Creating the Declaration of Conformity: Mandatory Content and Template

The EU Declaration of Conformity is the central legal document of CE marking. With it, the manufacturer declares in a legally binding way that the machine meets all requirements of the applicable EU harmonisation legislation. This guide shows which details are mandatory, where the differences between the Machinery Directive and the Machinery Regulation lie, and which mistakes you should avoid.

What is an EU Declaration of Conformity?

The EU Declaration of Conformity (under the Machinery Directive: EC Declaration of Conformity) is a document with which the manufacturer or the authorised representative declares on their own responsibility that a product meets the requirements of all applicable EU legislation. It is the basis for the CE mark.

The Declaration of Conformity must accompany each individual machine or be available wherever the machine is placed on the market. It must be drawn up in the language or languages of the member state in which the machine is made available. The manufacturer must keep the Declaration of Conformity for at least 10 years from the last date of manufacture (Annex II of the Machinery Directive); under the Machinery Regulation (from 20 January 2027) the period runs from the placing on the market (Article 10 of the Regulation).

Mandatory content under the Machinery Directive (Annex II, Part A)

Until 19 January 2027, Machinery Directive 2006/42/EC applies to the placing on the market. The EC Declaration of Conformity under Annex II, Part 1, Section A must contain the following information:

  1. Business name and full address of the manufacturer and, where applicable, the authorised representative
  2. Name and address of the person authorised to compile the technical file (must be established in the EU)
  3. Description and identification of the machinery including generic denomination, function, model, type, serial number and commercial name
  4. Express declaration that the machinery fulfils all the relevant provisions of the Machinery Directive
  5. Where applicable, a reference to other EU directives with which the machinery complies (for example the Low Voltage Directive, the EMC Directive)
  6. Reference to the harmonised standards applied or other technical specifications
  7. Place and date of the declaration
  8. Identity and signature of the person empowered to draw up the declaration

Changes with the EU Machinery Regulation (Annex V)

From 20 January 2027 the requirements of Annex V of Machinery Regulation (EU) 2023/1230 apply. The most important changes compared with Annex II of the Machinery Directive:

Extended product identification

The Machinery Regulation requires a more unambiguous product identification. Besides designation and serial number, a digital product passport may also become relevant.

Digital provision

The Declaration of Conformity may in future be provided digitally (for example as a download via a web link or QR code). A printed version must be provided on request.

Reference to the Regulation instead of the Directive

Instead of Machinery Directive 2006/42/EC, the declaration refers to Regulation (EU) 2023/1230. Note: during the transition period, either the Directive or the Regulation may apply depending on the date of placing on the market.

Obligations for importers and distributors

The Machinery Regulation defines explicit obligations for importers and distributors regarding the Declaration of Conformity for the first time. Importers must verify that a proper declaration exists before they place the machine on the EU market.

Common mistakes in the Declaration of Conformity

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Missing or imprecise standard references: Standards must be stated with their full designation and date of issue (for example "EN ISO 12100:2010", not just "EN ISO 12100").

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Missing signature: The Declaration of Conformity must be signed by an authorised person. A declaration without a signature is legally ineffective.

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Outdated directive references: Check that you cite the current version of the directive or regulation. After 20 January 2027, Directive 2006/42/EC may no longer be referenced.

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Confusion with the Declaration of Incorporation: For partly completed machinery, a Declaration of Incorporation is issued instead of a Declaration of Conformity. It has different mandatory content and must not carry the CE mark.

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Missing translation: The Declaration of Conformity must be available in the official language of the EU member state in which the machine is made available. A declaration in German only is not sufficient for the French market.

Declaration of Conformity vs Declaration of Incorporation

The distinction matters: complete machinery receives an EU Declaration of Conformity and the CE mark. Partly completed machinery (which must first be incorporated into other machinery or assembled with other machinery before it can be used for its intended purpose) instead receives a Declaration of Incorporation under Annex V, Part B of the Machinery Regulation (previously Annex II, Part 1, Section B of the Machinery Directive).

The Declaration of Incorporation carries no CE marking but must state which essential safety requirements have been met and which requirements the final assembler still has to implement. It is supplied with the partly completed machinery together with the assembly instructions.

FAQ

Frequently asked questions about the Declaration of Conformity

What is a Declaration of Conformity?
The Declaration of Conformity is the central legal document of CE marking, with which the manufacturer or the authorised representative declares on their own responsibility that a product meets the requirements of all applicable EU legislation. It is the basis for the CE mark. The declaration must accompany each individual machine or be available wherever the machine is placed on the market.
What mandatory content must a Declaration of Conformity under the Machinery Directive contain?
Under Annex II, Part 1, Section A of Machinery Directive 2006/42/EC the EC Declaration of Conformity must contain, among other things, the business name and full address of the manufacturer, the name and address of the person authorised to compile the technical file, and the description and identification of the machinery. Added to this are the express declaration of conformity, where applicable the reference to other EU directives, the reference to the harmonised standards applied, place and date, and details of the signatory and their signature. The person authorised to compile the technical file must be established in the EU.
What changes for the Declaration of Conformity with the EU Machinery Regulation 2027?
From 20 January 2027 the requirements of Annex V of Machinery Regulation (EU) 2023/1230 apply instead of Annex II of the Machinery Directive. The declaration then refers to Regulation (EU) 2023/1230 instead of Directive 2006/42/EC, requires a more unambiguous product identification and may in future be provided digitally, for example as a download via a web link or QR code. In addition, the Machinery Regulation defines explicit obligations for importers and distributors regarding the Declaration of Conformity for the first time.
How long must a Declaration of Conformity be kept?
Under the Machinery Directive the manufacturer must keep the Declaration of Conformity for at least 10 years from the last date of manufacture of the machine (Annex II of the Directive). Under the Machinery Regulation (from 20 January 2027) the 10-year period runs from the placing on the market of the machine (Article 10 of the Regulation).
What is the difference between a Declaration of Conformity and a Declaration of Incorporation?
Complete machinery receives a Declaration of Conformity and the CE mark, whereas partly completed machinery receives a Declaration of Incorporation instead. Partly completed machinery must first be incorporated into other machinery or assembled with other machinery before it can be used for its intended purpose. The Declaration of Incorporation carries no CE marking but must state which essential safety requirements have been met and which the final assembler still has to implement; it is supplied together with the assembly instructions.
Which mistakes should be avoided in the Declaration of Conformity?
Common mistakes are missing or imprecise standard references, a missing signature and outdated directive references. Standards must be stated with their full designation and date of issue (for example EN ISO 12100:2010 rather than just EN ISO 12100), and a declaration without the signature of an authorised person is legally ineffective. Further mistakes are confusion with the Declaration of Incorporation and a missing translation into the official language of the EU member state in which the machine is made available.

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