Documents & incidents
EU Declaration of Conformity (DoC): Which Products Need One, What It Must Contain, Template
Short answer
The EU declaration of conformity (DoC) is a document required by CE product laws: the manufacturer, or its authorised representative in the EU, declares that the product meets the listed EU legislation and takes responsibility for it. The Low Voltage, EMC, Radio Equipment, RoHS, Toy, Machinery, PPE and Batteries rules all require a DoC, written to the model in Annex III of Decision 768/2008/EC or the sector law's own annex. A product covered only by the GPSR has no DoC and must not carry the CE marking.
Key points
- A DoC is the manufacturer's own declaration under CE law: not a test report and not a certificate from a lab.
- Where several laws requiring a DoC apply, draw up one single DoC listing all of them (e.g. LVD Article 15(3)).
- Mandatory content: product number, manufacturer or representative name and address, the sole-responsibility statement, product identification, legislation, standards with editions, notified body if any, place, date and signature.
- The DoC must be translated into the language(s) required by the member state of sale; it is signed by the manufacturer or its authorised representative.
- Radio equipment, machinery and PPE must ship with the DoC or a link to it; for LVD, EMC and toys it is provided on request.
- Keep the DoC with the technical file, generally for 10 years; importers and the EU Responsible Person must check it exists and keep a copy.
What a DoC is: the manufacturer's declaration under CE law
The EU declaration of conformity comes from the EU's New Legislative Framework. Reference Article R10 in Annex I of Decision 768/2008/EC says the DoC states that fulfilment of the requirements has been demonstrated, follows the model structure in Annex III of that Decision, and is kept up to date; and that by drawing it up the manufacturer assumes responsibility for compliance. Each sector law copies these rules into its own text, for example Article 15 of the Low Voltage Directive 2014/35/EU, Article 15 of the EMC Directive 2014/30/EU and Article 18 of the Radio Equipment Directive 2014/53/EU.
The order matters: the manufacturer prepares the technical documentation and completes the conformity assessment procedure set by the law, and only then draws up the DoC and affixes the CE marking. Section 4.4 of the Commission's Blue Guide (2022) explains that the manufacturer or its authorised representative in the EU draws up and signs the DoC, which states that the product meets all relevant requirements.
The GPSR itself has no DoC. Products covered only by the GPSR, such as clothing, furniture or ordinary homeware, show safety through a risk analysis and technical documentation (see GPSR technical documentation). The CE marking may be affixed only where a law provides for it (Article 30(2) of Regulation (EC) No 765/2008), so a “CE DoC” and CE mark on a GPSR-only product are wrong.
Which products need a DoC
| Law | Typical products | DoC article / model | Must accompany product? |
|---|---|---|---|
| Low Voltage Directive 2014/35/EU | Electrical equipment 50–1,000 V AC or 75–1,500 V DC | Art. 15, Annex IV | No, on request |
| EMC Directive 2014/30/EU | Almost all electrical and electronic products | Art. 15, Annex IV | No, on request |
| Radio Equipment Directive 2014/53/EU | Bluetooth, Wi-Fi, remote-controlled products | Art. 18, Annex VI; simplified DoC Annex VII | Yes: full copy or simplified DoC with web address (Art. 10(9)) |
| RoHS Directive 2011/65/EU | Electrical and electronic equipment | Art. 13 | No, on request |
| Toy Safety Directive 2009/48/EC | Products for play by children under 14 | Art. 15, Annex III (“EC declaration of conformity”) | No, on request |
| Machinery Regulation (EU) 2023/1230 (applies from 14 January 2027; Directive 2006/42/EC until then) | Power tools, some garden equipment | Art. 21, Annex V Part A | Yes: DoC, or its web address or machine-readable code in the instructions (Art. 10(8)) |
| PPE Regulation (EU) 2016/425 | Safety glasses, helmets, protective gloves | Art. 15 | Yes: DoC or web address in the information (Art. 8(8)) |
| Batteries Regulation (EU) 2023/1542 | Batteries | Art. 18, Annex IX, electronic format | Check the regulation's specific rules |
Construction products use a “declaration of performance” instead. “On request” means the law does not require the DoC in the box, but you must supply it to authorities when asked, and marketplaces may ask for it too. From 1 August 2030, the digital product passport under Article 19 of the Toy Safety Regulation (EU) 2025/2509 replaces the toy DoC (see toys and GPSR). Electronics usually fall under several laws at once (see electronics and GPSR).
Mandatory content: the eight Annex III items
The model in Annex III of Decision 768/2008/EC (sector annexes are nearly identical, some with extras), with notes from Blue Guide section 4.4:
| Item | Content | Tips |
|---|---|---|
| 1 | Number (unique identification of the product) | Product, batch, type or serial number, as the manufacturer decides; numbering the DoC itself is optional |
| 2 | Name and address of the manufacturer or authorised representative | Same as on the product label |
| 3 | “This declaration of conformity is issued under the sole responsibility of the manufacturer” | Fixed wording; never “of the laboratory” |
| 4 | Object of the declaration (identification allowing traceability) | Brand, product name, model, optionally a picture; the Toy Safety Directive requires a colour image |
| 5 | Union harmonisation legislation the object conforms to | Full title and number of every applicable law |
| 6 | Harmonised standards or other specifications used | Numbers with edition or date; the Machinery Regulation also wants the OJ publication date and the parts applied if only partly applied |
| 7 | Notified body, where applicable | Name, number, what it did, certificate number; for self-declaration procedures (e.g. Module A) leave out or write “not applicable” |
| 8 | Additional information | E.g. grade or category; radio equipment adds accessories and software |
| — | Signature block | Signed for and on behalf of, place and date, name, function, signature |
The Blue Guide adds: with several laws, the single DoC may be a dossier of the individual declarations; the DoC may be a document, a label or equivalent, but all products it covers must be traceable to it; and once any element changes (legislation, standard edition, manufacturer or representative address), products placed on the market afterwards need an updated version.
Example template: Bluetooth speaker (fictional)
Brand, model, company and address are fictional, and the standards are deliberately left blank: fill them from your test reports and the applicable harmonised standards. Radio equipment follows the structure of RED Annex VI:
| Field | Example |
|---|---|
| Title | EU Declaration of Conformity No. DOC-BT100-02 |
| 1. Radio equipment (product, type, batch or serial number) | Bluetooth speaker, model BT-100 |
| 2. Manufacturer name and address | Example Audio Co., Ltd., [full postal address], China |
| 3. Statement | This declaration of conformity is issued under the sole responsibility of the manufacturer. |
| 4. Object of the declaration | Portable Bluetooth speaker BT-100, firmware V1.2, colour photo attached |
| 5. Legislation | Directive 2014/53/EU; Directive 2011/65/EU |
| 6. Standards | [EN number:edition year] for each safety, EMC, radio and health standard applied |
| 7. Notified body | Not applicable (if EU-type examination was used: name, number, certificate) |
| 8. Accessories and software | USB-C charging cable; firmware V1.2 |
| 9. Additional information | — |
| Signature | Signed for and on behalf of Example Audio Co., Ltd.; Shenzhen, 2026-10-15; Zhang San, General Manager; [signature] |
If the product contains a battery, check the Batteries Regulation (EU) 2023/1542 separately for its own DoC and labelling rules.
Who signs, which language, how long to keep it
- Signatory: the manufacturer or its authorised representative (Blue Guide 4.4). If you sell under your own brand, you are the manufacturer and the DoC should name your company, not the factory. The factory may help draft it, but a DoC in the factory's name will not match your label.
- Language: every sector law requires translation into the language(s) required by the member state of sale, e.g. LVD Article 15(2), RED Article 18(2), Toy Safety Directive Article 15(2). Laws do not always say who translates; the Blue Guide says that if another operator translates and the manufacturer does not sign the translation, a copy of the signed original must be provided with it.
- Retention: the manufacturer keeps the DoC and technical file for 10 years (e.g. LVD Article 6(3); at least 10 years under the Machinery Regulation); the importer keeps a copy for 10 years (e.g. LVD Article 8(8)).
- EU Responsible Person: Article 4(3)(a) of Regulation (EU) 2019/1020 requires the EU-based operator to verify that the DoC has been drawn up and keep it available for the required period, so your representative will ask for a copy (see who is the EU Responsible Person).
- Stamp: the models ask for name, function and signature; no company stamp is required.
The Commission's May 2025 simplification proposals COM(2025) 503 and 504 include an electronic DoC. They are still proposals; see GPSR timeline and updates.
DoC vs test report, certificate and technical file
| Document | Issued by | Role |
|---|---|---|
| EU DoC | Manufacturer or authorised representative | Declares conformity with the listed laws and takes responsibility |
| Test report | Laboratory | Results for a sample; evidence in the technical file |
| Voluntary “CE certificate” | Lab or certification body | Commercial document; cannot replace the DoC |
| EU-type examination certificate | Notified body | Only where the law requires a notified body; cited in DoC item 7 |
| Technical documentation | Manufacturer | All evidence of conformity; the basis for the DoC |
When a marketplace or customer asks for a “CE certificate”, they usually mean the DoC plus test reports. For reading reports, see GPSR testing, standards and presumption of conformity.
DoC checklist
- List the CE laws that apply and require a DoC; for GPSR-only products, no DoC and no CE mark.
- Finish the technical file and the required conformity assessment before drawing up the DoC.
- Fill in every item of the model in the applicable annex and list all laws.
- Give standards with edition years and identify parts applied where only partly applied.
- Sign in the name of the brand owner (manufacturer) or authorised representative, with place, date, name and function.
- Prepare language versions for each country of sale and keep the signed original.
- For radio equipment, machinery and PPE, prepare the copy, simplified DoC or web address that must accompany the product.
- Send copies to your importer and EU Responsible Person, keep for 10 years, and update when laws or standards change.
Common mistakes
Issuing a DoC and CE mark for a GPSR-only product
The CE marking may only be affixed where a law provides for it (Article 30(2) of Regulation (EC) No 765/2008). Clothing, furniture and other GPSR-only products need a risk analysis and technical documentation, not a CE DoC.
Treating a lab's “CE certificate” as the DoC
A lab certificate or report is not a DoC. The DoC must be signed by the manufacturer or its authorised representative, and the manufacturer takes responsibility. Even with a report in hand, you still draw up and sign the DoC yourself using the model.
Missing laws and standards without editions
A Bluetooth product usually falls under both RED and RoHS, so one single DoC must list both. Standards without an edition year leave it unclear which version you used, and a revised standard means an updated DoC.
Frequently asked questions
Do GPSR-only products need a declaration of conformity?
No. The GPSR has no DoC; these products rely on a risk analysis and technical documentation, and must not carry the CE marking. If a marketplace asks for a “declaration of conformity”, first check whether a CE law really applies to the product.
Can the factory sign the DoC?
The DoC is signed by the manufacturer or its authorised representative. If you sell under your brand, you are the manufacturer in law and the DoC should be issued in your company's name. The factory can supply data and help draft it, but a DoC in the factory's name will not match your label.
Does the DoC need translating for every country?
Each sector law requires translation into the language(s) required by the member state of sale (e.g. LVD Article 15(2)). Requirements differ by country; a common approach is a signed English original plus translations for each country of sale, supplied together.
Does a DoC need a company stamp, and does it expire?
The models require “signed for and on behalf of”, place and date, name, function and signature; no stamp. A DoC does not expire but must be kept up to date: after a change in legislation, standard editions or manufacturer details, products placed on the market afterwards need the new version.
Can one DoC cover several models?
The Blue Guide requires enough information for every product covered to be traced to the DoC, so a clearly listed range can share one; the Machinery Regulation asks for one per model. Models under different laws or standards need separate declarations.
Official sources
- Decision No 768/2008/EC on a common framework for the marketing of products, Article R10 and Annex III (EUR-Lex)
- The 'Blue Guide' on the implementation of EU product rules 2022, section 4.4 (EUR-Lex)
- Directive 2014/35/EU (Low Voltage Directive), Article 15 and Annex IV (EUR-Lex)
- Directive 2014/30/EU (EMC Directive), Article 15 and Annex IV (EUR-Lex)
- Directive 2014/53/EU (Radio Equipment Directive), Articles 10(9) and 18, Annexes VI and VII (EUR-Lex)
- Directive 2009/48/EC on the safety of toys, Article 15 and Annex III (EUR-Lex)
- Regulation (EU) 2023/1230 on machinery, Articles 10(8) and 21, Annex V (EUR-Lex)
- Regulation (EC) No 765/2008, Article 30 (CE marking) (EUR-Lex)
- Regulation (EU) 2019/1020 on market surveillance, Article 4 (EUR-Lex)
This guide explains Regulation (EU) 2023/988 in plain language. It is general information, not legal advice. Requirements can depend on your product, other EU laws and the member state — check the official text and, for your own case, a qualified adviser.