I. Responsible Parties
How to identify the responsible party? Based on EU Machinery Regulation practices, the party is determined as follows: Manufacturer—The CE mark is affixed to the product by the manufacturer (affixing the mark declares compliance with applicable European legal requirements; the manufacturer bears sole responsibility for verifying that goods sold meet all relevant regulations and, where necessary, having them inspected by a Notified Body for conformity assessment; European Commission MEMO);
Responsibilities—Manufacturer’s obligations (providing necessary information such as instruction manuals; conducting conformity assessment under Article 12; drafting the EC Declaration of Conformity in accordance with Annex II, Part 1, Section A and ensuring it accompanies the machine; affixing the CE mark under Article 16; Article 5 of 2006/42/EC); Regulations—EU Machinery Regulation 2023/1230 replaces 2006/42/EC (adopted June 14, 2023; OJ L 165; version retrieved Sept 30, 2026); Procedures—After demonstrating compliance with the essential health and safety requirements of Annex III through conformity assessment procedures, the manufacturer must draft the EU Declaration of Conformity and affix the CE mark under Article 24 (2023/1230); Partly completed machinery—Before placing partly completed machinery on the market, the manufacturer or their authorized representative must prepare technical documentation (2006/42/EC); Importer—When neither the manufacturer nor the authorized representative is established within the Community, the responsibility for retaining technical documentation falls on the person placing the product on the Community market (31993D0465); Liability—The manufacturer bears sole responsibility for verifying that goods comply with all relevant regulations (European Commission)—Six key aspects regarding the party: manufacturer labeling, manufacturer obligations, replacement by new regulations, Declaration of Conformity, partly completed machinery, and the liability of the person placing the product on the market; these six points clarify the responsible party.
II. Who Compiles It
Determining who compiles it involves several factors.
Based on CE technical documentation practices, the compilation responsibilities are defined as follows: Manufacturer—Before drafting the EC Declaration of Conformity, the manufacturer or their authorized representative established within the Community must prepare the technical documentation (physical copies of all documents need not be permanently available, but they must be producible upon request; detailed plans of sub-components used to manufacture the machine are not required unless essential for verifying compliance with essential health and safety requirements; Directive 2006/42/EC); Authorization—The authorized representative must perform the tasks specified in the mandate received from the manufacturer (the mandate must, at a minimum, allow the representative to: keep the EU Declaration of Conformity and technical documentation available for national market surveillance authorities for 10 years; and provide all necessary information and documentation to demonstrate conformity upon the reasoned request of competent national authorities; Directive 2014/30/EMC); Exclusions—The authorized representative must fulfill the obligations specified by the manufacturer (unless the written mandate states that the manufacturer has transferred authority to the representative), with the exception of drafting the technical documentation (Article 5 of Turkish CE regulations); Compiler—The name and address of the person authorized to compile the technical documentation (must be established within the Community; Teknologisk CE guidelines); Requirements—The technical documentation must demonstrate that the machine complies with the Directive’s requirements (covering the design, manufacture, and operation necessary for assessment; prepared in one or more official Community languages; specific provisions for instruction manuals apply—Annex I, Section 1.7.4; Annex VII of Directive 2006/42/EC); Commissioning/Placement—The manufacturer or their authorized representative must be established within the Community (manufacturers based outside the EU can only place products on the EU market by designating a sole authorized representative; Regulation 2017/745); Retention—If neither the manufacturer nor the authorized representative is established within the Community, the person placing the product on the market is responsible (Decision 93/465/EEC)—In summary, compilation involves six aspects: preparation by the manufacturer; retention by the authorized representative; the authorized representative does not draft the document; the compiler is established in the EU; compliance with Annex VII requirements;
and the designation of an authorized representative by non-EU manufacturers.
III. Document Content
What does the document content entail?
Based on CE technical documentation practices, the content should be reviewed across these areas: **Fundamentals**—the technical file must contain comprehensive risk analysis and assessment (including, at a minimum: manufacturer/authorized representative details, brief product description, product identification such as serial numbers, names/addresses of design and manufacturing facilities, details of any Notified Bodies involved in conformity assessment, conformity assessment procedures); **Risks**—manufacturers must identify and assess all risks (identifying potential hazards to users, property, or the environment; determining applicable essential requirements—i.e., safety, health, and environmental mandates protecting public interests under relevant EU rules; describing risk mitigation steps such as the application of harmonized standards; documenting the risk analysis within the technical file); **Machinery**—machinery safety processes (conducting risk assessments to identify applicable health and safety requirements; incorporating assessment findings into design and construction; defining usage limits; identifying potential hazards; assessing risks of serious injury or damage and implementing countermeasures; ensuring compliance with Annex I essential health and safety requirements; providing technical documentation confirming compliance); **Identification**—machine description and identification (including generic name, function, model, type, serial number, and trade name); **Declaration**—a clear statement declaring that the machine meets all relevant provisions of the directive (and, where applicable, compliance with other directives); **Marking**—all machines must bear clear, permanent markings indicating minimum information (manufacturer name and address, CE mark, series or type designation, serial number if applicable, year of construction); **Language**—technical documentation must be prepared in one or more official Community languages (with specific provisions for instruction manuals, Annex VII). In summary, the content covers six key aspects: risk analysis, product description and identification, facility details, Notified Body information, declaration of conformity, and clear, permanent marking—ensuring a complete set of required information.
IV.
Retention Period
What to consider regarding the retention period.
Regarding CE documentation retention practices, the requirements are as follows: 10 years—Manufacturers must retain technical documentation and the EU Declaration of Conformity for market surveillance authorities for at least 10 years (after the machinery or related product is placed on the market; Regulation 2023/1230); Authorized Representatives—Authorized representatives must retain technical documentation and the EU Declaration of Conformity (or the EU Declaration of Incorporation for partly completed machinery) for at least 10 years (after the product is placed on the market; compliance information provided in paper or digital format; Regulation 2023/1230); Low Voltage—Manufacturers must retain the technical documentation described in Annex III and the EU Declaration of Conformity for 10 years (after the electrical equipment is placed on the market; Low Voltage Directive 2014/35/EU); EMC—Authorized representatives must retain the EU Declaration of Conformity and technical documentation for national market surveillance authorities for 10 years (after the equipment is placed on the market; Directive 2014/30/EMC); RoHS—Authorized representatives must retain the EU Declaration of Conformity and technical documentation for 10 years (after the EEE is placed on the market; Directive 2011/65/EU); PPE—Authorized representatives must retain the EU Declaration of Conformity and technical documentation for 10 years (after the PPE is placed on the market; Regulation 2016/425); Responsibility—Manufacturers or their authorized representatives established within the Community must retain documentation for at least 10 years for inspection by national authorities (if not established within the Community, the party placing the product on the market bears responsibility; Decision 93/465/EEC)—Summary of the six retention requirements: Manufacturers (10 years), Authorized Representatives (10 years), LVD (10 years), EMC (10 years), PPE (10 years), and the party placing the product on the market (as the ultimate responsible party);
ensure all six requirements are met.
V. Providing Cooperation
What is involved in providing cooperation?
Regarding CE documentation practices, consider these six aspects: **Availability**—technical documentation must be provided upon request (physical copies are not required to be permanently available, but must be producible when asked for; Directive 2006/42/EC); **Evidence**—documentation must demonstrate conformity with the essential requirements of harmonized EU regulations (supporting and substantiating the EU Declaration of Conformity; required for affixing the CE mark); **Provision**—all necessary information and documentation (in paper or digital format proving product conformity) must be provided upon the reasonable request of competent national authorities (Regulation 2023/1230); **Cooperation**—the authorized representative must cooperate with competent national authorities (regarding actions taken to ensure EEE compliance with the directive; Directive 2011/65/EU); **Market Access**—manufacturers must make technical documentation and the EU Declaration of Conformity available to market surveillance authorities (for at least 10 years after placing the product on the market; Regulation 2023/1230); **Inspection**—competent authorities may request proof (conformity assessment; EUR-Lex); **Responsibility**—full accountability for verification (manufacturer bears sole responsibility; European Commission).
These six perspectives—availability upon request, substantiation of the EU Declaration, paper/digital formats, cooperation with authorities, accessibility for market surveillance, and sole responsibility—ensure a reliable approach.
Conclusion
Regarding who provides the CE technical documentation for non-standard assembly lines, the conclusion is defined by five dimensions: the responsible entity, compilation, content, retention, and provision.
Responsibility—The manufacturer bears full responsibility (drafting the EU Declaration of Conformity, affixing the CE mark, verifying compliance with all relevant regulations, undergoing Notified Body inspections where necessary, and adhering to Regulation (EU) 2023/1230 which replaces Directive 2006/42/EC); Preparation—The manufacturer or their EU-based authorized representative prepares the technical documentation (the authorized representative is not responsible for drafting but is obligated to retain and provide the documents; non-EU manufacturers must appoint a sole authorized representative; if neither the manufacturer nor the authorized representative is based in the EU, the party placing the product on the market assumes responsibility); Content—The technical documentation includes a risk analysis (identifying hazards, determining essential requirements, and describing measures to eliminate or reduce risks), along with the name and address of the manufacturer’s authorized representative, a brief product description and serial number, details of design and manufacturing facilities, Notified Body information, conformity assessment procedures, machine identification details, and a clear declaration of conformity with the directive; Retention—At least 10 years after the product is placed on the market (applies to manufacturers, authorized representatives, and directives such as LVD, EMC, RoHS, and PPE; the party placing the product on the market bears ultimate liability); Provision—Must be provided upon request in paper or digital format, supplied to market surveillance authorities upon reasonable request, and supported by cooperation with competent authorities;
the CE mark is valid only when the technical documentation supports and substantiates the EU Declaration of Conformity.
In summary, regarding CE technical documentation: the manufacturer holds full responsibility (though an authorized representative may manage the files), the content is underpinned by a risk analysis, and records must be kept for 10 years and made available upon request—clear these four hurdles, and CE compliance is assured.
