- All guides
- EU Declaration of Conformity (DoC): template and content
EU Declaration of Conformity (DoC): template and content
The EU Declaration of Conformity (DoC) is the document by which the manufacturer, or its authorised representative, states that fulfilment of the applicable requirements has been demonstrated; by drawing it up, the manufacturer "shall assume responsibility for the compliance of the product" (Decision 768/2008/EC, Article R10). Every CE act annexes its own model, and the models differ in small ways that matter when one declaration has to cover radio, RoHS and machinery at once. This page reads Annex III of the Decision, the models of RED, LVD, EMC, RoHS, ATEX, the Machinery Directive and Regulation, MDR and IVDR, and the Blue Guide 2022, as of 7 October 2026, with a template that cites the harmonised standards actually in force.
Key points
Section titled “Key points”- Eight points and a signature block. Annex III of Decision 768/2008/EC has eight numbered points, then "signed for and on behalf of", place and date, name, function and signature. Each act restates it with its own changes.
- The declaration number is optional. Point 1 identifies the product, and the Blue Guide says that number "does not need to be unique to each product".
- One product, one DoC. Where several acts require a declaration, a single DoC covers them all, with their publication references; it may be a dossier of individual declarations.
- Standards with their version. RED Annex VI requires "identification number and version"; the EMC model requires "the date of the standard". On 7 October 2026 a Wi-Fi DoC cites EN 301 489-17 V3.3.1, not EN 301 489-1.
- Retention is 10 years for most acts, at least 15 years only for implantable medical devices.
What a DoC is and what it is not
Section titled “What a DoC is and what it is not”The DoC is not a certificate issued by a third party. It is drawn up and signed by the manufacturer or by its authorised representative established in the Union (Blue Guide, section 4.4). The Blue Guide calls the CE marking "the visible consequence of a whole process comprising conformity assessment"; the DoC is the written statement of that outcome. The phrase "CE certificate" has no basis in the texts. Notified bodies (NBs) issue certificates, such as the EU-type examination certificate of module B, and point 7 of the DoC references them; they do not replace the declaration.
The common legal basis is Decision 768/2008/EC: Article R10 sets the duties (model structure of Annex III, continuous updating, translation), and Article 5 the single-declaration rule. Each sectoral act (RED, LVD, EMC, ATEX, machinery, medical devices) copies these into its own articles and annex. The Blue Guide 2022, section 4.4, is the Commission reading of the model.
The model declaration, point by point
Section titled “The model declaration, point by point”| Point | Decision 768/2008, Annex III | Blue Guide 2022, section 4.4 |
|---|---|---|
| 1 | "No ... (unique identification of the product)" | A number identifying the product; "does not need to be unique to each product"; may refer to a product, batch, type or serial number, and may be alphanumeric. Manufacturers may add a number for the declaration itself |
| 2 | Name and address of the manufacturer or his authorised representative | The one issuing the declaration |
| 3 | "This declaration of conformity is issued under the sole responsibility of the manufacturer" | |
| 4 | Object of the declaration (identification allowing traceability; may include a photograph) | An image is left to the manufacturer unless the act requires it |
| 5 | Conformity with the relevant harmonisation legislation | All relevant legislation complied with |
| 6 | References to harmonised standards used or other specifications | "Precise, complete and clearly defined": the version and/or date of each standard |
| 7 | Where applicable, the notified body (name, number), its intervention and the certificate | Only when a notified body was involved |
| 8 | Additional information | For example grade or category, if applicable |
| Signature | Signed for and on behalf of; place and date of issue; name, function, signature | Any date after completion of the conformity assessment; managing director or a person with delegated responsibility; signatory need not be domiciled in the EU |
The Blue Guide adds that the DoC "may take the form of a document, a label or equivalent", and that EN ISO/IEC 17050-1 can be used as guidance if it is in line with the applicable legislation.
How each act changes the model
Section titled “How each act changes the model”This is the table to keep at hand when one DoC has to satisfy several acts. "Number optional" refers to the footnote under each model.
| Act and model | Number for the DoC | Standards in point 6 | Notified body point | Specific items | DoC accompanies the product? |
|---|---|---|---|---|---|
| EMC 2014/30/EU, Annex IV | Optional | "Including the date of the standard" | Yes, where applicable (module B) | Colour image where necessary | No, on request (Blue Guide 4.4) |
| LVD 2014/35/EU, Annex IV | Optional | Harmonised standards or other specifications | None in the model | Colour image where necessary | No, on request |
| RED 2014/53/EU, Annex VI | Optional | "Identification number and version and, where applicable, date of issue" | Yes, EU-type examination certificate | Point 8: accessories and components, including software, covered by the DoC | Yes: copy or simplified DoC (Article 10(9)) |
| RoHS 2011/65/EU, Annex VI | No footnote; point 1 "unique identification of the EEE" | "Where applicable" | None | Point 5 names the Directive itself | No, on request |
| ATEX 2014/34/EU, Annex X | Optional | Harmonised standards or other specifications | Yes, where applicable | Image where necessary | Yes (Blue Guide 4.4) |
| Machinery 2006/42/EC, Annex II 1.A (until 19 January 2027) | Not addressed | Where appropriate, harmonised standards and other standards | Yes, for Annex IX type examination or Annex X full quality assurance | Person authorised to compile the technical file, established in the Community; typewritten or handwritten in capital letters | Yes |
| Machinery Regulation (EU) 2023/1230, Annex V Part A (from 20 January 2027) | Optional | Including "the date of the publication of the reference" in the OJ; parts applied if partial | Yes: module B with C, G or H | Point 9 states module A where used; installation address for some lifting machinery | Yes, or an internet address or machine-readable code in the instructions (Article 10(8)) |
| MDR (EU) 2017/745 and IVDR (EU) 2017/746, Annex IV | Not addressed | "References to any CS used" | Yes, with the procedure performed | SRN if issued, Basic UDI-DI, risk class, intended purpose | Not in the Blue Guide list |
Two consequences. First, a merged DoC under RED and RoHS should give each standard its version and date, because that satisfies both models. Second, the Machinery Regulation no longer asks for the person authorised to compile the technical file, which the Directive required; a DoC template carried over from 2006/42/EC should be revised for machines placed on the market from 20 January 2027.
EU Declaration of Conformity template
Section titled “EU Declaration of Conformity template”The template below covers a battery-powered IoT sensor with Wi-Fi 2.4 GHz, BLE and an 868 MHz short range device radio, under module A, with the references cited on 7 October 2026. It declares conformity with RED and RoHS only, for the reason given below the template. Square-bracket fields must be completed; fields marked [optional] can be removed.
Long form, single DoC for RED and RoHS
Section titled “Long form, single DoC for RED and RoHS”EU DECLARATION OF CONFORMITYNo [optional, for example DOC-[type]-[version]]
1. Radio equipment (product, type, batch or serial number): [Commercial name], type [type reference], [serial numbers from ...]
2. Name and address of the manufacturer [or authorised representative]: [Legal name], [postal address]
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration: [Description allowing traceability: hardware version, variants covered, for example "Wireless temperature and humidity sensor, Wi-Fi 2.4 GHz, BLE and 868 MHz radio, battery powered"] [optional: colour image where necessary for identification]
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: Directive 2014/53/EU (OJ L 153, 22.5.2014, p. 62) Directive 2011/65/EU (OJ L 174, 1.7.2011, p. 88), as amended
6. References to the relevant harmonised standards used or to the other technical specifications in relation to which conformity is declared: Article 3(1)(a): [RF exposure and electrical safety references applied, with version, as other technical specifications] Article 3(1)(b): EN 301 489-17 V3.3.1 (Wi-Fi, BLE) EN 301 489-3 V2.3.2 (868 MHz) Article 3(2): EN 300 328 V2.2.2 (2.4 GHz) EN 300 220-2 V3.3.1 (868 MHz) Article 3(3)(d): EN 18031-1:2024 Article 3(3)(e): EN 18031-2:2024 [where Article 3(3)(e) applies, for example personal data] RoHS: EN IEC 63000:2018
7. Notified body: not applicable (module A) [if module B: name, four-digit number, "performed the EU-type examination and issued the EU-type examination certificate", certificate reference]
8. Accessories and components, including software, covered: [firmware version or range; only items that influence conformity and that the user can install or change]
9. Additional information: [optional]
Signed for and on behalf of: [manufacturer legal name][place], [date of issue][name], [function] [signature]Why RED and RoHS only. RED Article 1(4) states that radio equipment "shall not be subject to Directive 2014/35/EU, except as set out in point (a) of Article 3(1)", and the EMC Directive excludes equipment covered by the radio directive (Article 2(2)(a)). The LVD safety objectives and the EMC protection requirements are met through RED Articles 3(1)(a) and 3(1)(b), so the declaration names 2014/53/EU, not 2014/35/EU or 2014/30/EU.
Why these standard references. The RED list is Annex I to Implementing Decision (EU) 2022/2191 as amended. EN 301 489-1 is not cited on its own; the cited parts are EN 301 489-17 V3.3.1 and EN 301 489-3 V2.3.2 (Decision (EU) 2025/893), each with two notices: no presumption for emissions below 9 kHz, and none if its clause 6 is applied. For 868 MHz, EN 300 220-2 V3.3.1 is cited by Decision (EU) 2025/2499, and V3.1.1 keeps its citation until 11 June 2027; V3.2.1 was never cited. EN 18031-1, -2 and -3:2024 are cited with restrictions by Decision (EU) 2025/138. For Article 3(1)(a), the RED list cites only EN 50360, EN 50385, EN 50401 and EN 50566; EN 62311, EN 62479 and EN 62368-1 are not in it, so if you use them they go in as other technical specifications. Full list and dates: RED harmonised standards.
Short form, RED simplified DoC (Article 10(9) and Annex VII)
Section titled “Short form, RED simplified DoC (Article 10(9) and Annex VII)”Article 10(9) requires "each item of radio equipment" to be accompanied by a copy of the DoC or by a simplified DoC. The simplified version "shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained". Annex VII fixes the wording:
Hereby, [Name of manufacturer] declares that the radio equipmenttype [designation of type of radio equipment] is in compliance withDirective 2014/53/EU.The full text of the EU declaration of conformity is available atthe following internet address: [exact internet address]Article 18(2) adds that the simplified DoC is translated into the language required by the Member State, is "continuously updated", and that the full text at that address is available in that language too. The directive sets no file format, login rule or hosting period for the page; the obligation is the exact address and a full text that matches the units sold. The RED-specific points are in RED technical file.
Directive-specific requirements
Section titled “Directive-specific requirements”RED 2014/53/EU, Annex VI
Section titled “RED 2014/53/EU, Annex VI”Annex VI follows Annex III with two changes: point 6 requires references "with their identification number and version and, where applicable, date of issue", and a new point 8 covers accessories and components, including software, covered by the DoC. The model does not require standards to be grouped by essential requirement; grouping them by Article 3(1)(a), 3(1)(b), 3(2) and 3(3) is good practice that makes the coverage easy to check. Since 1 August 2025, Articles 3(3)(d), (e) and (f) apply to the categories listed in Delegated Regulation (EU) 2022/30, so the DoC of such equipment lists them and the references applied, such as EN 18031-1, -2 or -3:2024. Frequency bands and maximum transmitted power belong in the instructions (Article 10(8)), and restrictions on putting into service go on the packaging and in the instructions (Article 10(10)); neither is a DoC item. See the RED checklist and the RED technical file.
LVD 2014/35/EU, Annex IV
Section titled “LVD 2014/35/EU, Annex IV”The LVD model has seven points and no notified body point: conformity is assessed by internal production control (Annex III), and the LVD involves no NB. For IT and audio-video equipment the cited edition is EN 62368-1:2014 with AC:2015; for household appliances, EN 60335-1:2012 up to A15:2021, with a restriction on clause 20.2 (Decision (EU) 2025/1457). EN IEC 60335-1:2023 is not cited. Give each reference with its edition and amendments.
EMC 2014/30/EU, Annex IV
Section titled “EMC 2014/30/EU, Annex IV”Article 14 allows internal production control (Annex II) or EU-type examination followed by conformity to type (Annex III), and the manufacturer may restrict the type examination to some aspects of the essential requirements. The model asks for each standard "including the date of the standard". For radio equipment the EMC Directive does not apply: its Article 2(2)(a) excludes equipment covered by the radio directive, and RED Article 3(1)(b) carries the EMC requirement, including for the non-radio functions of the product.
Machinery 2006/42/EC and Regulation (EU) 2023/1230
Section titled “Machinery 2006/42/EC and Regulation (EU) 2023/1230”Directive 2006/42/EC is repealed from 20 January 2027, the date from which Regulation (EU) 2023/1230 applies. A machine placed on the market from that date needs a DoC under Annex V Part A of the Regulation. The differences are in the table above: the Regulation drops the person authorised to compile the technical file, asks for the date of OJ publication of each harmonised standard reference and for the parts applied, and lets the manufacturer provide the DoC through "the internet address or machine-readable code" given in the instructions instead of a paper copy (Article 10(8)). For a model sold on both sides of the date, the Blue Guide (section 2.11) shows how a DoC may refer to an old and a new act with their periods of application, using the EMC recast as its example. See Machinery Directive 2006/42 and Regulation 2023/1230.
MDR (EU) 2017/745 and IVDR (EU) 2017/746
Section titled “MDR (EU) 2017/745 and IVDR (EU) 2017/746”Annex IV of each Regulation lists ten items: name and address of the manufacturer and, if applicable, its authorised representative, with the manufacturer SRN if already issued; the sole-responsibility statement; the Basic UDI-DI; product or trade name and intended purpose; the risk class under Annex VIII; the conformity statement; references to any common specifications used; where applicable, the notified body, the procedure performed and the certificates; additional information; place, date, name, function and signature. The DoC is kept for at least 10 years after the last device covered has been placed on the market, and at least 15 years for implantable devices (MDR Article 10(8)); the IVDR sets at least 10 years (Article 10(7)). See the MDR guide.
ATEX 2014/34/EU, Annex X
Section titled “ATEX 2014/34/EU, Annex X”The ATEX model follows Annex III and makes the number optional. The conformity assessment depends on group and category (Article 13): category 1 and M1 equipment needs EU-type examination with production quality assurance or product verification; category 2 and M2 electrical equipment and internal combustion engines need EU-type examination with one of two production modules; other category 2 and M2 equipment uses internal production control, with the technical documentation communicated to a notified body; category 3 uses internal production control. Point 7 is filled in whenever a notified body took part. Components get a written attestation of conformity, not a DoC (Article 13(3)). See the ATEX guide.
RoHS 2011/65/EU, Annex VI
Section titled “RoHS 2011/65/EU, Annex VI”RoHS uses module A (Article 7(b)), with no notified body. Its model has no numbering footnote, and point 5 names Directive 2011/65/EU itself. The cited standard for the technical documentation is EN IEC 63000:2018 (Implementing Decision (EU) 2020/659), EN 50581:2012 was withdrawn from 18 November 2021 and no longer gives presumption. See RoHS.
Single DoC or a dossier of DoCs
Section titled “Single DoC or a dossier of DoCs”The single declaration is not a preference of the Blue Guide but a legal rule: Article 5 of Decision 768/2008/EC, RED Article 18(3), the EMC and LVD Articles 15(3), ATEX Article 14(3), Machinery Regulation Article 21(3) and MDR Article 19(2) all require one DoC for all the acts that call for one, with their publication references. Recital 22 of the LVD and the Blue Guide (section 4.4) allow it to be "a dossier made up of relevant individual declarations of conformity", which is simpler when one act changes more often than the others. Either way, every applicable act has to be identified.
Languages
Section titled “Languages”The DoC "shall be translated into the language or languages required by the Member State in which the product is placed or made available" (Article R10(2); RED Article 18(2)). The languages are set nationally, and the texts do not require the translations to be certified. The Blue Guide (section 4.4) notes that the legislation does not always say who translates; if another operator produces the translation and does not have it signed by the manufacturer, "a copy of the original EU declaration of conformity signed by the manufacturer must also be provided together with the translated version". Under the Machinery Directive, the DoC and its translations follow the rules for the instructions (Annex II 1.A).
Signature and empowerment
Section titled “Signature and empowerment”The models require "signed for and on behalf of" the manufacturer, place and date of issue, name, function and signature. They name no job title. The Blue Guide (footnote 230) gives "the Managing Director of the company or another representative of the company to whom this responsibility has been delegated", and (footnote 231) states that the signatory need not be domiciled in the Union. The date may be "any date after the completion of the conformity assessment". The authorised representative may sign if the mandate covers it (Blue Guide 4.4); it may not draw up the technical documentation (Article R3(1)). The texts set no requirement on the signature technology; how a delegation of signing authority is recorded is an internal matter.
When the DoC must be updated
Section titled “When the DoC must be updated”Article R10(2) and each sectoral act require the DoC to be "continuously updated". The Blue Guide (section 4.4) is specific: one version of the DoC can apply to many units made in series, but "as soon as any of the elements of the EU declaration of conformity changes, the version of the EU declaration of conformity will have to be updated for products placed on the market after that change". Its examples: changes in the legislation, in the versions of the harmonised standards, or in the contact details of the manufacturer or authorised representative.
Typical triggers, each tied to a point of the model:
- a new version of a cited standard replaces the one you applied (point 6), for example EN 300 220-2 V3.1.1, which loses its citation on 11 June 2027;
- a hardware variant or firmware range is added to the declaration (points 1, 4 and, for RED, 8);
- a new act applies, such as the Machinery Regulation from 20 January 2027 (point 5);
- a notified body certificate is issued, renewed or changed (point 7);
- the manufacturer or authorised representative changes name or address (point 2).
Whether a design change needs a new assessment is a separate question, answered by the essential requirements and the component substitution rules; the DoC follows the result.
Retention and availability
Section titled “Retention and availability”| Who | Act | Period | Source |
|---|---|---|---|
| Manufacturer | EMC, LVD, RED, ATEX | 10 years after the product has been placed on the market | EMC Art. 7(3), LVD Art. 6(3), RED Art. 10(4), ATEX Art. 6(3) |
| Manufacturer | RoHS | 10 years after the EEE has been placed on the market | Art. 7(d) |
| Manufacturer | Machinery Regulation 2023/1230 | At least 10 years after placing on the market or putting into service | Art. 10(3) |
| Manufacturer | MDR | At least 10 years after the last device covered by the DoC; at least 15 years for implantable devices | Art. 10(8) |
| Manufacturer | IVDR | At least 10 years after the last device covered by the DoC | Art. 10(7) |
| Authorised representative | Acts based on Decision 768/2008 | Keeps the DoC and the technical documentation at the disposal of the authorities | Art. R3(2)(a) |
| Importer | Acts based on Decision 768/2008 | Keeps a copy of the DoC; ensures the file can be made available on request | Art. R4(8) |
For acts that count from "placed on the market", the Blue Guide (section 4.3) counts from each individual product, so in practice from the last unit of the model. Article 4 of Regulation (EU) 2019/1020 also requires, for products under the EMC Directive, the LVD, RED, RoHS, ATEX, the Machinery Directive and other listed acts, an economic operator established in the Union who verifies that the DoC has been drawn up and keeps it at the disposal of the authorities. Detail: authorised representative and importer obligations.
The Blue Guide (section 4.4) lists the acts that require the product to be accompanied by the DoC: machinery, equipment for potentially explosive atmospheres, radio equipment, measuring instruments, recreational craft, lifts, rail systems and air traffic management constituents. For a product under the EMC Directive, the LVD or RoHS only, the DoC is made available to the authorities on request.
Missing or incorrect DoC
Section titled “Missing or incorrect DoC”The aligned directives treat the DoC under "formal non-compliance": a DoC that "has not been drawn up" or "has not been drawn up correctly" is listed in RED Article 43(1), EMC Article 40(1), LVD Article 22(1) and ATEX Article 38(1). The Member State first requires the operator to put an end to it; if it persists, it "shall take all appropriate measures to restrict or prohibit" the product being made available, or ensure it is withdrawn or recalled. Penalties are laid down nationally and must be "effective, proportionate and dissuasive" (Regulation (EU) 2019/1020, Article 41). A DoC that cites a standard version no longer listed in the OJ does not void the declaration, but it gives no presumption of conformity for that requirement, and the file then has to demonstrate conformity by other means.
Dates that change a DoC in 2025 to 2027
Section titled “Dates that change a DoC in 2025 to 2027”| Date | Act | What changes in the DoC |
|---|---|---|
| 30 January 2025 | Implementing Decision (EU) 2025/138 | EN 18031-1, -2 and -3:2024 citable, with restrictions |
| 15 May 2025 | Implementing Decision (EU) 2025/893 | EN 301 489-17 V3.3.1 and EN 301 489-3 V2.3.2 cited with notices |
| 1 August 2025 | Delegated Regulation (EU) 2022/30 | RED Articles 3(3)(d), (e), (f) apply to the listed categories |
| 15 November 2026 | Implementing Decision (EU) 2025/893 | EN 301 489-52 V1.2.1 (cellular) loses its citation; V1.3.1 is cited |
| 20 January 2027 | Regulation (EU) 2023/1230 | Machinery DoC under Annex V Part A; Directive 2006/42/EC repealed |
| 11 June 2027 | Implementing Decision (EU) 2025/2499 | EN 300 220-2 V3.1.1 loses its citation; V3.3.1 is cited |
| 11 December 2027 | Cyber Resilience Act | Full application |
Claims the texts contradict
Section titled “Claims the texts contradict”| Common claim | What the text says |
|---|---|
| "Each DoC must carry a unique reference number." | The footnote to the EMC, LVD, RED, ATEX and Machinery Regulation models: assigning a number is optional. Point 1 identifies the product and "does not need to be unique to each product" (Blue Guide 4.4). |
| "Annex III has nine mandatory items." | It has eight numbered points plus the signature block; point 7 applies only where a notified body was involved. |
| "The DoC is signed by the CEO, the quality director or a person appointed by board resolution." | The models require name, function and signature "for and on behalf of" the manufacturer. The Blue Guide gives the managing director or a person with delegated responsibility as examples; the authorised representative may sign if mandated. |
| "The Blue Guide recommends a single aggregated DoC." | It is a legal requirement (Decision 768/2008 Article 5, RED Article 18(3), EMC and LVD Article 15(3)); the Blue Guide adds that it may be a dossier of individual DoCs. |
| "A RED DoC cites EN 301 489-1 V2.2.3, EN 301 489-17 V3.2.4 and EN 300 220-2 V3.2.1." | EN 301 489-1 is not cited on its own; EN 301 489-17 is cited as V3.3.1 (Decision 2025/893); EN 300 220-2 is cited as V3.3.1 (Decision 2025/2499) and V3.1.1 until 11 June 2027. V3.2.1 was never cited. |
| "EN 62368-1:2014+A11:2017 and EN IEC 62311 give presumption under RED Article 3(1)(a)." | Neither is in the RED list. Under the LVD the cited edition of EN 62368-1 is EN 62368-1:2014 with AC:2015. |
| "RED Annex VI requires the standards to be listed per essential requirement, otherwise there is no presumption." | Annex VI point 6 requires each reference with its identification number and version. Grouping by article is good practice, not a condition of the presumption of conformity. |
| "A RED DoC states the equipment class, the frequency bands and the Member State restrictions." | None is in Annex VI. Bands and maximum power go in the instructions (Article 10(8)); restrictions on the packaging and in the instructions (Article 10(10)). |
| "The simplified DoC is a supplement placed in the manual, and must be reachable without authentication at no cost." | It is an alternative to accompanying each item with a copy of the full DoC (Article 10(9)). The text requires the Annex VII wording and the exact internet address; it sets no access or format rule. |
| "Medical device DoCs of class IIa, IIb and III are kept 15 years." | MDR Article 10(8): at least 10 years, at least 15 years for implantable devices. The IVDR sets at least 10 years. |
| "ATEX module A is never usable for category 1 or 2." | Non-electrical category 2 and M2 equipment uses internal production control with the technical documentation communicated to a notified body (Article 13(1)(b)(ii)). |
| "The Machinery DoC must name a person authorised to compile the technical file." | True under Directive 2006/42/EC until 19 January 2027; Annex V Part A of Regulation (EU) 2023/1230 has no such item. |
| "Translations of the DoC must be certified." | Article R10(2) requires translation into the languages the Member State requires. The texts do not require certification. |
Further reading
Section titled “Further reading”- CE marking overview, cross-cutting rules and scope
- CE procedure, assessment modules and steps
- CE scope, which directives apply
- CE technical file, the file and the DoC compared act by act
- Technical documentation file: required contents, item by item
- Self-declaration vs notified body, choosing the module
- RED checklist, project in 6 phases
- RED harmonised standards, table by band
- Glossary, DoC, authorised representative, NB, UDI, OJEU
See also the common CE mistakes.
See also
Section titled “See also”- Certification test plan: template and checklist
- Choosing a Notified Body: NANDO and scope verification
- NB surveillance audits: cadence and conduct
- Conformity assessment modules A-H (768/2008/EC)
Sources & references
- Decision No 768/2008/EC, Article 5, Articles R2 to R10 and Annex III (model declaration), EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
- The Blue Guide on the implementation of EU product rules 2022 (2022/C 247/01), sections 2.11 and 4.4, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
- Directive 2014/53/EU (RED), Articles 10, 18, 43 and Annexes VI and VII, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
- Directive 2014/35/EU (LVD), Articles 6, 15, 22 and Annex IV, EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
- Directive 2014/30/EU (EMC), Articles 7, 14, 15, 40 and Annex IV, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
- Directive 2011/65/EU (RoHS), Articles 7 and 13 and Annex VI, EUR-Lex eur-lex.europa.eu/eli/dir/2011/65/oj
- Directive 2014/34/EU (ATEX), Articles 6, 13, 14, 38 and Annex X, EUR-Lex eur-lex.europa.eu/eli/dir/2014/34/oj
- Directive 2006/42/EC (Machinery), Annex II part 1.A, EUR-Lex eur-lex.europa.eu/eli/dir/2006/42/oj
- Regulation (EU) 2023/1230 on machinery, Articles 10 and 21 and Annex V, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
- Regulation (EU) 2017/745 (MDR), Articles 10 and 19 and Annex IV, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
- Regulation (EU) 2017/746 (IVDR), Articles 10 and 17 and Annex IV, EUR-Lex eur-lex.europa.eu/eli/reg/2017/746/oj
- Regulation (EU) 2019/1020 on market surveillance, Articles 4 and 41, EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
- Implementing Decision (EU) 2022/2191, the RED harmonised standards list, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2022/2191/oj
- Implementing Decision (EU) 2025/893, EN 301 489-3 V2.3.2 and EN 301 489-17 V3.3.1 cited with notices, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/893/oj
- Implementing Decision (EU) 2025/2499, EN 300 220-2 V3.3.1 cited, V3.1.1 withdrawn from 11 June 2027, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/2499/oj
- Implementing Decision (EU) 2025/138, EN 18031-1, -2 and -3 cited with restrictions, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/138/oj
- Implementing Decision (EU) 2020/659, EN IEC 63000:2018 cited under RoHS, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2020/659/oj
Frequently asked questions
- Is the EU Declaration of Conformity the same thing as the CE marking?
- No. The CE marking is the mark affixed to the product. The EU declaration of conformity (DoC) is the document by which the manufacturer states that fulfilment of the applicable requirements has been demonstrated and, by drawing it up, "shall assume responsibility for the compliance of the product" (Decision 768/2008/EC, Article R10). The Blue Guide 2022 calls the CE marking "the visible consequence" of that process. No act provides for a "CE certificate"; a notified body issues certificates such as the EU-type examination certificate, which the DoC then references.
- Can a single DoC cover several directives?
- It must. Where a product is subject to more than one Union act requiring a DoC, "a single EU declaration of conformity shall be drawn up in respect of all such Union acts", identifying each with its publication reference (RED Article 18(3), EMC and LVD Article 15(3), Decision 768/2008 Article 5). The Blue Guide (section 4.4) accepts that this single declaration may be a dossier made up of the individual declarations.
- Must the DoC carry a unique number?
- No. The footnote to the EMC, LVD, RED, ATEX and Machinery Regulation models states that assigning a number to the declaration is optional. Point 1 is a number identifying the product, which the Blue Guide says "does not need to be unique to each product" and may refer to a product, batch, type or serial number.
- How long must the DoC be kept?
- 10 years after the product has been placed on the market under the EMC Directive, the LVD, RED, ATEX and RoHS; at least 10 years under Machinery Regulation (EU) 2023/1230 and under the IVDR; at least 10 years under the MDR, and at least 15 years for implantable devices (MDR Article 10(8)). The Blue Guide counts the period from each individual product placed on the market, so in practice from the last unit.
- Who signs the DoC?
- The models require the name and function of the signatory, a signature, and the words "signed for and on behalf of" the manufacturer. The Blue Guide gives "the Managing Director of the company or another representative of the company to whom this responsibility has been delegated" as examples, and states that the signatory need not be domiciled in the EU. The authorised representative may draw up and sign the DoC if its mandate covers it.
- Does the RED simplified DoC replace the full DoC?
- It replaces the copy that has to accompany each item, not the full DoC. RED Article 10(9) requires each item to be accompanied by a copy of the DoC or by a simplified DoC, which must contain "the exact internet address where the full text of the EU declaration of conformity can be obtained". The wording is fixed by Annex VII, and the full text must be available at that address in the language required by the Member State (Article 18(2)).
- When must a new version of the DoC be issued?
- The DoC "shall be continuously updated" (Article R10(2) and each sectoral act). The Blue Guide (section 4.4) states that as soon as any element of the DoC changes, the version must be updated for products placed on the market after that change, giving changes in legislation, in the versions of harmonised standards or in the contact details of the manufacturer as examples.
- What happens if the DoC is missing or wrong at an inspection?
- A DoC that "has not been drawn up" or "has not been drawn up correctly" is formal non-compliance (RED Article 43, EMC Article 40, LVD Article 22, ATEX Article 38). The Member State requires the operator to end it; if it persists, the authority restricts or prohibits making the product available, or ensures it is withdrawn or recalled. Penalties are set nationally under Article 41 of Regulation (EU) 2019/1020.