I. Defining the Declaration
What defines the declaration? Based on EU practices regarding Declarations of Conformity, the definition covers these aspects: Definition—The EU Declaration of Conformity (EU DoC) is a document in which the manufacturer (or their authorized representative within the EEA) declares that their product meets all necessary requirements of applicable EU harmonized regulations;
Responsibility—The manufacturer must draft the EU DoC to declare their sole responsibility for compliance with relevant regulations or directives (the DoC must include manufacturer details such as name and address, basic product characteristics, the identification number of the Notified Body if applicable, and a legally binding signature on behalf of the organization); Status—The CE mark is a visible symbol indicating that the manufacturer has taken all necessary measures to ensure product compliance (affixing the CE mark declares that the product meets applicable European legal requirements); Issuance—The Declaration of Conformity is issued under the sole responsibility of the manufacturer (or installer); Mandatory Nature—Manufacturers must draft a Declaration of Conformity regardless of whether a Notified Body is involved; Documentation—The DoC typically forms part of the CE technical documentation alongside the product’s technical file; Translation—The declaration must be translated into the language(s) required by the Member State where the product is placed on the market. In summary, the definition encompasses six key aspects: the definition of the EU DoC, sole responsibility, the CE mark, issuance under sole responsibility, the mandatory requirement regardless of Notified Body involvement, and translation requirements.
II.
Core Elements
What are the core elements?
Regarding the practical application of Declaration of Conformity (DOC) elements, consider the following: The “Seven Elements”—a complete DOC must include seven key components: Manufacturer information (full company name, registered address, contact details; non-EU enterprises must list their EU Authorized Representative); Product identification (name, model number, and a unique code for batch/serial traceability); Applicable EU regulations/directives (e.g., CE-LVD 2014/35/EU, CE-MD 2006/42/EC); Harmonized standards applied (e.g., EN 62368-1 for audio/video safety); Statement of legal validity (declaring the product meets all applicable EU requirements and accepting legal liability for the declaration’s content); Information—the declaration must include: Your name and full business address (or that of the authorized representative), product serial number/model/type identifier, a statement accepting full responsibility, product identification methods allowing for traceability (may include images), details of the Notified Body involved in conformity assessment (if applicable), relevant regulations and harmonized standards/specifications used to demonstrate conformity, your name and signature, and the date of signing; Identification—Product identification number (referring to batch, type, or serial number), manufacturer name and address, name and address of the EU Authorized Representative (where necessary), a clause stating the declaration is prepared under the manufacturer’s sole responsibility, product description and identification info (photos may be attached), and references to all applicable EU legislation; Specifications—Product name (including specifications/model), product classification (e.g., Class IIa/IIb), statement of conformity with MDD and relevant regulations, manufacturer name and address, EU Authorized Representative name and address, CE certificate number (if applicable), and place and date of signature; Identification—Traceability methods (may include images)—Summary of the six aspects: Seven elements, statement of sole responsibility, product identification number, specifications/model/classification, CE certificate number, and place/date of signature;
ensure all six aspects are complete.
III. Mechanical Structure
What to look for regarding mechanical structure.
Based on the structural requirements of the Machinery Directive, the structure is as follows: Nine items—Annex II of 2006/42/EC stipulates that the EC Declaration of Conformity must include: (1) business name and full address of the manufacturer and, where appropriate, the authorized representative; (2) name and address of the person authorized to compile the technical file, who must be established within the Community; (3) description and identification of the machinery, including generic name, function, model, type, serial number, and trade name; (4) a sentence expressly declaring that the machinery fulfills all relevant provisions of the Directive and, where appropriate, a declaration of conformity with other Directives; (5) name and address of the authorized representative established within the Community, where appropriate; (6) for machinery listed in Annex IV: name, address, and identification number of the Notified Body that carried out the EC type-examination (Annex IX) and the EC type-examination certificate number, or the name, address, and identification number of the Notified Body that approved the full quality assurance system (Annex X); (7) references to applicable harmonized standards, where appropriate; (8) references to the EC type-examination certificate or full quality assurance approval for Annex IV machinery, where applicable; (9) place and date of signature (Annex II of 2006/42/EC); Format—the declaration and its translation must be drawn up under the same conditions as the instruction manual (must be typed or handwritten in capital letters; Annex II); Scope—the declaration relates only to the machinery in the state in which it is placed on the market (excluding components added and/or operations carried out subsequently by the final user; Annex II); Compiler—the person authorized to compile the technical file must be established within the Community (ensuring that, should EU supervisory authorities detect signs of falsification in the CE certificate or declaration, find that the machinery fails to meet relevant EU Directive requirements, or encounter a safety incident, this responsible person can be contacted immediately within the EU; China Public Service Platform for Technical Barriers to Trade); Additional—additional information for Annex IV machinery (name, address, and identification number of the Notified Body that carried out the EC type-examination [Annex IX] and the EC type-examination certificate number, or the name, address, and identification number of the Notified Body that approved the full quality assurance system [Annex X]; name and address of the person authorized to compile and transmit the technical file in response to reasoned requests; CECE guidance); Updates—the EU Declaration of Conformity should follow the model structure set out in Annex V, Part A (and include Annexes VI, VIII, IX…
…elements specified in relevant modules, continuous updates, translation into the language(s) required by the member state(s) where the product is placed on the market, and compliance with Regulation (EU) 2023/1230—”Six Aspects of Structure”: nine elements, typed or handwritten, market placement status, compiler details, Notified Body (Annex IV), and continuous updates/translations;
these six aspects ensure structural completeness.
IV. Signing Requirements
What to look for regarding signing requirements.
Based on practices for signing Declarations of Conformity, the signing process involves these aspects: Signature—the declaration must be signed by personnel from the manufacturer or their authorized representative (including the staff member’s job title); Legal—a legally binding signature representing the organization; Personnel—the person responsible for the declaration (full name, importer details, job title, legal signature, location, date); Location—place and date of signing (Directive 2006/42/EC, Annex II, Item 9); Sole Responsibility—the declaration is issued under the sole responsibility of the manufacturer (Annex III); Translation—the declaration and its translation must be drafted under the same conditions as the instruction manual (must be typed or handwritten in capital letters, Annex II); Continuity—the declaration is continuously updated (Regulation (EU) 2023/1230)—”Six Aspects of Signing”: staff signature, legally binding signature, responsible person’s title, signing location and date, sole responsibility, and typed/capitalized text; these six aspects ensure signing compliance.
V.
Associated Record-Keeping
What to look for regarding associated record-keeping.
Regarding the supporting practices for the Declaration of Conformity, the requirements are as follows: **Bundling**—The DoC typically forms the CE technical documentation alongside the product’s technical files (Liaoning Provincial Administration for Market Regulation); **Retention**—Manufacturers must retain technical files and the EU Declaration of Conformity for market surveillance authorities for at least 10 years (after the machine or related product is placed on the market; 2023/1230); **Authorization**—Authorized representatives must retain the EU Declaration of Conformity and technical files for national market surveillance authorities for 10 years (after the equipment is placed on the market; 2014/30/EMC); **Object of Declaration**—The object of the declaration is the product identifier that allows for traceability (Annex III); **Partially Completed Machinery**—Before placing the product on the market, the manufacturer or authorized representative must ensure that relevant technical files and assembly instructions are prepared, a declaration of incorporation is drafted, and the assembly instructions and declaration of incorporation accompany the partially completed machinery until it is integrated into the final machine (2006/42/EC); **Identity**—Product identification (name, model, batch number/unique traceable code; Trade Enterprise Connect); **Cooperation**—All necessary information and documents must be provided upon the reasonable request of competent national authorities (proof of product conformity in paper or digital format; 2023/1230). In summary, the six supporting aspects form a closed-loop system: technical documentation bundling, 10-year retention, retention by authorized representatives, declaration of incorporation for partially completed machinery, traceable coding, and provision of proof.
Conclusion
How should a Declaration of Conformity for automation components be drafted?
The conclusion is to define the standards based on five dimensions: positioning, elements, structure, signing, and supporting requirements.
Definition—The EU Declaration of Conformity (DoC) is a statement by the manufacturer or an authorized representative within the EEA confirming that the product meets all essential requirements of relevant EU harmonized regulations; it is issued under the manufacturer’s sole responsibility, must be drafted regardless of whether a Notified Body is involved, and forms part of the CE technical documentation alongside the technical file. Key Elements—Seven elements: manufacturer details (full company name, registered address, contact info, plus authorized representative), product identification (name, model, batch number), applicable regulations/directives (e.g., CE-LVD 2014/35/EU, CE-MD 2006/42/EC), harmonized standards, a statement of legal validity, and the place and date of signing. Structure—Based on the nine items in Annex II of Directive 2006/42/EC: manufacturer’s full name and address; details of the person authorized to compile the technical file (established within the Community); machine description/identification (generic name, function, model, type, serial number, trade name); explicit declaration of conformity; authorized representative details; Annex IV details (Notified Body name, address, ID number, certificate number); harmonized standards; certificate references; and place/date of signing. Formatting—Typed or handwritten in capital letters; applies only to the machine as placed on the market; requires ongoing updates and translation. Signing—Signed by the manufacturer or authorized representative personnel (with job title indicated); legally binding signature on behalf of the organization; issued under sole responsibility. Supporting Requirements—Retained for 10 years alongside the technical file; kept by the authorized representative;
“Declaration of Incorporation” drafted for partly completed machinery and supplied with the unit; proof provided upon regulatory request.
Industry Best Practice—A summary of the DoC: issued under sole responsibility, includes all seven key elements and the nine Annex II items, signed with job title indicated, and retained for 10 years—meet these five criteria, and the declaration is compliant.
