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EC declaration of conformity: content and obligations
The EC declaration of conformity is the document through which a manufacturer assumes legal responsibility. It accompanies every machine placed on the European market and attests that the equipment complies with the applicable essential requirements. Without it, the CE marking cannot be affixed.
What is the EC declaration of conformity?
It is a statement signed by the manufacturer, under its sole responsibility, affirming that the machine meets the requirements of Machinery Directive 2006/42/EC, and of Regulation (EU) 2023/1230 from 20 January 2027.
Unlike the technical construction file, which remains confidential, the EC declaration of conformity is handed over to the purchaser with the machine. Along with the instructions for use, it is the only regulatory document the end customer systematically receives.
For the majority of machines, it is not issued by any external body. The manufacturer draws it up and signs it.
Mandatory content of an EC declaration of conformity
Annex II of the Machinery Directive sets out the information that any compliant declaration must include:
Identification of the manufacturer
Business name and full address of the manufacturer and, where applicable, of its authorised representative established in the European Union.
Identification of the person authorised to compile the technical file
Name and address of the authorised person, who must be established in the European Union.
Description and identification of the machine
Generic denomination, function, model, type, serial number, commercial designation.
Reference to the legislation applied
An explicit statement that the machine complies with the relevant provisions of the Machinery Directive and, where applicable, of other applicable European directives (low voltage, electromagnetic compatibility, etc.).
Harmonised standards used
A list of the standards applied in the design of the machine.
Where applicable, the notified body
Name, address and identification number of the body, together with the number of the EC type-examination certificate, for machines covered by Annex IV.
Place and date of the declaration
Identity and signature of the signatory
The person empowered to bind the manufacturer.
Who can sign the EC declaration of conformity?
A person with the authority to legally bind the manufacturer. In practice, the company director or a person holding a formal delegation of authority.
The signature engages the civil and criminal liability of the company. An unauthorised signatory does not render the declaration void, but exposes the company in the event of an inspection or dispute.
Manufacturers established outside the European Union must appoint a European authorised representative and name them in the declaration.
EC declaration of conformity and declaration of incorporation: don't confuse the two
These two documents address different situations.
EC declaration of conformity
The EC declaration of conformity concerns complete machinery, ready for use, which can be put into service as it stands.
Declaration of incorporation
The declaration of incorporation concerns partly completed machinery, a sub-assembly intended to be integrated into a larger machine, which cannot operate independently. It comes with assembly instructions and states that the partly completed machinery must not be put into service until it has been incorporated into machinery declared to be in conformity.
Confusing the two is a common mistake among integrators and manufacturers of industrial sub-assemblies.
How long must the EC declaration of conformity be kept?
The manufacturer must keep a copy of the declaration for at least ten years from the date of manufacture of the last unit of the machine. It is generally archived together with the technical construction file, to which it refers.
In the event of a business transfer, this retention obligation passes to the acquirer.
What changes with Regulation (EU) 2023/1230
From 20 January 2027, the EC declaration of conformity becomes the EU declaration of conformity. The terminology changes; the underlying logic remains the same.
Two concrete changes for manufacturers:
The declaration may be supplied in digital format, provided that the user can access it on a lasting basis and that a link or access code accompanies the machine.
Machinery falling within the new high-risk categories will have to refer to the certificate issued by the notified body, in accordance with the Regulation's revised list.
Machinery placed on the market before 20 January 2027 remains covered by its existing EC declaration of conformity.
Common mistakes in an EC declaration of conformity
A generic declaration that does not state the serial number or the precise designation of the machine concerned.
Harmonised standards listed without actually having been applied: the declaration binds the manufacturer to what it asserts.
A signatory without a documented delegation of authority.
The omission of the person authorised to compile the technical file, a mandatory entry that is frequently forgotten.
A declaration drawn up before the technical file has been finalised: the order of the steps matters, and the declaration comes last.
How LCSI supports your declarations of conformity
LCSI writes and structures the regulatory documentation that accompanies your machines: technical construction file, instructions for use, and EC declaration of conformity.
We work either from scratch or by taking over existing documents, with a consistency check across the set: references, designations and the standards cited must match from one document to the next.
We work alongside your technical teams and, where relevant, with your partners specialising in risk assessment.
Writing and structuring the regulatory documentation
Working from scratch or by taking over existing documents
Working alongside your technical teams