, equipped with a background in Industrial Design Engineering and immersed in both product development and technical writing, delved into the complexities of compiling Declarations of Conformity driven by a fascination with CE-marking.
If you’ve found yourself spending extensive time navigating the internet in search of the right information—what to include and what to exclude—only to be left with lingering uncertainty, you’re not alone.
In response to this challenge, our colleague has developed a working approach, essentially creating the Declaration-of-Conformity-Template-Method.
By using the method
The information to be included in a EC/EU Declaration of Conformity for a specific product is very clear. Our experts have an excellent example of a Declaration of Conformity for each product group.
And here’s the exciting part—you can do the same! All you need to do is follow the steps outlined below. This method incorporates exemplary instances and templates tailored to each product group that necessitates a Declaration of Conformity. So, if you’re eager to draft compliant Declarations of Conformity, continue reading!
Let’s simplify it into actionable steps.
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.
- Go to the EU site. Select your product group(s).
- Find all the information about the Declaration of Conformity in the Directive or Regulation
- Get the correct template(s) and draw up your Declaration of Conformity
- Check if you have met all the requirements
Warning! This method in no way replaces the CE-Marking process. It solely aids in the final step of this process: drafting the Declaration of Conformity. When needed our experts can assist with the CE-Marking process.
There are 25 product groups that require CE-marking and, consequently, a Declaration of Conformity. If your product falls within one of these product groups, you can compile the Declaration of Conformity.
Many products must comply with multiple Directives and/or Regulations. If this applies to your product, all steps outlined below must be executed for each relevant Directive and/or Regulation.
In some cases, you may not find specific requirements in a Directive or Regulation. For such Directives and Regulations, the following harmonised standard can be used:
- EN-ISO/IEC 17050-1:2014 Supplier’s Declaration of Conformity — Part 1: General requirements.
Compliance with harmonised standards generally presumes conformity with the Directive or Regualtion.
However, if a Directive or Regulation has its own distinct requirements, such as the Machinery Directive or the Radio Equipment Directive, the EN-ISO/IEC 17050-1:2014 can serve as a foundation but must be augmented or modified according to the additional requirements stipulated in the Directive or Regulation.
It’s crucial to note that Directives and Regulations undergo occasional changes. If a Directive and/or Regulation is revised, there’s a significant likelihood that the requirements for the Declaration of Conformity will also change.
Now, rest assured! This blog has taken care of all the intricate details for you. However, since it’s your product (and legally you are responsible for it), it is recommended that you closely examine it as well. This will be addressed in step 2.
Explanation of the steps
First start to find the Directives and Regulations that apply to your product:
- Go to the website of the European Commission.
- From the drop-down menu choose the product group that applies to your product.
- Information about the product group is displayed below.
- Click on the link to open the Directive or Regulation.
- A page with links to the different languages and formats of the Directive or Regulation opens.|
- Select your language and format (e.g. English and pdf).
- The Directive or Regulation opens
To find all requirements and other relevant information:
- 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.
- Create a table with two columns in a document or spreadsheet.
- 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.
You’ve compiled a comprehensive overview of all pertinent information concerning the Declaration of Conformity. In addition to specific content requirements, this may encompass details on whether to translate the Declaration of Conformity, whether to include it with the product, or whether to create a single Declaration of Conformity for all applicable Directives and Regulations.
It’s time to draft the Declaration of Conformity
In order to do so:
- Indicate the template(s) you need on our contact us form.
- If the template is available, our expert will provide the template
- Draw up your own Declaration of Conformity, based on the template provided
Having drafted your Declaration of Conformity to meet all content requirements, it’s now time to check the additional requirements. Utilize the document generated in step #2 as a checklist.
Examine the document for crucial details, such as whether there are specifications about translating the Declaration of Conformity, the preferred medium, and so forth.
That concludes the process!
Find More Insights
Construction Products Regulation 2013
The lifts and safety components of lifts Directive 2014/33/EU
CETA, Trade agreement between the EU and Canada
Personal Protective Equipment (PPE) Regulation EU 2016/425
Full-service product compliance
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