The EU Declaration of Conformity: A Complete Guide for Manufacturers

Last updated: October 19, 2026

An EU Declaration of Conformity (DoC) is the document where the manufacturer states, under its sole responsibility, that a product meets every EU law that applies to it. You need one before you place any CE marked product on the EU market.

It’s also one of the most misunderstood documents in the CE marking process. Manufacturers outside the EU frequently confuse it with a certificate, delegate it to the wrong person, or produce it without the required content.

What Is the EU Declaration of Conformity?

The EU Declaration of Conformity is a legally binding declaration, prepared and signed by the manufacturer before the product is placed on the EU market. You’ll also see it called the EC Declaration of Conformity, the older name that the Machinery Directive 2006/42/EC still uses until January 20, 2027. Some people call it a declaration of conformance or a declaration of compliance. They all refer to the same document.

The DoC is specific to CE marking legislation. It signals to market surveillance authorities, distributors, and buyers that

the conformity assessment has been completed, the technical documentation has been prepared, and the product meets the essential requirements of the applicable directives or regulations.

Who Is Required to Issue a DoC?

The manufacturer is always the legal entity responsible for issuing the DoC, regardless of where the manufacturer is established. A company based in the United States, Australia, or Japan that places a product on the EU market must issue the DoC under its own name and address.

If the manufacturer has appointed an EU Authorised Representative, the representative’s name and address can also appear in the DoC. This is optional, and it doesn’t shift any legal responsibility. The declaration remains the manufacturer’s.

Separately, Regulation (EU) 2019/1020 requires an EU-based economic operator for many CE marked products. That operator’s details go on the product, its packaging, or an accompanying document, not in the DoC.

Importers and distributors do not issue DoCs.

Their obligations under EU market surveillance legislation are different, and the DoC always originates from the manufacturer.

When Is a DoC Required?

A DoC is required for every product subject to CE marking legislation before it is placed on the EU market. This covers the vast majority of regulated product categories: machinery, electrical equipment, radio equipment, toys, personal protective equipment, pressure equipment, and many others.

Two distinctions are relevant for non-EU manufacturers.

The General Product Safety Regulation (EU) 2023/988 does not require a DoC. Products subject only to the GPSR must have technical safety documentation and comply with labelling and responsible person requirements, but the DoC as a specific document is a CE marking concept.

Some manufacturers prepare a voluntary DoC-style document for GPSR-only products to simplify customs clearance in certain EU member states. There is no legal prohibition on this, provided the document does not falsely imply CE marking obligations and clearly identifies itself as a voluntary safety declaration under the GPSR.

Products without CE marking obligations still carry significant GPSR compliance requirements that manufacturers should not overlook.

Construction products under the Construction Products Regulation use an EU Declaration of Performance (DoP), not a DoC. These are different documents with different structures and different purposes.

Is a DoC Always Self-Declared? What Happens When a Notified Body Is Involved?

For most products and most directives, the manufacturer conducts the conformity assessment independently and self-declares conformity. The DoC reflects this: the manufacturer states that the product meets the applicable requirements, references the standards applied, and signs the document.

Some product categories require mandatory involvement of a notified body before the DoC can be issued. This applies when the product falls within a high-risk category listed in the applicable directive, when no harmonised standard covers the product, or when the standards have only been partially applied. In these cases, the conformity assessment includes a third-party evaluation such as EU type-examination or full quality assurance.

When a notified body is involved, the DoC must reference the notified body’s certificate number and the body’s four-digit identification number. The CE mark affixed to the product must also include that identification number. The DoC is still issued by the manufacturer, but only after the notified body has completed its assessment and issued the relevant certificate.

The step-by-step process for determining whether a notified body is required, and what follows, is covered in the article on the CE marking certification process.

What Must a DoC Contain?

The mandatory content of a DoC is set out in each applicable directive or regulation, based on the model in Annex III of Decision 768/2008/EC. The required elements are consistent across most directives, with minor variations.

The DoC must be part of the broader technical documentation file, which includes design drawings, risk assessments, test reports, and all other evidence supporting the declaration.

EU Declaration of Conformity Example and Template

Here’s what a complete EU Declaration of Conformity looks like. It’s for a fictional IoT device, but the structure is the same one you’d use for a real product, with every field from the table above in the order the Radio Equipment Directive asks for.

One DoC or Several? How to Handle Multiple Directives

A product subject to multiple EU directives requires a single DoC that references all applicable directives simultaneously. Issuing separate DoCs, one per directive, is incorrect and creates inconsistencies in the documentation.

The standard structure lists each applicable directive in a dedicated section of the declaration, with the corresponding harmonised standards for each. The signatory declares conformity with all listed legislation in a single document.

This is one of the most common structural errors found in DoCs from non-EU manufacturers: a document that references only the most prominent directive while omitting others that also apply. A machine with wireless connectivity may be subject to the Machinery Directive 2006/42/EC (the Machinery Regulation (EU) 2023/1230 from January 20, 2027), the Radio Equipment Directive 2014/53/EU, and the RoHS Directive 2011/65/EU at the same time. All of them must appear in a single DoC.

Can One DoC Cover Multiple Products?

A single DoC can cover a range of products when those products form a defined product family: identical design, same manufacturing process, same applicable standards, and the same conformity assessment. The DoC must clearly identify all products covered, typically by listing model numbers or type designations.

A DoC covering multiple products is appropriate for series production of identical units. It is not appropriate for products with different technical specifications, different applicable standards, or different intended uses, even if they share a brand name or product line designation.

Can I Use a Single DoC for Both CE and UKCA?

A single document covering both CE and UKCA marking is technically possible but generally inadvisable, and in most cases the administrative saving does not justify the risk.

CE marking and UKCA marking are declarations under different legal frameworks. CE marking is governed by EU legislation; UKCA marking is governed by UK domestic legislation. The applicable standards referenced in each declaration are national equivalents that, while often identical in technical content, carry separate references. A combined document must list EU directives and harmonised EN standards for CE, and UK regulations and BS EN standards for UKCA, in clearly separated sections.

The practical problem is maintenance. When either the EU or UK framework changes, a combined document requires updating across both sections simultaneously. A documentation error in one section can affect the validity of both declarations. For products with long market lifespans or frequent design updates, two separate documents are considerably easier to manage and audit.

What Language Must the DoC Be In?

The DoC must be made available in the official language or languages of each EU member state where the product is placed on the market. A product sold in France, Germany, and Poland requires the DoC to be available in French, German, and Polish.

The manufacturer may maintain a master DoC in English and provide translations for each market. All translations must be accurate and complete; condensed or simplified translations do not satisfy the requirement. For manufacturers distributing across multiple EU markets, preparing all required language versions at the time of initial market entry avoids delays later.

How Long Must the DoC Be Kept?

The DoC must be retained for a minimum of ten years from the date the last unit of the product was placed on the EU market. This retention period applies to the DoC itself and to the complete technical documentation file that supports it.

This obligation falls on both the manufacturer and the importer.

The manufacturer must keep the full technical documentation. The importer must keep a copy of the DoC and make it available to market surveillance authorities upon request, typically within a few working days. For non-EU manufacturers selling through EU importers, ensuring that the importer holds a current copy of the DoC is part of the compliance arrangement and should be addressed explicitly in the commercial agreement.

The ten-year obligation runs from the last unit placed on the market, not from the date of manufacture or the date the DoC was signed. For products with long production runs, this extends the retention obligation considerably beyond the initial CE marking date.

What Happens When the Product Changes?

A DoC is valid for the product as it was assessed at the time of issue. When the product changes, the manufacturer must evaluate whether the change constitutes a substantial modification: one that affects compliance with the applicable essential requirements or alters the risk profile of the product.

If the change is substantial, a new gap analysis must be conducted, and a new DoC must be issued. The previous DoC becomes invalid for the modified product.

Software and firmware updates require particular attention. An update that modifies the safety functions of a machine, changes the radio frequency behaviour of a wireless device, or affects the performance characteristics covered by harmonised standards may constitute a substantial modification even when the physical hardware remains unchanged. The manufacturer must assess each update against the criteria defined in the applicable directive.

Minor changes, such as cosmetic modifications or component substitutions that do not affect safety-relevant functions, typically do not require a new DoC. The assessment and its conclusion must be documented regardless.

Common Mistakes in EU Declarations of Conformity

Referencing superseded versions of harmonised standards. Standards are updated periodically. A DoC that references an EN standard whose harmonised reference has been withdrawn from the Official Journal no longer provides a presumption of conformity. The applicable version at the time of placing the product on the market must be referenced.

Omitting applicable directives. A product subject to multiple directives that references only one in the DoC is non-compliant. Market surveillance authorities check all applicable legislation, not just the most prominent one.

Signing before the conformity assessment is complete. The DoC must be dated after the conformity assessment has been finalised and the technical documentation has been completed. A DoC dated before testing was conducted, or before the technical file was assembled, is legally invalid.

Incorrect identification of the signatory. The DoC must be signed by a person authorised to do so on behalf of the manufacturer. An unsigned DoC or one signed by a person without the relevant authority does not satisfy the requirement.

Missing product identification. The DoC must identify the specific product it covers. A generic description that could apply to multiple unrelated products is not sufficient. Model numbers, type designations, or serial number ranges must be included.

Not updating the DoC after product changes. A DoC issued for the original version of a product does not automatically cover modified versions. Each substantial modification requires a new conformity assessment and a new DoC.

FAQ: Quick Answers to the Most Common Questions

Is the DoC the same as a CE certificate or a certificate of conformity? No. A certificate issued by a notified body, such as an EU type-examination certificate, covers specific aspects of the conformity assessment. The DoC is issued by the manufacturer and constitutes the formal declaration of conformity with all applicable legislation. Both may exist for the same product, but they serve different purposes. Some test labs also issue a “certificate of conformity” or “CE certificate” after testing. These are voluntary documents with no legal status under CE marking legislation, and they can’t replace the DoC.

Does the DoC need to be signed physically? EU legislation requires a signature but does not specify that it must be handwritten. A digital signature satisfying the requirements of Regulation (EU) No 910/2014 (eIDAS), as amended by Regulation (EU) 2024/1183, is acceptable. A physical signature on the master document remains the safest approach when dealing with authorities across different member states.

Who can sign the DoC if the manufacturer is not EU-based? The DoC must be signed by a person authorised to act on behalf of the manufacturer. This is a function of the manufacturer’s internal authority structure. A non-EU manufacturer can sign the DoC from their home country. If an EU Authorised Representative is listed in the document, it usually doesn’t sign it, unless the manufacturer’s written mandate allows it.

Do I need a new DoC if I change my supplier for a component? A component supplier change requires an assessment of whether the change affects compliance with applicable essential requirements. If the substitute component has the same specifications and does not affect safety-relevant functions, a new DoC is typically not required, but the assessment and its conclusion must be documented. If the substitute component affects compliance, a new conformity assessment and a new DoC are needed.

Is the DoC public or confidential? The DoC must be made available to market surveillance authorities on request and is often required to accompany the product or be accessible via a link or QR code. The technical documentation file that supports the DoC is a separate document and may be kept confidential, accessible only to authorities.

What is a simplified EU Declaration of Conformity? It’s a short version allowed under the Radio Equipment Directive (Article 10(9) and Annex VII). Instead of shipping the full DoC with each unit, the manufacturer can include one statement: that the radio equipment type complies with Directive 2014/53/EU, plus the exact web address where the full DoC is available. The full DoC still has to exist and be accessible at that address.

What is the difference between a DoC and a Declaration of Performance? A Declaration of Performance (DoP) applies to construction products under the Construction Products Regulation and declares the product’s performance against harmonised technical specifications. The DoC applies to products under CE marking directives and declares conformity with essential safety requirements. They serve analogous functions in different regulatory frameworks and are not interchangeable.

Can the DoC and the technical file be the same document? The DoC is a specific document with defined mandatory content. The technical file is a broader collection of documentation including design drawings, risk assessments, test reports, and other supporting evidence. The DoC is one element within the technical file, but the two are not the same document.

Does a DoC cover product liability? The DoC is a regulatory compliance document. Product liability in the event of harm to a person or property is governed by separate legislation, including the revised EU Product Liability Directive (EU) 2024/2853, which applies to products placed on the market from December 9, 2026. A valid DoC supports a defence in a product liability case but does not constitute one.

Can I download a DoC template? You can use the EU Declaration of Conformity example above as a starting point. Any template must be adapted to each specific product, each applicable directive, and each set of harmonised standards applied. A generic template used without proper adaptation is one of the most common sources of non-compliant declarations. The content, not the format, determines validity.

How GetReady Compliance Can Help

Preparing a legally valid DoC requires completing the conformity assessment, assembling the technical documentation, and accurately identifying all applicable legislation and standards. For non-EU manufacturers managing this process for the first time, or for products subject to multiple directives simultaneously, the risk of structural errors in the DoC is significant.

GetReady Compliance supports manufacturers through the full conformity assessment and documentation process, including DoC preparation, technical file structure, and review of existing declarations for compliance gaps.

Already have a DoC and not sure it’s right? Send it to us and we’ll check it against the applicable directives and standards. If you would like a product-specific assessment, request a quote or book a session through the CE Marking Online Advisor.

Read this far? The next step is a free 30-min consultation