Declaration of Conformity Software for Machinery

The EU Declaration of Conformity is the final, legally binding step of CE marking. This guide explains the role it plays in the CE process, how it differs from the Declaration of Incorporation and how the declaration of conformity module in CE-Copilot supports you in producing a formally complete, multilingual declaration.

What is the EU Declaration of Conformity in the CE marking process?

The EU Declaration of Conformity is the final, legally binding step of CE marking: with it, the manufacturer declares on their own responsibility that the machine meets all applicable directives. It is therefore not a mere form at the end of the process but the legally binding assurance that authorities, customers and market surveillance rely on.

The details the declaration must contain are set out in Annex II of Machinery Directive 2006/42/EC, and in future in Annex V of EU Machinery Regulation 2023/1230. The mandatory details include in particular the manufacturer, the product, the directives and standards applied, the signatory and, where required, details of the notified body.

The Declaration of Conformity comes at the end of the CE process but is closely linked to the preceding steps: the standards and directives it cites must match the results of the standards research and the risk assessment. A coherent declaration therefore presupposes that the technical documentation is maintained consistently.

Declaration of Conformity vs Declaration of Incorporation

Not every declaration is a full Declaration of Conformity. The Machinery Directive distinguishes two document types, depending on the kind of machinery:

The full Declaration of Conformity (Annex II 1.A) applies to ready-to-use machinery. With it the manufacturer confirms full conformity, and only on its basis may the CE mark be affixed.

The Declaration of Incorporation (Annex II 1.B), by contrast, applies to partly completed machinery, which only becomes ready for use after incorporation into another machine or installation. Such partly completed machinery carries no CE mark under the Machinery Directive and additionally requires assembly instructions. The correct declaration type therefore depends directly on whether the machine can be used for its intended purpose on its own.

The declaration of conformity module in CE-Copilot

Below you see the central features, each with its concrete advantage and the benefit for your daily work.

Feature

Guided form with all mandatory fields per Annex II/V

Advantage

The module guides you through all prescribed fields: manufacturer, product, directives and standards applied, signatory and, where applicable, notified body. For Annex IV or high-risk machinery, the procedure switch guides you through the choice of conformity assessment procedure (Article 12 of the Machinery Directive or Article 25 of the Machinery Regulation) and makes the notified body details mandatory depending on the procedure chosen. Automatic validation flags missing mandatory fields and issues warnings before you export.

Your benefit

You forget no mandatory detail and receive a formally complete declaration: no more risk that a missing detail makes your CE marking formally contestable.

Feature

Automatic standards import and directive selection by checkbox

Advantage

The standards applied are taken directly from the project's standards checklist. You select the applicable directives (Machinery Regulation, Machinery Directive, LVD, EMC, ATEX, PED) by checkbox, without typing out standard and directive numbers by hand.

Your benefit

You transfer your standards list into the declaration consistently and without errors, and ensure that the standards cited match your actual basis of conformity.

Feature

Multilingual export in German, English, French and Italian

Advantage

You export the finished declaration as PDF and Word in German, English, French or Italian, as you choose.

Your benefit

You deliver the declaration in the official language required in the country of destination, without maintaining separate translation templates.

Feature

Digital signature and company logo in the document

Advantage

You capture the signatory's digital signature in a drawing field; the uploaded company logo is embedded in the finished document.

Your benefit

You get a signed, branded declaration in one step, without printing, signing and scanning again.

Feature

Declaration of Incorporation for partly completed machinery and notified body details

Advantage

Besides the full Declaration of Conformity, you also create the Declaration of Incorporation for partly completed machinery. Notified body details (identification number and authorised representative) can be added specifically.

Your benefit

You also cover partly completed machinery and cases subject to conformity assessment correctly, with the right type of declaration instead of a one-size-fits-all template.

Feature

Pre-filled from the standards finder and risk assessment, saved and manageable

Advantage

The declaration is pre-filled from the standards finder analysis and the risk assessment. Declarations you create can be saved, loaded, edited and managed.

Your benefit

You reuse existing project data without double entry and keep all declarations for your machines in one place, ready for audit.

Who benefits from the declaration of conformity module?

SMEs & machine builders

No template of your own needed: the platform provides the structure per Annex II/V.

Series machinery & product lines

Maintain master data once; per production lot only add the serial-number range and year of construction. One declaration covers whole number ranges.

Special-purpose machinery

One declaration per machine with its serial number, every mandatory field guided.

External CE consultants

Declaration of Conformity in your client's branding, generated per client.

In detail per audience: CE software by audience

Create your EU Declaration of Conformity with guidance now

Create your EU Declaration of Conformity with all mandatory fields per Annex II/V, with automatic standards import, digital signature and multilingual PDF and Word export. Cancel monthly, no annual subscription.

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