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Declaration of ConformityCE documentation

# How to Create a Declaration of Conformity (DoC) – With Example

The EU Declaration of Conformity is a legal document that declares your product meets all applicable EU requirements. It is not a formality—it is the document that gives your CE mark legal weight. This guide shows exactly what must be in a valid DoC and how to avoid common mistakes.

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Problem

## The DoC is a legal commitment, not a paperwork formality

Many founders treat the EU Declaration of Conformity as a final checkbox—something to sign and file away after testing is complete. This is dangerous. The DoC is a legal declaration that the product meets all applicable EU requirements. The person who signs it takes personal responsibility for that declaration.

If market surveillance authorities request your technical file and find inconsistencies, missing evidence, or version mismatches, the signed DoC becomes evidence of non-compliance rather than protection against it. The company and the signatory can face fines, product recalls, and personal liability.

The pain point is not creating the document itself. The pain point is ensuring the document accurately reflects a product you can actually defend. This requires completing the technical file, risk assessment, and evidence collection before the DoC is ever signed—not after.

Requirements

## Required elements of a valid EU Declaration of Conformity

The EU Decision 768/2008/EC specifies the required elements. A DoC missing any of these elements may be considered invalid.

01

Name and address of the manufacturer or authorised representative

02

Product identification: type, batch, serial number, or any other element for identification

03

This declaration of conformity is issued under the sole responsibility of the manufacturer

04

Object of the declaration: description of the product to allow unequivocal identification

05

Reference to the applicable harmonised standards or other technical specifications

06

Reference to the conformity assessment procedures used

07

Date and place of signing

08

Name, function, and signature of the person authorised to sign

Process

## How to create a legally valid Declaration of Conformity

01

### Complete the technical file first

Do not draft the DoC until the technical file is complete and internally reviewed. The DoC must reflect evidence that actually exists and describes the product that will actually ship.

02

### List applicable directives and standards

Identify every directive that applies to your product. For each, list the harmonised standards you applied. Verify these standards are current in the Official Journal—do not cite withdrawn standards.

03

### Describe the product unequivocally

Include model numbers, variants, firmware versions, and any other information needed to uniquely identify the product. The description must match the exact configuration that will ship.

04

### Include manufacturer information

List the full legal name and address of the manufacturer. If you use an EU authorised representative, include their information and state that the DoC is issued on their behalf.

05

### Specify conformity assessment procedure

State which module you followed—typically Module A (internal production control) for self-certified products. If a Notified Body was involved, include their identification number.

06

### Sign and date

The DoC must be signed by a person authorised to bind the manufacturer. Include the date and place of signing. The signature creates legal liability for the declaration.

Structure

## Common DoC mistakes and their consequences

### Signing before evidence is complete

The DoC becomes a liability rather than a protection. If authorities request the technical file and it is incomplete, the signed declaration is evidence of non-compliance.

### Listing withdrawn or outdated standards

Citing standards no longer listed in the Official Journal means you lose presumption of conformity. Your DoC may be invalid.

### Product description does not match what ships

Version mismatches between the DoC and actual product are a common audit failure. The DoC must describe the exact configuration sold.

### Missing or incorrect manufacturer information

The manufacturer named on the DoC takes legal responsibility. If this information is incorrect, liability may fall on the wrong entity.

### Not listing all applicable directives

Omitting a directive that applies to your product means the DoC is incomplete and the CE mark is not valid for that scope.

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## Frequently asked questions

### Who can sign the EU Declaration of Conformity?

The DoC must be signed by a person authorised to bind the manufacturer—typically a director, CEO, or someone with delegated authority. If you use an authorised representative in the EU, they may sign on your behalf, but the manufacturer retains responsibility.

### Does the Declaration of Conformity need to be notarized?

No. The EU Declaration of Conformity does not require notarization. It is a self-declaration by the manufacturer. However, it must be signed by an authorised representative and retained with the technical file for 10 years.

### Can I use one Declaration of Conformity for multiple products?

Only if the products are essentially identical in compliance-relevant aspects—same directives, same standards, same design, same risks. If products differ in any compliance-relevant way, they need separate DoCs or a clearly defined product family with documented equivalences.

### What happens if I need to update the Declaration of Conformity?

If standards change, directives are updated, or your product changes in a compliance-relevant way, you must issue a new DoC. Retain previous versions with the technical file to maintain traceability of what was declared when.

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Related guides

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Educational resource only. CE responsibility remains with the manufacturer or authorised representative. Verify current law, standards, and product-specific evidence before signing.