There are two commonly used declarations by product manufacturers and each has an important but very different role.
Declaration of Incorporation (DoI)
This is used where the manufacturer is unable to sign a Declaration of Conformity because the product is incomplete and is designed to be incorporated into another apparatus by another manufacturer which will then be CE marked before it is supplied to an end-user.
A DoI should show compliance with the relevant essential requirements of the Machinery Directive. The Machinery Directive is the only legislation that allows a DoI. The final manufacturer will take care of the CE Marking process and issue a Declaration of Conformity for the final equipment which is to be placed on the EU market.
Declaration of Conformity (DoC)
This is a document which states that the product complies with the essential requirements of the relevant Directives and Regulations and that the CE Marking process has been correctly followed. It must be signed by someone with suitable authority within the company making the declaration. Normally, it is the company placing the product on the EU market. It is legally binding upon the company once signed.
A DoC is an important legal document for four reasons:
- It shows to any person that the manufacturer has correctly followed the CE Marking process and that the product is compliant with the appropriate legislation.
- It clearly shows the legislations and standards that have been applied to the products.
- It can be used by Customs to check if the product is suitable to enter the EU.
- If in the event of a product problem such as a safety incident or product recall the authorities will check the DoC and its contents. If an incorrect or wrong declaration has been made then this will be considered as part of the corrective actions to be taken which could include legal action as well as recalls, withdrawal from the market, and reworks.
Some Directives such as the Machinery Directive require a copy of the EU DoC to be supplied with the product. Others such as the Radio Equipment Directive just require a short version to be included with the product information and a link to a website where it can be viewed.
The definition of a DoC is given in Article 5 of Regulation 768/2008 and shows the information to be included:
Where Community harmonisation legislation requires a statement by the manufacturer that fulfillment of the requirements relating to a product has been demonstrated (EC declaration of conformity), the legislation shall provide that a single declaration shall be drawn up in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates, and giving the publication references of the acts concerned.
Declaration of Conformity Format
The DoC format is shown in Annex III of Decision No 768/2008/EC as to what specific information should be included. It should be a single document covering all the relevant legislation.
Some Directives may also require additional specific information to be included, but a DoC should always contain the following:
- Product identification
- Name and address of the manufacturer, or their Authorized Representative. From July 2021 this requirement is modified by Regulation 2019/1020 so there must be a presence in the EU. This is so that the authorities have an EU contact they can come to in the event of any issues arising with the product.
- The wording ‘This declaration of conformity is issued under the sole responsibility of the manufacturer or Authorised Representative’.
- Traceability information (i.e. serial number range, date code range, photographs, etc.)
- The wording ‘The object of the declaration described above is in conformity with the relevant Community harmonisation legislation:’
- References to the standards and specifications used to show compliance including issue dates.
- If a Notified Body has been used in the Conformity process then its details should be included.
- Place and date of issue.
- Name and job function of Signatory.
- Signature of the person responsible. This should be a senior position within the company.
The DoC is a single document. To cover all the EU languages, it must be produced in one of the official languages of the EU and then can be accompanied by translations that are not required to be signed.
The DoC should apply to all the legislation relevant to the product. Sometimes manufacturers split this into several documents i.e. for Safety, EMC, and RoHS and this is not correct.
It should be included in the products technical file and updated as necessary taking into account changes in production, Directives, Regulations, and Standards that can and do occur often.
Normally a DoC is printed on a company’s letterhead paper.
Declaring Product Conformity
Declaring conformity is not a difficult stage of the CE Marking process; however, you must be aware of what you are doing from a legal perspective. Completing this step essentially means that you are signing a contract with the entire EU.
Properly securing a CE Marking is imperative for any product destined for the EU market.
Click below to learn more about CE Marking and discover detail about what is involved in the process.