Declaration of Conformity explained: what it is, EC vs EU, and how to get one

A Declaration of Conformity (DoC) is a signed document in which a manufacturer, or the party responsible for placing a product on the market, declares on its own responsibility that the product meets every piece of legislation that applies to it. In the EU it is the document behind CE marking: the CE mark on the product is the visible claim, and the DoC is the accountable record that backs it. You will also see it called a declaration of conformance, a CE declaration, or an EC or EU declaration of conformity; these are all the same document. This guide explains what a DoC means, where the EC and EU labels come from, how it relates to CE marking, how you get one, what it must contain, and how it differs from a supplier’s Certificate of Conformance.

What is a Declaration of Conformity?

A DoC is a self-declaration. No authority issues it: the manufacturer draws it up, signs it and takes legal responsibility for what it says. It states that a specific, identifiable product conforms to the named directives or regulations, and it lists the harmonised standards or other technical specifications used to demonstrate that. It has to be kept available for the market surveillance authorities, generally for ten years after the product was placed on the market, and updated whenever the product, the legislation or the standards behind it change.

One product model has one DoC. A manufacturer may cover several models in a single declaration when the same legislation and standards apply to all of them, but every model covered has to be identifiable from the document. Great Britain has a parallel UK Declaration of Conformity behind UKCA marking, and other markets have their own forms of supplier’s declaration; the general shape of such a declaration is standardised in ISO/IEC 17050-1.

EC vs EU Declaration of Conformity: is there a difference?

No. They are the same document, and the name simply follows the legislation it is issued under. Directives written before the Lisbon Treaty took effect in 2009 refer to the European Community and ask for an “EC declaration of conformity”; the Machinery Directive 2006/42/EC is the best-known example, and the model declaration in Decision 768/2008/EC still carries the EC title. Legislation adopted since, including the 2014 alignment package (the Low Voltage, EMC, Radio Equipment and similar directives), uses “EU declaration of conformity”. Use the wording of the act you are declaring against, and expect to see older EC declarations still in circulation for products covered by older directives.

How the DoC relates to CE marking

CE marking and the Declaration of Conformity are two halves of one obligation. Before affixing the CE mark, the manufacturer must determine which directives and regulations apply, meet their essential requirements (usually by applying harmonised standards), carry out the conformity assessment procedure those acts prescribe, compile the technical documentation, and then draw up and sign the DoC. Only then is the mark affixed. A product placed on the EU market generally must have its DoC available on request, and some legislation requires a copy to accompany the product.

This is why “CE certification” is a misleading phrase. For most products the assessment is carried out by the manufacturer alone and the DoC is the only conformity document that exists. A notified body, an independent organisation designated by a member state, is involved only where the applicable legislation requires third-party assessment for that product category, and even then it is the manufacturer, not the notified body, who signs the DoC.

How do you get a Declaration of Conformity?

It depends on which side of the transaction you are on. If you are the manufacturer, you do not obtain a DoC from anyone: you write it. The steps are the CE marking process itself:

• Identify every directive and regulation that applies to the product and the market it is sold in
• Find the harmonised standards (or other technical specifications) that give a presumption of conformity with their essential requirements
• Carry out the conformity assessment procedure the legislation prescribes: internal production control for most products, a notified body where required
• Compile the technical documentation that proves conformity, including test reports and risk assessments
• Draw up the DoC using the elements below, sign it, and translate it into the languages required by the member states where the product is made available
• Affix the CE mark, keep the DoC and technical file for the required period (typically ten years), and re-issue the DoC when anything it relies on changes

If you are buying, importing or distributing a product, ask the manufacturer or its authorised representative for the DoC; a compliant manufacturer will have one and can supply it. Importers must check that the manufacturer has drawn up the DoC before placing a product on the EU market, and keep a copy available for the authorities. Distributors must verify that the product carries the CE mark and is accompanied by the documents the legislation requires. If a supplier cannot produce a DoC for a CE-marked product, treat that as a compliance red flag rather than a paperwork gap.

What an EU Declaration of Conformity must contain

The model structure for an EU Declaration of Conformity is set out in the EU’s common framework for product legislation (Decision 768/2008/EC, Annex III). A compliant DoC identifies the product, the responsible manufacturer, the legislation applied, and the standards used to demonstrate conformity.

Sector legislation can add elements to this model. The Radio Equipment Directive, for example, asks for the accessories and software that allow the equipment to operate as intended, and the Machinery Directive asks for the person authorised to compile the technical file. Check the annex of each act you cite before you treat the declaration as complete.

Declaration of Conformity vs Certificate of Conformance

The names are close and the documents are often confused, but they operate at different levels. A Declaration of Conformity is typically a product-level, regulatory statement against legislation and standards, tied to CE marking. A Certificate of Conformance is usually a shipment- or lot-level supplier statement against a purchase order or specification. One is about meeting the law to place a product on the market; the other is about assuring a customer that what shipped meets what was ordered. We cover the distinction in depth in Declaration of Conformity vs Certificate of Conformance.

Producing a DoC you can stand behind

A DoC is a controlled, signed document that must stay aligned with the technical file behind it. When a standard is superseded or a product variant is added, the declaration has to be updated and re-issued, which makes a fixed, version-controlled template far safer than a copied file. DataSheets Pro provides a free Declaration of Conformity template that follows the Annex III elements; identifying the correct legislation and standards, and confirming that the declaration is complete and current, remains your responsibility as the manufacturer.