Quick answer: what is each one?
If someone has asked you for a CE certificate to sell in Europe, there is something worth clarifying from the outset: that document, as most people understand it, does not exist. What do exist are the CE marking, the EU Declaration of Conformity and, in certain cases, a certificate issued by a notified body. These three concepts are frequently confused, but they serve different functions and carry very different legal consequences.
- The CE marking is the visible symbol placed on the product or its packaging.
- The EU Declaration of Conformity is the legal document signed by the manufacturer — or their representative — declaring that the product meets the applicable European legislation.
- A notified body certificate is an additional document that only appears for certain products or procedures, where the legislation specifically requires it.
None of them replaces the others. Confusing them can mean selling with insufficient documentation.
Who is this article for?
This article is useful if you are a manufacturer, importer or distributor of consumer products intending to sell in the EU, if you have been asked for a CE certificate and are not sure exactly what it is, or if you already have documentation but are unsure whether it is sufficient for an inspection or a customs check.
What is CE marking (and what it is not)
The CE marking is a regulated conformity marking. Placing it on a product indicates that the manufacturer declares that the product meets the essential requirements set out in the applicable European legislation — EU harmonisation directives or regulations.
It is not a quality symbol, a third-party certification or an absolute safety guarantee. It is a visual declaration by the manufacturer, backed by technical documentation that must exist and be retained.
Products such as toys, electrical equipment, machinery, personal protective equipment or medical devices, among many others, are subject to CE marking. But not all consumer products require it — it depends on whether they fall within the scope of an EU harmonisation directive or regulation.
What is the EU Declaration of Conformity
The EU Declaration of Conformity (DoC) is the central document in the conformity process for the European market. It is a formal document with legal value, in which the manufacturer — or, where the legislation permits, their EU authorised representative — declares that the product complies with all applicable harmonisation legislation.
This document is not issued by any laboratory or certification body by default. It is drafted and signed by the manufacturer themselves, or by whoever acts on their behalf. That signature implies assuming legal responsibility for the product's compliance.
The EU Declaration of Conformity is a prerequisite for legally placing the CE marking. Without it, the marking has no legal basis.
Who signs it and who bears legal responsibility?
The EU Declaration of Conformity is signed by the manufacturer or their EU authorised representative, if the applicable legislation allows for it. The authorised representative's signature does not transfer the underlying responsibility to the representative — the primary legal responsibility for product compliance rests with the manufacturer who places the product on the market under their name or brand.
If the manufacturer is outside the EU and has not appointed an authorised representative with a proper legal mandate, there may be no one who can legally sign the declaration in Europe. Depending on the applicable legislation, this can prevent the product from being placed on the market.
What a valid EU Declaration of Conformity must include
- Manufacturer identification (name, full address).
- Product description and identification (model, reference, serial number if applicable).
- Reference to the applicable EU harmonisation legislation (directives or regulations).
- Reference to harmonised standards or other technical documents used to demonstrate conformity, where applicable.
- Reference to the notified body and certificate number, if it has been involved in the process.
- Date and place of issue.
- Identified signature of the responsible person with name and position.
An incomplete or incorrect declaration can be grounds for rejection at customs or during a market surveillance inspection.
Not sure whether your product requires only a self-declaration or also the involvement of a notified body?
A prior review of the conformity route prevents documentary errors that block the sale. At Conformity Point we help manufacturers, importers and brands identify exactly what documentation they need.
Does a CE certificate actually exist?
There is no official document called a "CE certificate". It is an informal term widely used in trade, but one that has no legal recognition in European legislation. What do exist are different documents that are sometimes grouped under that name incorrectly — and that confusion can be costly.
When someone requests a "CE certificate", they usually mean one of three things — or a combination of all three:
- The EU Declaration of Conformity, which is the manufacturer's legal document and the only one that provides legal backing for the CE marking.
- A test report issued by an accredited independent laboratory, which provides technical evidence of compliance with certain requirements or standards, but is not a conformity document on its own.
- A certificate issued by a notified body, which only appears when the applicable legislation expressly requires it for certain products or assessment procedures.
Neither of the latter two replaces the EU Declaration of Conformity. They may form part of the technical file that underpins it, but without the declaration signed by the manufacturer, the CE marking has no legal basis — regardless of how many additional reports or certificates exist.
What documents you need before issuing the declaration and placing the CE marking
The EU Declaration of Conformity is not drafted at the start of the process, but at the end. Before signing it, the manufacturer must have completed the prior steps that justify it. These include, at a minimum:
- Identifying the applicable EU harmonisation legislation for the product.
- Determining the essential requirements the product must meet under that legislation.
- Assessing the product's conformity against those requirements (through testing, technical analysis or other valid methods).
- Compiling the technical file, which is the set of documents that supports the product's compliance and must be available to the authorities.
- Determining whether the legislation requires the involvement of a notified body and, if so, completing that process.
The technical file is the evidentiary foundation of everything. Without it, the EU Declaration of Conformity is a document without substance. If the authorities request it and it does not exist or is incomplete, the consequences can be serious.
Step by step: from product to correct documentation
Identify the applicable legislation: determine which EU harmonisation directives or regulations apply to the product based on its category, intended use and characteristics.
Analyse the essential requirements: review what technical, safety or performance conditions the legislation requires for the product.
Assess conformity: carry out or commission the testing, technical analysis or assessments needed to verify that the product meets those requirements. If the legislation requires a notified body, include that step.
Build the technical file: gather all supporting documentation — technical specifications, drawings, test results, risk analyses, instructions for use, labelling, etc.
Draft and sign the EU Declaration of Conformity: with all documentation in order, issue the declaration with all mandatory elements and sign it.
Place the CE marking: once the declaration is signed and the technical file is complete, the CE marking can be placed on the product in accordance with the applicable legislation.
Retain the documentation: keep the technical file available for the period required by the legislation (generally 10 years from the date the last product was placed on the market).
Common mistakes when requesting or using a supposed CE certificate
- Asking the supplier or manufacturer for a CE certificate as if it were a single document. There is no universal document with that name. What must exist is the EU Declaration of Conformity, backed by the technical file.
- Confusing test reports with declared conformity. A laboratory report is technical evidence. It is not the EU Declaration of Conformity and does not replace the technical file.
- Assuming that the notified body certificate is sufficient. The notified body certificate is one piece of the process, not the final document. The declaration is still signed by the manufacturer.
- Placing the CE marking without having the technical documentation in order. CE marking without a valid EU Declaration of Conformity and without a technical file is a regulatory infringement.
- Believing that once the documentation is obtained, it no longer needs to be reviewed. If the product, its intended use, the applicable legislation or the relevant technical standards change, the documentation must be updated.
Risks of selling with incorrect or incomplete documentation
Market surveillance in the EU is active and enforced. Market surveillance authorities in EU member states can request the EU Declaration of Conformity and the technical file at any time. Customs can also require this documentation to allow the product entry.
If the documentation does not exist, is incomplete or is incorrect, the consequences may include: detention of goods, withdrawal from the market, ban on sale, administrative fines and civil or criminal liability for the responsible operator.
In the context of the General Product Safety Regulation (GPSR), in force since December 2024, economic operators — manufacturers, importers, distributors and responsible persons — have documentary and traceability obligations that further reinforce the importance of having everything in order before placing products on the market.
Frequently asked questions
What to remember before selling in Europe
CE marking, EU Declaration of Conformity and CE certificate are not synonyms. Each has a specific function within the European conformity system, and confusing them can lead you to sell with documentation that does not carry the legal weight you think it does.
The declaration is signed by the manufacturer or their authorised representative, not a laboratory. The technical file exists before the declaration, not after. And the CE marking is the result of having everything in order — not the starting point.
If you are unsure what applies to your product, what documentation you need or whether what you already have is sufficient, the next step is to carry out a review before the problem surfaces at customs or during a market surveillance check.
Have questions about the documentation your product needs to sell in Europe?
At Conformity Point we help manufacturers, importers and brands prepare the correct documentation and sell with confidence in the European market.
conformitypoint.comThis article provides general information about the European regulatory framework. Each product may be subject to specific requirements. Always consult a specialist to assess your specific case.
Author
Written by Juan Manuel Beltrán, Founder & Product Compliance Consultant at Conformity Point. Specialist in consumer product compliance for the European market, helping manufacturers, importers and brands sell consumer products in Europe.
Last updated: March 2025