What Is A Declaration of Conformity?

by | Dec 17, 2023 | Authorised Representative, Declaration Of Confirmity

Declaration of Conformity

A Declaration of Conformity is a very important, mandatory legal document which is to be created for every CE marked product that is sold in the EU. It is a signed statement, stating that a product meets the safety requirements as set out in the European Directives and / or Regulations.

The declaration of conformity serves as a legal statement from the manufacturer which confirms that their product is compliant with the relevant directives and regulations. A valid declaration of conformity is a requirement for CE marking.

It is a declaration by the manufacturer that their product is safe, adheres to all of the regulations and is fit to be put on sale in the European Union. Every product covered by CE marking Directives needs one of these, and the process leading up to generating one can be long and complicated, meaning that an expert eye is often needed.

How long is a Declaration of Conformity valid for?

Once issued, a declaration of conformity is valid for an indefinite period. This is only if the product’s design and intended use remain unchanged and the relevant directives and standards are not revised.

If the product is updated, or if the EU standards are updated, then you must complete a new declaration of conformity to replace the existing document.

What does a Declaration of Conformity mean?

When selling products in the EU, you need to check whether or not they come under any European Product Directives; examples of which are:

Most Directives require a CE mark but there are other marks too. These marks show that the item meets specific safety requirements set out in the Directives. It is also complicated a little further in that some CE marked products, such as Construction Products, use a ‘Declaration of Performance’ rather than a ‘Declaration of Conformity’ but the approach to their creation lies along similar lines.

A number of checks will need to be made to ensure that the product is safe, and various pieces of paperwork will need to accompany it, including the Declaration. This Declaration is the official document in which the manufacturer of the product is declaring, by the act of signing it, that the product complies with the essential requirements of any applicable European Directives.

The Declaration should take the form of a single document where it is outlined which CE marking Directives the product complies with. This Declaration needs to be issued before the product is placed on the market and it must be drawn up in one of the official languages of the European Union.

The length of time that a Declaration of Conformity is valid is for ten years after the date of the final production of the item and must be kept available. Note that the Declaration is also a live item and is to be updated (along with its supporting evidence that is contained in the technical file) when any important changes are made to the product itself, or the legislation which the product comes under changes.

What must the document state?

A valid declaration of conformity will include the following information:

  • The name and address of the manufacturer
  • The name and address of their authorised representative partner
  • A product description including the model number and serial number
  • A statement which confirms the product complies with the required directives and legislation
  • Details of any notified bodies involved in the conformity assessment process, this may not be applicable for declarations of conformity
  • Where applicable, a reference to the harmonised standards
  • Where applicable, reference to other standards and technical specifications used
  • The place and date of the declaration
  • The date and signature of the authorised representative

Whilst the DoC demonstrates a product’s compliance it is not a guarantee of safety or quality.

For imported products, the importer must ensure that the product is accompanied by the declaration of conformity and must retain a copy of this for 10 years from the date of placing the product on the market.

Additionally, the EU declaration of conformity must be translated into the language(s) required by the EU country in which the product is sold.

What products require a Declaration of Conformity?

An EU declaration of conformity is required to trade and market your product within the European Union. Products within the following categories require a DoC:

If multiple CE marking directives are applicable for one product, the manufacturer or authorised representative must issue a declaration of conformity for each directive. For example, if your product is required to comply with five directives, this means five DoCs must be issued.

Can I create my own Declaration of Conformity?

Under no circumstances should you create your own declaration of conformity unless you thoroughly understand the document, directives, regulations and industry standards.

If you create your own DoC which isn’t completed to the required standards, you are putting your products at risk of being removed from the EU market.

Are DoC’s verified?

Once presented to the authorities, the DoC will be inspected for any obvious signs of forgery or tampering and to ensure that this is a legitimate document. Before submitting your DoC, you should carefully review the formatting, spelling and any irregularities as these are signs that could flagged by the authorities.

What are the language requirements for the Declaration of Conformity?

A declaration of conformity must be completed in one of the official languages of the European Union. However, the EU member states may require that the DoC is translated into their official language before being submitted.

The CE marking directives do not specify who has the obligation to translate but it makes sense for this to be the manufacturer to translate the document.

When must a Declaration of Conformity be shown?

A Declaration of Conformity will need to exist for and (dependent upon the Directive it is in scope of) supplied with any new product that is to go on sale in the European Union. This Declaration should follow the supply chain from manufacturers through to end-users to show that it meets all of the requirements stipulated in the Directives and / or Regulations.

One exception where the Declaration does not need to be supplied to the end-user is electrical equipment which falls under the Low Voltage Directive. This will still need a Declaration of Conformity to be drawn up by the manufacturer or authorised representative, but it does not need to be actually supplied to the end user.

What to do with a Declaration of Conformity

The Declaration will need to be passed down the supply chain so that the end user can receive a copy of it. This means that it will need to be forwarded from the manufacturer down to any suppliers and distributors who might be handling the product.

Any product needing a CE mark which does not have a Declaration of Conformity will need to have one drawn up before it can be supplied anywhere else.

The purchaser of the item should retain this Declaration so that they are able to prove that the product complied with all of the relevant Directives when it was first placed onto the EU market. This will show that they have done their duty in terms of ensuring that the product that they either supply or put into use is safe.

The manufacturer and authorised representative should keep the Declaration of Conformity on file for at least ten years from the date that the product is placed on the market.

Can you get CE marked without a Declaration of Conformity?

Without a declaration of conformity, you cannot get CE marking for your products. The DoC is a legal requirement that confirms a product meets the required standards and is therefore eligible for CE marking.

If you affix a CE mark without a declaration of conformity or place your products on the EU market without a DOC, you can face significant penalties.

How to achieve a Declaration of Conformity

The Declaration of Conformity must be issued by the manufacturer. If the manufacturer is not based within one of the European Union members states, then it must have an EU-based Economic Operator (e.g. an Authorised Representative) in place in order to sell it in the EU. Depending upon the Directives used, this Authorised Representative is required to be named on the Declaration. You will need to know what Directives your product falls under and will then need to be meticulous in ensuring that your product meets all of the requirements within those Directives.

In some cases, this may require the product to go through testing or assessment, and may need Notified Body involvement. This will then enable you to pull together a technical file with all the details about the product and the results of any testing that it has been subjected to.

Once all of this has been satisfied, the CE mark can be attached to the product and the Declaration of Conformity can be drawn up.

What happens if you don’t have a valid DoC?

If you are found to have an invalid or non-compliant DoC the following actions could be taken:

  • Customs holds/inspections which can lead to lengthy delays
  • Supply chain disruption from refused entries and delays
  • Fines
  • Seizure of goods
  • Additional audits to ensure full compliance in the future

The relationship between UKCA/CE marking and DoC

The EU declaration of conformity and the UKCA/CE marking are two sides of the same coin but serve distinct legal purposes:

  • UKCA/CE marking: It’s a physical symbol affixed to your product, its data plate or packaging to highlight its compliance
  • DoC: This is the document that proves and justifies the UKAC/CE mark

Common DoC mistakes to avoid

  • Using the wrong or incomplete address
  • Referencing the wrong standards
  • Confusing a Certificate of Conformity and Declaration of Conformity
  • Not signing documents or missing deadlines
  • Using placeholder text rather than text that is specific to your product
  • Confusing UKCA & CE requirements
  • Failing to update the DoC inline with regulation changes or product changes
  • Not translating the DoC

Certificate of Compliance (CoC) v Declaration of Conformity (DoC)

A DoC is a legal document that is issued by the importer or manufacturer who places the product on the market. Issuing a DoC is mandatory when importing or manufacturing products that require a CE mark.

However, a CoC is issued by a third party and is a document of assurance that the product meets the legal or industry-specific requirements.

Get in Touch

A Declaration of Conformity can be a difficult document to put together, and there are a lot of steps to go through before that can even be done. It is important that the document is correct, or the item cannot be put on sale.

Our Authorised Representatives can advise on what they are looking for, and can act as your representative within the EU, ensuring that everything is done correctly and that your product can legally be put on sale. Please get in touch with us today to find out more about how we can help you.