CE im Anlagenbau Arbeitshilfen für Konformität und Maschinenverordnung

Articles

Declaration of Incorporation or EU Declaration of Conformity? The Difference Explained

Not every component built into an industrial plant receives a CE mark. Whether a declaration of conformity or a declaration of incorporation is required depends on a single distinction: complete versus partly completed machinery.

Matthias Meyer,

Complete and partly completed machinery

Under the Machinery Directive 2006/42/EC, a partly completed machine is an assembly which almost constitutes a machine but cannot in itself perform a specific application. It is intended solely to be incorporated into or assembled with other machinery. Typical examples:

  • industrial robots without a specific application
  • drive systems
  • combustion engines
  • a plant with a missing safety guard
  • a machine without a control system

Only complete machines receive a CE mark and an EU declaration of conformity. Partly completed machines receive a declaration of incorporation, and no CE mark.

The manufacturer's obligations

Under Article 13 of the Machinery Directive, the manufacturer of a partly completed machine must ensure, before placing it on the market, that three things are in place:

  1. the relevant technical documentation (Annex VII Part B)
  2. assembly instructions (Annex VI)
  3. a declaration of incorporation (Annex II Part 1 Section B)

The assembly instructions and declaration of incorporation accompany the machine until it is incorporated, then become part of the technical file of the complete machine.

Free movement without a CE mark

A partly completed machine may still be placed on the market throughout the EU (Article 6), provided the declaration of incorporation clearly states that it is intended for assembly with other machinery and is drawn up according to Annex II Part 1 Section B.

The declaration of conformity

At the end of the conformity procedure for a complete machine stands the EU declaration of conformity. It confirms that the product meets all relevant requirements and includes, among other things, the manufacturer's details, the product description, the directives applied and the standards complied with.

Editable Word templates for both declarations are available as a free download on the German templates page (currently in German only). The full procedure is covered in the e-book CE marking in plant engineering.

This article is a technical working aid. It does not replace reading the legal texts or individual advice.