Can a single DoC cover several directives?

Yes, and it is in fact the practice recommended by the Blue Guide. A typical radio product falls under RED, RoHS and, by cross-reference, LVD and EMC at the same time. A single aggregated DoC listing every applicable directive and every harmonised standard used is easier to read for market-surveillance authorities than a stack of separate DoCs. The DoC has a unique reference number that is incremented at every substantive revision.

How long must the DoC be archived?

10 years after the last unit of the model covered was placed on the market, for most directives (RED, EMC, LVD, RoHS, Machinery). Some sectoral legislation imposes a longer period, for instance 15 years for implantable medical devices under MDR. The DoC is kept with the full technical file (Annex V for RED), ready to be presented on demand to any market-surveillance authority of any Member State.

Who signs the DoC inside the company?

A person duly empowered by the manufacturer, whose function (job title) must be stated next to the name and the signature. In practice, the signatory is the CEO, the quality director, the regulatory affairs lead or a representative appointed by board resolution. The internal chain of delegation must be archived and presentable. The directive does not impose a specific job title, but the person signing legally binds the manufacturer.

Does the RED Article 10(9) simplified DoC replace the full DoC?

No, it complements it. The simplified DoC is a short statement authorised for radio equipment, placed in the user manual or on the packaging. It includes a URL pointing to the full DoC, which must remain accessible without authentication and without any cost. The manufacturer keeps both versions at the disposal of market surveillance.

Does a firmware update trigger a new DoC?

Yes, if it affects essential requirements. A change in transmit power, modulation, frequency band, spectrum-access mechanism, or a substantive change in the cybersecurity Article 3.3 scope, requires a fresh assessment, an update of the cited standard references, and issuance of a new dated DoC, with version increment. Purely cosmetic or bug-fix updates do not trigger an increment.

In which languages must the DoC be drafted?

The DoC must be drafted or translated into the official language(s) required by each Member State where the product is made available. For France, French is required. The practical rule is to keep an original version (usually English) plus as many certified translations as there are target countries. The RED simplified DoC in the manual follows the same language rule as the manual itself.

What happens if the DoC is incomplete or missing during an inspection?

Absence or incompleteness of the DoC is a formal non-conformity that can trigger, under Regulation (EU) 2019/1020, corrective measures (bring into compliance within a set time frame), market withdrawal, recall of units already sold, and administrative or criminal sanctions depending on national law. A DoC that omits an applicable directive or cites a standard in an obsolete version exposes the manufacturer to the same level of risk as a missing DoC.

EU Declaration of Conformity (DoC): template and mandatory content

Q: Is the EU Declaration of Conformity the same thing as the CE marking?

No. The CE marking is the visible mark affixed to the product, its packaging and its user manual. The EU Declaration of Conformity (DoC) is the written document by which the manufacturer attests, under sole responsibility, that the product complies with all applicable Union harmonisation legislation. The CE marking is the visible consequence, the DoC is the documentary evidence behind it. No body ever issues a "CE certificate", a phrase that has no legal basis but is still common in B2B procurement language.

Author Hugues Orgitello Last updated 26 May 2026

Guide · EU Declaration of Conformity

The EU Declaration of Conformity (DoC) is the document by which the manufacturer, or its authorised representative established in the Union, attests under sole responsibility that the product complies with all applicable Union harmonisation legislation. It is drawn up before the product is placed on the market, kept for 10 years, and held at the disposal of market-surveillance authorities. This page covers the mandatory content, provides a copy-paste aggregated multi-directive template, and details the specifics of RED, LVD, EMC, Machinery, MDR, ATEX and RoHS.

What a DoC is and what it is not

The DoC is not a certificate issued by a third party. No body, no laboratory, no administration signs the DoC. It is signed by a duly empowered person inside the manufacturer, or inside its authorised representative if the manufacturer is established outside the EU. The CE marking affixed to the product is the visible consequence of the DoC, not the other way around. The phrase "CE certificate", widely used in public procurement and B2B language, has no legal basis. EU type-examination certificates do exist, issued by notified bodies (NBs) under Module B, and they are referenced inside the DoC, but they do not replace it.

The common legal basis is Decision 768/2008/EC whose Annex III defines the minimum content shared by every DoC under the New Legislative Framework. Each vertical directive (RED, LVD, EMC, Machinery, ATEX, MDR, etc.) restates this content in its own annex and adds directive-specific items. The Blue Guide 2022 explicitly encourages the use of a single aggregated DoC rather than a stack of separate DoCs.

Common mandatory content (Decision 768/2008, Annex III)

Every DoC, regardless of the directive, must contain at least the nine items below.

Item	Content	Legal source
1	Unique identification of the product, reference, model, type, batch or serial number	Decision 768/2008, Annex III
2	Name and full postal address of the manufacturer and, where applicable, of the authorised representative	Same
3	Statement: "This declaration of conformity is issued under the sole responsibility of the manufacturer"	Same
4	Object of the declaration, description sufficient to allow product traceability (text, photo if helpful)	Same
5	Union harmonisation legislation applicable, exhaustive list of directives and regulations referred to, with numbering	Same
6	References to the relevant harmonised standards used, with date and version, or to other technical specifications	Same
7	Notified body name, 4-digit identification number and certificate it issued, where applicable	Same
8	Additional information specific to each directive (e.g. RED Annex VI)	Vertical annexes
9	Signature, place, date, name and function of the signatory, handwritten or electronic signature	Decision 768/2008, Annex III

Every item is mandatory. The absence of an item is a formal non-conformity, sanctionable under Regulation (EU) 2019/1020 on market surveillance.

EU Declaration of Conformity template

The template below is drafted in aggregated multi-directive form. It covers a typical IoT radio product (Wi-Fi 2.4 GHz + BLE + sub-GHz) falling under RED, RoHS and, by cross-reference, LVD and EMC. Adapt to the directives actually applicable to your product. Square-bracket fields must be completed. Fields marked [optional] should only be kept if relevant.

Long form, aggregated multi-directive DoC

EU DECLARATION OF CONFORMITY

DoC number: [DOC-YYYY-NNN]
Version: [vX.Y]                       Date of issue: [DD/MM/YYYY]
Previous revision: [reference or "n/a"]

1. PRODUCT (object of the declaration)
   Designation: [Commercial product name]
   Model / type: [Catalogue reference]
   Variants covered: [List of SKUs / HW variants]
   Batch or serial number: [Range covered or identification rule]
   Description: [1 to 3 lines, e.g. "Wireless sensor for the
   measurement of temperature and humidity, Wi-Fi 2.4 GHz, BLE 5.x
   and LoRa 868 MHz radio interfaces, 3.6 V Li-SOCl2 battery
   powered"]
   Photo / illustration: [optional, see annex or next page]

2. MANUFACTURER
   Legal name: [Full legal name]
   Postal address: [Street, postcode, city, country]
   Registration number: [VAT, company registry or equivalent,
   optional]
   Website / contact: [URL, email]

3. AUTHORISED REPRESENTATIVE [optional, mandatory if
   manufacturer is established outside the EU]
   Legal name: [Legal name of the EU representative]
   Postal address: [Street, postcode, city, Member State]
   Mandate dated: [DD/MM/YYYY]

4. STATEMENT OF SOLE RESPONSIBILITY
   This declaration of conformity is issued under the sole
   responsibility of the manufacturer.

5. OBJECT OF THE DECLARATION
   The object of the declaration described above is in conformity
   with the relevant Union harmonisation legislation:

   - Directive 2014/53/EU (RED), radio equipment
   - Directive 2011/65/EU (RoHS) and Delegated (EU) 2015/863
   - [Add if applicable: 2014/30/EU EMC, 2014/35/EU LVD,
     2006/42/EC Machinery, 2014/34/EU ATEX, (EU) 2017/745 MDR,
     etc.]

6. REFERENCES TO THE HARMONISED STANDARDS USED
   The following harmonised standards have been applied (exact
   versions cited in the OJEU at the date of this DoC):

   Article 3.1(a) health and safety:
   - EN 62368-1:2014+A11:2017
   - EN IEC 62311:2020 (electromagnetic field exposure)

   Article 3.1(b) electromagnetic compatibility (radio):
   - EN 301 489-1 V2.2.3 (2019-11)
   - EN 301 489-17 V3.2.4 (2020-09) [Wi-Fi, BLE]
   - EN 301 489-3 V2.1.1 (2019-03) [sub-GHz]

   Article 3.2 efficient use of the spectrum:
   - EN 300 328 V2.2.2 (2019-07) [2.4 GHz Wi-Fi/BLE]
   - EN 300 220-2 V3.2.1 (2018-06) [sub-GHz non-specific]

   Article 3.3 (d/e/f) cybersecurity [from 1 August 2025]:
   - EN 18031-1:2024
   - EN 18031-2:2024 (if personal data processing)
   - EN 18031-3:2024 (if monetary functions)

   Other directives:
   - EN IEC 63000:2018 (RoHS, technical documentation)

7. NOTIFIED BODY [optional, if Module A1, B+C or H]
   Name: [Name of the notified body]
   Identification number: [4-digit, e.g. 0123]
   Scope of intervention: [EU type examination / Quality system
   audit]
   Certificate issued: [Certificate reference, e.g. CT-12345-RED]
   Date of certificate: [DD/MM/YYYY]

8. ADDITIONAL INFORMATION
   - RED equipment category: [class 1 or class 2]
   - Frequency band(s) and maximum transmit power:
     [e.g. 2400-2483.5 MHz, 100 mW EIRP max]
   - Possible restriction(s) on placing on the market: [list of
     Member States concerned or "none"]
   - Technical file kept at the disposal of authorities by: [Name
     and address]

9. SIGNATURE
   Signed for and on behalf of: [Manufacturer legal name]
   Place: [City]                       Date: [DD/MM/YYYY]
   Name: [First name Last name]
   Function: [e.g. Chief Executive Officer, Regulatory
   Compliance Manager, Quality Director]
   Signature: ______________________

Short form, RED Article 10(9) simplified DoC

Article 10(9) of Directive 2014/53/EU allows, for radio equipment, a simplified DoC placed in the user manual or on the packaging, provided it points to the full DoC. Conditions, the simplified DoC must state the manufacturer name, identify the product, declare conformity with the directive, and provide a URL pointing to the full DoC, which must remain available without authentication and at no cost.

SIMPLIFIED EU DECLARATION OF CONFORMITY (RED Article 10(9))

Hereby, [Manufacturer legal name] declares that the radio
equipment type [model reference] is in compliance with
Directive 2014/53/EU.

The full text of the EU declaration of conformity is available
at the following internet address:

   [https://www.example.com/doc/MODEL-XYZ.pdf]

The text must appear in the language required by each Member State of availability. The target page must serve a stable signed PDF/A, hosted on a domain controlled by the manufacturer for the full retention period (10 years). A transient URL (shortener, third-party platform) is not acceptable.

Directive-specific requirements

RED 2014/53/EU, Annex VI

Annex VI specifies the DoC content for radio equipment. It explicitly requires a reference to the harmonised standards used for each of the essential requirements of Articles 3.1(a), 3.1(b), 3.2 and, since 1 August 2025, 3.3. A RED DoC that only cites the directive without breaking down the standards per article is incomplete, and the presumption of conformity cannot be invoked. See the RED checklist and the RED technical file structure.

RED-specific extra items, equipment category (class 1 or 2), frequency bands and transmit powers, restrictions on placing on the market by Member State, NB name and 4-digit number if Module A1/B+C/H is used.

LVD 2014/35/EU, Annex IV

Annex IV restates the common structure. The only allowed assessment module is A (self-declaration), no notified body ever intervenes under LVD. Typical standards, EN 62368-1 for audio/video and IT equipment, EN 61010-1 for laboratory equipment, EN 60335-1 for household appliances. Cite the exact version.

EMC 2014/30/EU, Annex IV

Same structure as LVD. Module A only. Typical standards EN 55032 (emissions), EN 55035 (immunity) for multimedia equipment, EN 61000-6-x for generic environments (residential, industrial). For products with an integrated radio function, the EMC requirement is covered by RED via Article 3.1(b), and Directive 2014/30/EU only applies to the non-radio parts.

Machinery 2006/42/EC and Regulation (EU) 2023/1230

Machinery Directive 2006/42/EC is being replaced by Regulation (EU) 2023/1230, applicable as of 20 January 2027. During the transition, both regimes coexist depending on placing-on-the-market date. The Machinery DoC adds two specific items, identification of the person authorised to compile the technical file (with an EU address), and where relevant, the reference to the conformity assessment procedure for machines listed in Annex IV (higher-risk categories, some requiring a notified body).

MDR (EU) 2017/745 and IVDR (EU) 2017/746

The medical device DoC follows the format of Annex IV (MDR) and Annex IV (IVDR). It must include the basic UDI-DI (Unique Device Identifier, Device Identifier of basic identification) of the product, the classification (I, IIa, IIb, III for MD, A to D for IVD), the manufacturer's SRN (Single Registration Number), and the NB certificate number for class IIa and above. The retention period is 15 years after the last unit was placed on the market for classes IIa, IIb, III. The DoC is uploaded to EUDAMED.

ATEX 2014/34/EU

The ATEX DoC cites the equipment category (group I/II, category 1/2/3, gas zone G or dust D), the full Ex marking (e.g. II 2 G Ex db IIB T4 Gb), the EN 60079-x harmonised standards used, and the NB number that issued the EU type-examination. ATEX requires an NB for almost all products except category 3 with no serious risk, Module A is never usable for category 1 or 2 equipment.

RoHS 2011/65/EU

RoHS is usually included in the aggregated DoC. The supporting evidence is EN IEC 63000, which details the RoHS technical documentation (supplier declarations, material analyses, substance management). No NB intervenes under RoHS, Module A only.

Single DoC or separate DoCs

The Blue Guide and current practice converge on the single aggregated DoC. Advantages, readability for surveillance authorities, single document to maintain, simpler traceability between standards and directives. Limits, the document becomes long for products under more than five directives, in which case some teams keep one DoC per directive family (radio + electrical safety on one side, RoHS on the other). Whatever the choice, every applicable directive must be cited by name in at least one DoC, and the full set of DoCs must be archived.

Required languages

The DoC must be translated into the official language(s) of every Member State where the product is made available. The original language is free (usually English for products with an international footprint). Translations must remain faithful, in case of discrepancy, the version in the language of the concerned Member State prevails for local authorities. The RED simplified DoC in the user manual follows the same language rule as the manual. In practice, a manufacturer targeting the 27 Member States keeps 24 language versions (some countries share a language).

Signature and empowerment

The directive does not impose a specific function on the signatory, but it requires that the function of the signatory be stated next to the name and the signature. The signatory legally binds the manufacturer. Typical roles, CEO, quality director, head of regulatory affairs, product compliance manager. In groups, a formal delegation of authority (board resolution or written delegation) must back the signature, archived together with the DoC. An advanced or qualified electronic signature in the sense of eIDAS Regulation (EU) 910/2014 is admissible and improves traceability.

Versioning and change management

The DoC carries a unique number and a date. Any substantive change in the product or in the regulatory baseline triggers issuance of a new dated DoC, with version increment. Typical increment triggers,

firmware update affecting transmit power, modulation, band, spectrum-access mechanism, or 3.3 scope ;
addition or removal of a hardware variant (SKU variant covered) ;
publication in the OJEU of a new version of an applied harmonised standard, after assessment ;
addition or removal of an applicable directive, for instance following a regulatory change (RoHS exemption lifted, MDR transition, etc.) ;
substitution of a critical component (radio module, antenna, power supply) that required a reassessment.

The change-management procedure that ties each DoC increment to a regulatory impact note is itself archived in the technical file.

Archiving and availability

The DoC must be archived for 10 years after the last unit was placed on the market of the model concerned, for most directives. It is held at the disposal of the market-surveillance authorities of any Member State, in accordance with Regulation (EU) 2019/1020. The typical lead time to produce the DoC on request is a few working days, so the manufacturer needs an operational archiving system for the whole retention period. Longer sectoral periods, MDR class IIa+ and IVDR class C+, 15 years.

The archiving system covers, the signed DoC itself (signed PDF/A), every previous version, the referenced test reports, NB certificates, the full technical file (RED Annex V or equivalent), language translations, web pages serving simplified DoCs with their persistent URLs.

Common mistakes

Mistake	Typical cause	Risk
Missing applicable directive	Incomplete regulatory analysis	DoC deemed void, withdrawal possible
Standard cited in an obsolete version	No OJEU monitoring	Presumption of conformity invalid
No per-article reference (RED)	Generic copy-pasted DoC	Annex VI non-conformity
Non-persistent URL on simplified DoC	Third-party hosting, shortener	Simplified DoC invalid
Function of signatory missing	Outdated template	Formal non-conformity
4-digit NB number missing	Confusion with the certificate number	Incomplete DoC, audit fail
No version / no date	DoC treated as a static document	Cannot trace amendments
Missing national-language translation	Target country not identified	Customs rejection, commercial block

See also the common CE mistakes and the full CE procedure for the broader context.