EU Declaration of Conformity: Signing, Technical File, and Penalties

An EU Declaration of Conformity is a signed legal document in which the manufacturer states, under sole responsibility, that a product meets every applicable EU health, safety, and environmental requirement. It is the final step before affixing the CE mark and placing the product on the European Economic Area market, and EU market surveillance authorities can demand it, along with the supporting technical file, at any time.

Does Your Product Need One

The declaration is required only for products covered by EU harmonisation legislation that calls for CE marking. If no such legislation applies to your product, you cannot use the CE mark and do not need a declaration.¹ More than 25 directives and regulations currently mandate CE marking, spanning toys, radio equipment, machinery, personal protective equipment, medical devices, pressure vessels, construction products, gas appliances, lifts, and measuring instruments.²

A product often falls under more than one directive. A smart toy with a Bluetooth radio triggers both the Toy Safety Directive and the Radio Equipment Directive. When that happens, you issue one declaration listing every applicable directive, not a separate document per rule. The declaration covers the finished product as a whole, including any components or sub-assemblies you source from other suppliers, even where those suppliers already carry their own CE marks.³

Who Signs and Who Is Legally Responsible

The manufacturer creates, signs, and stands behind the declaration. EU law treats you as the manufacturer if you make the product yourself or have it made and sell it under your own name or brand, and that responsibility extends to every part of the product, including components supplied by others.¹

A manufacturer based outside the EU can appoint an authorized representative inside the EU to hold copies of the declaration and technical file and to deal with authorities. The representative acts under a written mandate, but the underlying compliance obligation stays with the manufacturer. Importers carry their own exposure: before placing a product on the EU market, they must verify that the manufacturer has drawn up the declaration and technical file, that the CE mark is affixed, and that labeling is correct. An importer with reason to believe a product does not comply cannot place it on the market and must notify the manufacturer and authorities.

The EU-Based Responsible Person

Regulation 2019/1020 added a rule that catches sellers who used to slip through. A product subject to EU harmonisation legislation can only be placed on the market if an economic operator established in the EU is responsible for specific compliance tasks. That person must be one of: a manufacturer established in the EU, an importer, an authorized representative with a written mandate, or, as a last resort, an EU-established fulfilment service provider handling the products.⁴

The responsible person’s name, trade name or trademark, and contact address must appear on the product, its packaging, or an accompanying document, in a language consumers and authorities can understand.⁴ Major online marketplaces now require sellers to submit responsible person details before listings go live, and products arriving at EU customs without this information can be held at the border.

Assessing Conformity Before You Sign

You cannot sign until you have actually assessed whether the product meets the essential requirements of every directive that applies. EU law offers a menu of conformity assessment procedures, labeled Module A through Module H, ranging from self-certification to full third-party involvement. The directive governing your product tells you which modules are available.

Self-Certification Under Module A

Module A, internal production control, is the simplest route. You assess the product yourself, build the technical documentation, and sign the declaration without involving an outside body.⁵ Module A is typically available for lower-risk products: many consumer electronics under the Low Voltage Directive, most products under the Electromagnetic Compatibility Directive, and simple machinery. You still have to perform every check a notified body would have performed, and you carry the full consequences if authorities later find the product non-compliant.

Third-Party Assessment

Higher-risk products require a notified body, an independent organization designated by an EU member state and listed in the European Commission’s NANDO database. Module B involves a notified body examining the technical design and issuing a type-examination certificate. Modules D, E, and F build on that certificate through production-phase oversight such as quality system audits or individual product verification.⁵ Medical devices, certain pressure equipment, and marine equipment typically require notified body involvement. The applicable directive always specifies which modules apply, so identifying every directive your product falls under is the first practical step.

Harmonised Standards

Harmonised standards are European standards (EN numbers) developed at the Commission’s request and cited in the Official Journal. Following a harmonised standard creates a legal presumption that you meet the essential requirements it covers. Their use is voluntary. You can demonstrate compliance through your own technical specifications, national standards, or international standards, but you lose the presumption of conformity, and your technical file then needs significantly more detail — including a full risk assessment and gap analysis — to show your alternative approach meets the essential requirements.⁶

What the Declaration Must Contain

Decision 768/2008/EC provides a model structure that individual directives adapt for their product categories. The core elements are consistent across almost all directives:⁷

Unique product identification — a serial, model, batch, or type designation that allows traceability. An image of the product may be included to help customs officers distinguish it from similar models.
The full legal name and registered business address of the manufacturer, or of the authorized representative where applicable.
A statement that the declaration is issued under the manufacturer’s sole responsibility.
A product description detailed enough to identify exactly what the declaration covers.
Every EU directive or regulation the product must comply with, referenced by official title and number (for example, the Radio Equipment Directive 2014/53/EU).
The reference numbers of the harmonised standards or other technical specifications applied.
Notified body details where relevant: name, identification number, description of what the body did, and the certificate reference.
The signature, printed name, function, place, and date, from a person authorized to bind the company.

The declaration must be kept current. If the applicable legislation or harmonised standards change, or if the product design is modified, the declaration has to be revised to reflect current reality.³

Signing, Electronic Signatures, and Language

The signature must come from someone with authority to legally commit the company, typically a managing director, compliance officer, or other senior executive. The signer’s name and function appear alongside the date and place of signing.⁷

Wet-ink signatures work, and so do electronic signatures. Under the eIDAS Regulation (910/2014), a qualified electronic signature carries the same legal standing as a handwritten signature, with advanced and qualified signatures requiring a digital certificate from a recognized Trust Service Provider.⁸

The declaration must be translated into the official language required by each member state where the product is sold, and language rules are set nationally rather than at EU level.⁷ Germany requires German for the declaration itself but accepts English for the broader technical documentation. The Netherlands accepts either Dutch or English for both. France requires French. Selling across all 27 member states means planning for multiple translations.

The Technical File Behind the Declaration

The declaration is one page; the technical file is where the evidence lives. At a minimum, it includes design and manufacturing information, a list of the harmonised standards or other specifications applied, test reports or calculations proving compliance, and a risk assessment.⁹ Some directives require more. The Medical Device Regulation, for instance, demands a benefit-risk analysis, clinical evaluation data, and full manufacturing site identification.

You must keep the technical file and the declaration available for market surveillance authorities for 10 years after the last unit of that product is placed on the market.⁹ Some sector-specific legislation sets a different retention period, so check the directive that applies to your product. When a border inspector or market surveillance officer sends a request, days of delay while someone hunts through filing cabinets can escalate into a formal investigation.

When Product Changes Trigger a New Declaration

Cosmetic changes to packaging or minor color variations generally do not require a new conformity assessment. A substantial modification to the product’s design, components, or materials that could affect compliance with the essential requirements does: you must run a fresh conformity assessment and issue a new declaration before placing the modified product on the market.³

Changes in the legal environment can trigger an update too. If the Commission publishes a new version of a harmonised standard and withdraws the reference to the old one, a product still relying on the old standard loses its presumption of conformity.

New Declaration Obligations Coming in 2026 and 2027

Two pieces of legislation are adding to what future declarations must cover for products with digital elements.

The Cyber Resilience Act entered into force in December 2024, with main obligations applying from 11 December 2027. Reporting obligations for actively exploited vulnerabilities begin on 11 September 2026.¹⁰ The first standardisation deliverables, including horizontal and product-specific cybersecurity standards, are expected in the third quarter of 2026.¹¹ If you make software-enabled hardware, standalone software, or connected devices, cybersecurity essential requirements will need to sit inside your design process well before 2027.

The AI Act becomes fully applicable on 2 August 2026, with an extended transition until August 2027 for rules on high-risk AI systems embedded in already-regulated products.¹² High-risk AI systems must undergo conformity assessment covering risk management, data quality, logging and traceability, transparency, human oversight, and cybersecurity, and the declaration will need to reflect compliance across all of these areas.

Penalties and Enforcement

Enforcement sits with national market surveillance authorities, and penalties vary sharply. Germany caps CE marking fines at around €3,000 for the marking violation itself, while Slovakia allows fines up to approximately €167,000. The Netherlands treats incorrect marking as a criminal offense under its penal code, punishable by up to two years imprisonment or a fine of up to €74,000. Ireland’s sectoral legislation allows fines up to €20,000 for explosives-related violations.¹³

Fines are only part of the exposure. Market surveillance authorities in every member state can withdraw products from the market, order recalls, and restrict or ban future sales. Customs can suspend release for free circulation of products lacking a responsible person on their labeling while authorities investigate. For online sellers, marketplaces can suppress listings within days of detecting missing compliance documentation. The commercial damage from a border hold or forced recall usually dwarfs the fine.

1
Your Europe. CE Marking
2
Government of the Netherlands. What Products Must Have CE Marking
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Your Europe. Signing a Declaration of Conformity
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EUR-Lex. Regulation (EU) 2019/1020 of the European Parliament and of the Council
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European Commission. Introduction to Conformity Assessment and CE Marking
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Your Europe. Conformity Assessment – Ensure Your Products Comply With EU Rules
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EUR-Lex. Decision 768/2008/EC of the European Parliament and of the Council
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European Commission. eSignature – Get Started
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Your Europe. Preparing Technical Documentation
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European Commission. Cyber Resilience Act
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European Commission. Cyber Resilience Act – Implementation
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European Commission. AI Act
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European Commission. Overview of Penalties for CE Marking Infringements