Service

Declaration of conformity

The declaration of conformity is the document in which the manufacturer or importer confirms, under their sole responsibility, that the product meets the requirements of the EU legislation applicable to it. Without it the product may not be placed on the market — and without the technical file it is based on, it is just a sheet of paper. We prepare both.

Connector with a wiring harness on a wiring diagram

Responsibility

Who issues and signs the declaration

Always the manufacturer, or whoever takes on their obligations — an importer placing a product from a third country on the EU market, or an authorised representative.

It is not a document a consultant or a test laboratory issues on your behalf: the signature and the responsibility stay with you. Our role is to prepare the supporting documents and the wording so that the signature has something to rest on.

RetentionAs a rule ten years from placing the product on the market. The surveillance authority may ask for the documentation at any point during that period.
Product changesA modification that affects conformity means a new assessment and a new declaration.

Required content

What the declaration must contain

Each piece of legislation sets out the exact list in its own annex, but the skeleton is the same across all of them:

  1. The declaration number and identification of the product — type, batch or serial number.
  2. The name and address of the manufacturer, or of the authorised representative.
  3. A statement that the declaration is issued under the sole responsibility of the manufacturer.
  4. The object of the declaration, described so the product is traceable — for some legislation including a colour image.
  5. References to the relevant EU harmonisation legislation the product complies with.
  6. References to the harmonised standards applied, including their date of issue.
  7. Where a notified body is involved, its name, identification number and the certificate issued.
  8. Place and date of issue, name, function and signature.

From practice

The mistakes we run into most often

The declaration exists, the technical file does not. The document then has nothing to rest on, and an inspection reveals it with the first question.
A standard referenced without its date of issue, or a standard that has since been superseded.
Directives listed that do not apply to the product. It looks like caution; in fact it shows the product was never assessed.
A declaration taken over from a supplier outside the EU, while the manufacturer's obligations rest with the importer.
The product changed, the declaration did not. A change affecting conformity means a new assessment.
Signed by someone without authority — the declaration is signed by a person authorised to act for the company.
Cardboard packaging ready for dispatch in a warehouse

New from 12 August 2026

Packaging needs its own declaration of conformity

The Packaging and Packaging Waste Regulation (EU) 2025/40 — PPWR for short — applies to packaging the same logic you know from products: technical documentation, conformity assessment, marking and a separate declaration of conformity for the packaging.

This also affects companies that manufacture nothing themselves and only pack and sell goods. The declaration for the product does not cover the packaging.

How it works

Four steps from product description to signature

  1. 01

    Consultation

    Product description, photos, schematic. We tell you what applies and what is missing.

  2. 02

    Legislation and standards

    Directives, harmonised standards, conformity assessment module.

  3. 03

    Documents

    Risk assessment, testing, technical file.

  4. 04

    Declaration

    A document ready for signature and a file ready to present.

Frequently asked

The questions we hear most

Can I issue the declaration myself?

Yes. It is issued by the manufacturer or the importer under their sole responsibility and no one else is needed for it. The question is not whether you may, but whether you have the technical file the document rests on.

Do I need a certificate from a test laboratory?

For most products, no. A notified body only comes into play where the legislation explicitly requires it — typically for selected categories of machinery, pressure equipment or higher-class medical devices.

How long does it take and what does it cost?

We will give you both once we have a description of the product. They depend on how many pieces of legislation apply, whether testing is needed and what you already have in place. We adapt lead times to the client's needs and the first consultation is free.

What if an inspection has already taken place?

Get in touch immediately. We review what exists for the product, supply the missing documents and prepare an expert statement for dealing with the inspectors. Details on the Inspection page.

Working on a specific product?

Write a few sentences about the device. We will come back with a proposed approach, a lead time and a price — the first consultation is free.