The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.
If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:
- prepare the technical documentation before placing a product on the market
- ensure the technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market
- keep the technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise)
The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an EU declaration of conformity. You need this documentation in order to affix the CE marking to the product.
How to draw up the technical documentation?
The technical documentation should include at least:
- your name and address, or those of any authorised representatives
- a brief description of the product
- identification of the product, for example, the product's serial number
- the name(s) and address(es) of the facilities involved in the design and manufacture of the product
- the name and address of any notified body involved in assessing the conformity of the product
- a statement of the conformity assessment procedure that has been followed
- the EU declaration of conformity
- label and instructions of use
- a statement of relevant regulations to which the product complies
- identification of technical standards with which compliance is claimed
- list of parts
- test results
As a manufacturer, you should be able to demonstrate where and how the various parts of the document are held and maintained.
You can usually choose in which language you want to prepare the technical documentation. However, the market surveillance authorities may ask you to translate the technical documentation depending on the EU country where the product has been placed on the market. If requested, you can also provide it in electronic format.
Risk assessment
As a manufacturer, you are responsible for identifying all the possible risks your product could pose and determine the applicable essential requirements. This analysis must be included in the technical documentation. In addition, you will need to explain the ways in which you have addressed the risks identified to ensure that your product complies with the applicable requirements, for example, by applying harmonised standards.
EU declaration of conformity
An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.
How to draw up a declaration of conformity
As a manufacturer, it is your responsibility to draw up the EU declaration of conformity(DoC). It should contain the following information:
- your name and full business address or that of your authorised representative
- the product's serial number, model or type identification
- a statement, stating you take full responsibility
- means of identification of product allowing traceability – this can include an image
- the details of the notified body which carried out the conformity assessment procedure (if applicable)
- the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
- your name and signature
- the date the declaration was issued
- supplementary information (if applicable)
For imported products, the importer must ensure that the product is accompanied by the DoC and must keep a copy of it for 10 years after the product has been placed on the market.
You must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.
FAQs
How to create a Declaration of Conformity?
- Select a relevant product group on the website of the European Commission.
- Read about the Declaration of Conformity in the content of each applicable Directive.
- Draw up the DoC.
- Recheck if the Declaration of Conformity you've drawn meets all the requirements.
Contact Regulatory Authorities
Depending on the region and product type, you can contact relevant regulatory authorities or Notified Bodies (NoBo's) to inquire about the validity of the DoC. They may have databases or information to confirm the authenticity of the document.
What is the requirement in the EU Declaration of Conformity? ›
a brief description of the product. identification of the product, for example, the product's serial number. the name(s) and address(es) of the facilities involved in the design and manufacture of the product. the name and address of any notified body involved in assessing the conformity of the product.
How to get CE Declaration of Conformity? ›
How do I get a Declaration of Conformity?
- Identify the EU requirements for your product.
- Check whether your product meets the specific requirements.
- Check whether your product must be tested by a Notified Body.
- Test your product.
- Compile the technical dossier.
- Affix the CE marking and draft a declaration of conformity.
A statement of conformance is an expression that describes the conformance or non-conformance of an item to a specification or standard. Examples of statements of conformity are pass or fail, in tolerance or out of tolerance, or in spec or out of spec.
Why do I need a Declaration of Conformity? ›
It is a sign that a product has been designed and constructed for compliance with relevant essential requirements, and has been through the appropriate conformity assessment processes. A Declaration of Conformity is not a quality certificate, nor a guarantee for safety.
Is CE certification accepted in the USA? ›
However, the CE mark does not apply in the United States, and electronic devices that have received CE certification cannot legally enter the United States market without also passing testing for US electrical compliance regulations. The United States has its own regulatory framework for electronic devices.
How do I get a US certificate of conformity? ›
How To Get A Certificate Of Conformity
- Find Out Which Legal Requirements Apply. At first you need to find out the legal requirements for selling the products in the market you are importing to. ...
- Carry Out A Risk Assessment And The Appropriate Tests. ...
- Get All The Documents You Need.
The EC Declaration of Conformity must be kept at least ten years after the last date of manufacture of the product, unless the directive or regulation expressly indicates another term.
Can I make my own certificate of conformity? ›
You are not required to, but you may copy the layout and title the document "General Certificate of Conformity" and include the details pertinent to your product; or, if you prefer, you may create your own form, as long as it captures all of the requirements listed in 16 CFR 1110.11.
CE Mark Self Certification or CE Certification Self Certification is an option for some manufacturers, depending on their product. Some examples of product groups directives for which manufacturers can self-certify include: Safety of Machinery Directive.
What is the difference between a CE certificate and a Declaration of Conformity? ›
A CE certificate is provided by a Notified Body after an extensive evaluation, whereas a Declaration of Conformity is based on the manufacturer's self-assessment.
Who can issue a CE Declaration of Conformity? ›
Manufacturers play a vital role in ensuring that products placed on the extended single market of the EEA are safe. It is their responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity and affix the CE marking to a product.
Where can I get an EC Declaration of Conformity? ›
The Declaration of Conformity must be issued by the “manufacturer” or their “authorised representative”. However, this is not necessarily the person or company who actually made the product.
