What Is a Declaration of Conformity?

Every product that enters the European market under a CE marking directive must be accompanied by a Declaration of Conformity. It is the single most important compliance document a manufacturer signs — and yet most first-time importers and SME manufacturers cannot answer three basic questions: what it is, what it must contain, and who is legally responsible for signing it.

This guide answers all three.

What Is a Declaration of Conformity?

A Declaration of Conformity (DoC) is a legally binding document in which the manufacturer — or their authorised representative — declares that a product meets all applicable EU health, safety, and environmental requirements. It is not a certificate. It is not a test report. It is a formal statement of responsibility, signed by a named individual with the authority to commit the company.

Under EU law, the DoC is the document that makes CE marking valid. Without a correctly completed and signed DoC, a product cannot legally carry the CE mark — even if it has passed all required testing.

Who Needs a Declaration of Conformity?

Any manufacturer, importer, or authorised representative placing a product on the EU market that falls under one or more CE marking directives must issue a DoC. The most common product categories are:

• Electrical and electronic equipment (Low Voltage Directive, EMC Directive)
• Machinery (Machinery Regulation)
• Medical devices (MDR)
• Toys (Toy Safety Directive)
• Personal protective equipment (PPE Regulation)
• Construction products (CPR)
• Radio equipment (RED)
• Pressure equipment (PED)
• Measuring instruments (MID)
• Gas appliances (GAR)

If your product is not covered by any CE marking directive, you do not need a DoC. If it is covered, you need one — before the product reaches the EU border.

What a Declaration of Conformity Must Include

A valid DoC must contain, at minimum, the following elements as required by the EU's NLF (New Legislative Framework):

1. Product identification. A unique reference that allows traceability — typically the product name, model number, serial number, or batch identifier. This must be specific enough that the DoC can be matched to the exact product it covers.

2. Manufacturer's name and address. The legal entity responsible for the product. If the manufacturer is outside the EU, the DoC must also include the name and address of the authorised representative within the EU.

3. Statement of sole responsibility. A sentence declaring that the DoC is issued under the sole responsibility of the manufacturer. This is legally significant — it establishes who carries the liability.

4. Object of the declaration. A description of the product that allows traceability back to the DoC. This can include a colour image if helpful, but must be unambiguous.

5. Applicable EU legislation. A list of the specific directives and regulations the product complies with. For example: "2014/35/EU (Low Voltage Directive), 2014/30/EU (Electromagnetic Compatibility Directive), 2011/65/EU (RoHS Directive)." Vague references such as "applicable EU legislation" are insufficient.

6. Harmonised standards and technical specifications. The specific standards the product was tested against — e.g. "EN 62368-1:2020 (Audio/video and IT equipment safety)" — and the dates or versions of those standards.

7. Notified body details (if applicable). If a Notified Body was involved in the conformity assessment, their name, identification number, and the certificate reference must be stated.

8. Signatory details. The name, position, and signature of the person authorised to sign on behalf of the manufacturer. The date and place of signature must also be included.

Declaration of Conformity vs. Certificate

A common mistake: treating a CE certificate from a test lab as a replacement for a DoC. They are different documents serving different purposes.

	Declaration of Conformity	Certificate
Who issues it?	The manufacturer (or authorised representative)	A third party — test lab, Notified Body, certification body
What it proves	That the manufacturer takes responsibility for compliance	That the product passed specific tests
Legal weight	Mandatory — no CE marking without it	Supplementary — supports the DoC but does not replace it
Examples	CE DoC, UKCA DoC, FCC DoC	EN 62368-1 test certificate, EMC test report

A manufacturer can have a stack of test certificates and still be non-compliant if the DoC is missing, incorrectly completed, or unsigned.

Who Signs It — and Who Carries the Liability

The DoC is signed by a named individual within the manufacturer's organisation — typically a director, quality manager, or compliance officer with delegated authority. That individual is not personally liable in most legal systems, but their signature binds the company.

The company — not the individual signatory — carries the legal and financial liability. If a product is found to be non-compliant, the manufacturer faces enforcement action. The signed DoC is the prosecution's primary evidence: the manufacturer declared, in writing, that the product was compliant.

How Long to Keep It

The DoC must be kept for 10 years after the last unit of the product is placed on the market (or longer if specified by the applicable directive). It must be made available to market surveillance authorities on request — typically within days, not weeks. An expired or misplaced DoC is treated as non-compliance.

The Digital Alternative

A PDF DoC sitting in a shared drive satisfies the legal requirement — technically. But it introduces practical risks. A PDF cannot be independently verified. A PDF does not tell a customs officer or a buyer whether it is the current version. A PDF cannot be updated when the applicable standards change without re-issuing and re-distributing.

Sustalium publishes Declarations of Conformity as live, hashcode-verified public pages. The DoC lives at a permanent URL with a QR code. A customs officer scans the QR code on the shipping documents and sees the current declaration — not a PDF attachment from six months ago. When a harmonised standard is updated, the declared fields are flagged, and one update propagates across every published document. The DoC at https://sustalium.com/compliance/ce-mark-doc/ uses the Generator framework — structured fields for manufacturer details, applicable directives, standards references, and signatory data. Enter your data once and publish.

Get started now →

€10 per document per month. No setup fees. No annual contracts.

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Frequently Asked Questions

Do I need a different DoC for each product model?

Yes. The DoC must uniquely identify the product it covers. Variations of the same model (different colours, sizes within the same design) can often be covered by one DoC if the technical documentation demonstrates that the variations do not affect compliance. A different model with different technical characteristics requires a separate DoC.

Can I write my own Declaration of Conformity?

Yes. For most product categories, the manufacturer can self-declare conformity without involving a third party. This is called "self-certification" or "Module A" conformity assessment. You are responsible for ensuring your technical documentation supports the declaration.

What happens if my DoC is incorrect?

Market surveillance authorities can require you to correct it. If the product is non-compliant, they can order a withdrawal or recall. Falsely declaring conformity is a criminal offence in most Member States.

Do we need a DoC for Great Britain after Brexit?

Great Britain requires a UKCA Declaration of Conformity (functionally similar to a CE DoC but referencing UK legislation). Northern Ireland requires both UKCA and CE marking under the Windsor Framework.