Declaration of Conformity preparation or correction

The EU declaration of conformity is the document in which the manufacturer states that fulfilment of the applicable requirements has been demonstrated. Decision No 768/2008/EC, Article R10, says that by drawing it up the manufacturer assumes responsibility for the compliance of the product. Annex III of that Decision sets out the model structure.

For machinery placed on the market under Directive 2006/42/EC, Annex II, part 1, section A, is the EC declaration of conformity, and section B is the declaration of incorporation for partly completed machinery. Regulation (EU) 2023/1230 applies from 20 January 2027 (Article 54). Until that date, Directive 2006/42/EC remains applicable. Annex V of the Regulation is therefore not yet the applicable rule, and it covers only machinery and related products within its scope.

The declaration is issued under the sole responsibility of the manufacturer. It identifies the product for which it was drawn up and is kept with the technical documentation. An authorised representative does not become responsible for the product merely by being named: the mandate has to provide for the task.

A declaration summarises the responsible party's conformity statement where one is required. It does not replace the supporting evidence.

The model in Annex III of Decision No 768/2008/EC contains, in substance, the following particulars.

• A unique identification of the product.
• The name and address of the manufacturer and, where applicable, of the authorised representative.
• A statement that the declaration is issued under the sole responsibility of the manufacturer.
• An identification of the object that allows traceability.
• The relevant Union harmonisation legislation.
• The harmonised standards or other specifications in relation to which conformity is declared, including which parts were applied if application is partial.
• Where the procedure requires it, the notified body, what it did, and the certificate.
• Place and date, and the name, function and signature of the person signing for the manufacturer.

These are general patterns, not a finding about a particular file.

• The product identification is too vague to trace the model that was placed on the market.
• An act is cited that does not provide for this kind of declaration.
• Standards are listed without saying which parts were applied.
• The signatory is not the manufacturer and no mandate covers the signature.
• One text is used for several products that are not the same model.
• Partly completed machinery carries a full declaration of conformity instead of a declaration of incorporation.

• What is the exact type, model, batch or serial identification?
• Who is the manufacturer named on the product, and is there a written mandate for an authorised representative?
• Which Union acts and which standards are intended to be cited?
• Is the product complete machinery, partly completed machinery, or neither?
• Was a notified body required, and if so which certificate exists?
• Who is proposed to sign, and in what function?

Not every product requires an EU declaration of conformity. Do not create a generic EU declaration for products solely because they fall under REACH, WEEE or the GPSR. Check the actual declaration requirements. The PPWR has its own conformity-documentation framework.

Machinery documentation must use the declaration type that matches the applicable legal framework. Under Decision No 768/2008/EC, Article R10, the declaration is continuously updated. It is translated into the language or languages required by the Member State in which the product is placed on the market.

The obligations depend on the product and on the applicable act. The rules of the Machinery Directive, the Low Voltage Directive 2014/35/EU and the Radio Equipment Directive 2014/53/EU, including CE marking where the applicable text provides for it, are separate from Regulation (EU) 2023/988 on general consumer-product safety. There is no CE marking under that Regulation.