The Declaration of Conformity (DoC) — formally the EU Declaration of Conformity — is the legal document in which the manufacturer (or their EU-based authorised representative) declares, under their sole legal responsibility, that a product satisfies all the requirements of the applicable EU harmonisation legislation. Affixing the CE mark to a product without a valid DoC is a criminal offence under EU product safety law.
What the DoC Is Not
The DoC is frequently and mistakenly called a “CE certificate”. This is incorrect in two important ways:
- It is a self-declaration, not a certificate. For the vast majority of products and directives (EMC, LVD, most RED products, RoHS), the manufacturer drafts and signs the DoC themselves — no third-party certifier issues it. The manufacturer bears full legal liability for its accuracy.
- It is not issued by a Notified Body. Notified Bodies issue EU Type Examination Certificates or EU Type Approval certificates for specific high-risk directives (Machinery Category III, MDR Class IIa+). These are separate documents from the DoC; the DoC references them but is still signed by the manufacturer.
Mandatory Content
According to the New Legislative Framework (NLF), a DoC must contain:
| Field | Description |
|---|---|
| Product identification | Name, model, type or serial number, product batch (sufficient to identify the exact product) |
| Manufacturer name and address | Full legal name and registered address of the EU responsible entity |
| Sole responsibility statement | The declaration that it is issued under the manufacturer’s sole responsibility |
| Object of the declaration | Precise product identification that allows it to be traced |
| Directives and regulations covered | List of every EU directive and regulation the declaration covers |
| Harmonised standards applied | References to all EN standards used (with publication dates as listed in the OJEU) |
| Notified Body references | If applicable: name, number, and certificate reference |
| Signatory | Name, function, date and signature of the authorised person |
One DoC Can Cover Multiple Directives
A single DoC may declare conformity with multiple directives simultaneously — e.g., EMC Directive, Low Voltage Directive, and RED for a Wi-Fi product, or EMC and CRA for a wired connected device. However, once the CRA becomes fully mandatory (December 2027), CRA may require a separate or clearly identified section within the DoC due to its post-market obligations.
DoC Retention and Availability
The DoC must be:
- Kept for 10 years after the last unit is placed on the market (some directives specify 15 years)
- Provided to market surveillance authorities on request, within the timeframe specified (typically 10 days)
- Made available to end customers — for consumer products, often mandated to be physically included. For B2B products, it is typically available on request or downloadable from the manufacturer’s website
What Invalidates a DoC
A DoC becomes invalid and the CE mark becomes unlawful if:
- The product changes materially (new component, new software version with changed behaviour)
- A referenced harmonised standard is withdrawn and replaced in the OJEU and the manufacturer does not update compliance
- A relevant directive is repealed and replaced (e.g., Machinery Directive 2006/42/EC was replaced by Machinery Regulation EU 2023/1230 — existing DoCs under the old directive must be updated as of January 2027)
- A Notified Body certificate referenced in the DoC is suspended or withdrawn
Official References
- Regulation (EC) No 765/2008 — CE Marking and market surveillance framework — EUR-Lex (legal basis for the Declaration of Conformity requirement)
- Decision No 768/2008/EC — NLF, Annex III: EU Declaration of Conformity template — EUR-Lex (defines mandatory DoC content)