Placing a machine on the market is not just about affixing the CE marking to the product. Behind that marking lies a series of legal obligations the manufacturer carries from the product's design all the way through its service life on the market. Many companies think these responsibilities end once the CE marking is applied — but that's not the reality. In this article we examine in detail who a machine manufacturer is, which obligations it carries, where the importer's and distributor's responsibilities begin and end, and which duties must continue after placement on the market.
Who Is a "Manufacturer" Under the Legislation?
Under the economic operator definitions introduced by the New Legislative Framework, a "manufacturer" is any natural or legal person who designs or manufactures a machine, or has it manufactured, and markets it under their own name or trademark. This definition covers not just companies that directly manufacture, but also certain other situations: for example, a company that sells another company's manufactured machine under its own brand, makes a substantial modification affecting the safety performance of an existing machine, or reconfigures a machine for its own intended use can also fall under manufacturer status in the eyes of the legislation, and may be required to assume all manufacturer obligations. This is why the defense "we just do the assembly for an OEM manufacturer, we're not the manufacturer" can lose its validity once a substantial modification is involved.
Core Manufacturer Obligations
A machine manufacturer's core obligations under CE legislation can be summarized as: correctly determining the directives and regulations applied to the product, carrying out a comprehensive risk analysis, applying the relevant harmonized standards or proving an equivalent level of safety where deviating from a standard, building a complete technical file, having the required laboratory tests carried out, preparing and signing the EU Declaration of Conformity, correctly affixing the CE marking to the product, and keeping the technical file and declaration accessible for the period required by law (usually 10 years). None of these steps is sufficient on its own — the process is expected to be carried out holistically and consistently. See our detailed guide, How to Prepare a Technical File?, for how the technical file is prepared.
The User Manual and Information Obligation
The manufacturer is obligated to prepare adequate information on the machine's safe installation, use, maintenance and decommissioning processes, in the language of the target market (in Turkish, for machines placed on the market in Turkey). If this manual is incomplete or inadequate, even a technically safely designed machine does not remove the manufacturer's responsibility, because the legislation treats user information as an integral part of the essential requirements. The manual's content must cover the machine's technical characteristics, intended use, unforeseeable-misuse risks, residual risks, and emergency procedures.
The Importer's and Distributor's Responsibilities
Although the manufacturer bears primary responsibility, other economic operators in the supply chain also have their own specific obligations. The importer is obligated to ensure the conformity assessment of the product it places on the EU or Turkish market was correctly carried out by the manufacturer, that the technical file and declaration of conformity exist, to add its own name and contact details to the product or packaging, and to make sure storage/transport conditions do not compromise conformity. The distributor, as it moves the product forward on the market, must check with reasonable care that the CE marking, the required documents and a Turkish manual exist, must not offer the product for sale if it notices any non-conformity, and must notify the relevant party of the situation. While these operators' responsibilities are more limited than the manufacturer's, none of them can be entirely exempted from responsibility by saying "we're just an intermediary."
The Role of the Authorized Representative
Manufacturers established outside the EU can delegate certain tasks (for example, keeping the technical file accessible, communicating with authorities) to an authorized representative established within the EU, through a written mandate. However, substantive responsibilities such as risk analysis, preparing the technical file and ensuring conformity remain with the manufacturer; the authorized representative serves only as an administrative and communication bridge.
Obligations After Placing on the Market
The manufacturer's responsibility continues after the product is placed on the market. The manufacturer is obligated to track complaints and non-conformity reports from users or market surveillance authorities, initiate corrective action (recall if necessary) if a serious risk is identified with the product, systematically keep product records (serial number, manufacturing date, shipment information), and respond to competent authorities' requests within a reasonable time and in cooperation. Neglecting these obligations can lead to serious administrative sanctions and reputational damage during inspections; see our article What Do CE Audits Look At? for what is examined during an inspection.
The Record-Keeping and Traceability Obligation
An important but often neglected dimension of manufacturer responsibilities is the traceability obligation. The manufacturer must have a record system able to track which serial or batch number, on which date, and with which components each machine was manufactured. These records make it possible to quickly identify which products are affected if a non-conformity is found, to carry out a targeted recall if needed, and to present concrete evidence to a market surveillance authority. Manufacturers with weak traceability systems can be forced to halt an entire product range even for a minor non-conformity, magnifying both cost and reputational damage.
Product Liability and the Insurance Dimension
Beyond the administrative obligations under CE legislation, the manufacturer also carries product liability under general law — meaning it can be held responsible for harm caused to third parties by a defective product design or manufacture. This risk is reduced by correctly executed CE marking but not entirely eliminated, because the CE marking is an administrative declaration of conformity, not on its own an absolute legal defense in a potential dispute. This is why many manufacturers also financially manage this risk by taking out product liability insurance. It's advisable to regularly review whether the insurance policy's coverage matches the risk profile of the machines being manufactured.
Contractual Division of Responsibility Across the Supply Chain
When more than one party (a subcontractor, a component supplier, a systems integrator) is involved in manufacturing a machine, the manufacturer definition in the legislation and the commercial contracts the parties make with each other can sometimes provide for different distributions of responsibility. However, the critical point here is this: private-law contracts can regulate the parties' obligations toward each other, but they cannot remove the public-law manufacturer responsibility set out in the legislation. In other words, even if a company thinks it has contractually transferred responsibility to another party, if it falls under the definition of manufacturer in the eyes of the legislation, it remains the primary party accountable to the market surveillance authority. This is why it's very important for supply chain contracts to be structured consistently with the responsibility distribution set out in the legislation.
Spreading Responsibility Awareness Within the Organization
Assuming manufacturer obligations are only a matter for the quality or engineering department creates a serious weakness in practice. In reality, compliance with CE legislation requires the purchasing department to request conformity documents when selecting a component supplier, the sales and marketing department to promote the product only in markets where CE scope has been clarified, the R&D department to assess design changes for their legislative impact, and senior management to allocate sufficient resources to these processes. Concentrating responsibility awareness in a single department causes non-conformity risks to go unnoticed at the points where inter-departmental information flow breaks down. This is why treating manufacturer obligations as an organization-wide awareness issue is decisive for the sustainability of the process.
Relevant Directives and Standards
The manufacturer's general obligations, independent of product group, are defined in the two core texts of the New Legislative Framework: Regulation (EC) No 765/2008, which sets out the general rules of market surveillance and the CE marking (the market surveillance provisions of this regulation have been updated by Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products), and Decision No 768/2008/EC, which standardizes the conformity assessment modules. For machine manufacturers, in addition to this general framework, the Machinery Directive 2006/42/EC (and Machinery Regulation (EU) 2023/1230, applicable progressively from 20 January 2027) applies directly. If the product carries electrical, wireless-communication or electromagnetic-interaction elements, the Low Voltage Directive (2014/35/EU) and the Radio Equipment Directive (2014/53/EU) also fall within the manufacturer's scope of obligation.
| Economic Operator | Core Area of Responsibility |
|---|---|
| Manufacturer | Design, risk analysis, technical file, declaration of conformity, CE marking, record-keeping, post-market tracking |
| Authorized representative | Administrative tasks delegated by the manufacturer, communication with authorities |
| Importer | Verifying conformity, adding its own information, preserving transport/storage conditions |
| Distributor | Reasonable-care check that documents and marking exist, not offering non-conforming products for sale |
Step by Step
- Clarify which economic operator status (manufacturer, importer, distributor) your company holds under the legislation.
- If you hold manufacturer status, fully determine all directives and regulations that apply to the product.
- Carry out the risk analysis and build the foundation of the technical file.
- Prepare the user manual in the target market's language, with the content elements the legislation requires.
- Prepare the EU Declaration of Conformity and have it signed by an authorized signatory.
- Archive the technical file, declaration and manual, accessible for the required period.
- Set up an internal procedure for complaint tracking and corrective action processes after placement on the market.
- Make sure importers and distributors in your supply chain are aware of their own obligations.
Most Common Mistakes
- Ignoring the manufacturer responsibility that arises after a substantial modification by saying "we just do the assembly, we're not the manufacturer."
- Not preparing the user manual in the target market's language, or publishing it with incomplete content.
- Not setting up any internal process for complaint and non-conformity tracking after placement on the market.
- Deleting the technical file or making it inaccessible before the required period has elapsed.
- Confusing tasks that can be delegated to the authorized representative with substantive responsibilities that cannot.
- Accepting the manufacturer's documents without ever questioning them while taking on the importer/distributor role.
- Assuming the manufacturer's responsibility ends entirely once the product changes hands.
Frequently Asked Questions
Does the definition of a machine manufacturer cover only the manufacturing company?
No. The legislation also treats companies that place a product on the market under their own brand, make a substantial modification to an existing machine, or relabel a machine under their own name as manufacturers; these companies also assume all manufacturer obligations.
For how many years should the manufacturer keep the technical file?
In general practice, the technical file and the EU Declaration of Conformity should be kept accessible and presentable for at least 10 years from the date the machine is placed on the market.
Does the importer have different responsibilities from the manufacturer?
Yes. The importer is obligated to ensure the manufacturer has met its relevant obligations, verify that the technical file and declaration of conformity exist, and add its own name/contact details to the product or packaging; however, primary responsibility rests with the manufacturer.
What is the distributor's role in the placing-on-the-market process?
As it moves the product forward in the supply chain, the distributor is obligated to check with reasonable care whether the CE marking, the required documents and a Turkish user manual exist; if it notices a non-conformity, it should not offer the product for sale and should inform the competent authority.
Must the manufacturer be established within the EU?
No, but manufacturers established outside the EU can generally appoint an authorized representative within the EU and delegate certain tasks to that representative, such as signing the declaration of conformity and keeping the technical file accessible.
Which obligations does the manufacturer continue to carry after placing the product on the market?
The manufacturer is obligated to track complaints and non-conformity reports, initiate corrective action where required, keep product records up to date, and respond to market surveillance authorities' requests within a reasonable time.
Who does a subsequent modification to the machine create new responsibility for?
A party that makes a substantial modification to the machine affecting the original design's safety performance can become a new manufacturer under the legislation, and may become obligated to carry out a new conformity assessment under its own name.
Is the manufacturer obligated to recall a non-conforming product?
If the product is found to pose a serious risk, the manufacturer is obligated to carry out corrective action in cooperation with the market surveillance authority, and if necessary, to recall the product or withdraw it from the market.
Does the manufacturer's responsibility continue after the product is sold to another company?
Yes, responsibility for the accuracy of the declaration of conformity and the technical file remains with the manufacturer; the product changing hands does not remove this responsibility. However, new responsibilities can arise if the end user makes a substantial modification to the product.
Are small-scale manufacturers subject to the same obligations?
Yes, the legislation does not differentiate by business size; small and medium-sized manufacturers are subject to the same technical file, risk analysis, declaration of conformity and record-keeping obligations.
Is the manufacturer responsible for special-purpose machines sold for its own employees?
Yes, a machine being manufactured for internal use rather than commercial purposes generally subjects the manufacturer to the same core obligations; exceptions are limited and must be assessed by product group.
Is the manufacturer required to take out product liability insurance?
CE legislation does not directly impose an insurance requirement; however, because it provides financial protection against legal claims that could arise from a product defect, product liability insurance is a practically recommended risk-management tool for many manufacturers.
Are manufacturer obligations solely the responsibility of the quality department?
No, in practice the decisions of many departments — purchasing, R&D, sales and senior management — directly affect CE compliance; concentrating responsibility awareness in a single department alone can allow risks to go unnoticed during inspections.
All of a manufacturer's obligations essentially correspond to different steps of a CE certification process from start to finish. If you'd like to see how these obligations are met at each stage of the process, see our article The CE Certification Process Step by Step.
Conclusion
A machine manufacturer's legal responsibilities don't end the moment the CE marking is affixed to the product — they require ongoing management stretching from design through post-market tracking. Clearly defining these responsibilities both reduces legal risk and helps other parties in the supply chain (importer, distributor, integrator) correctly understand their own role. Points where the distribution of responsibility is unclear are usually the areas that create the most problems during inspections and disputes. This is why it's important for companies to clearly define their own role in the eyes of the legislation and build a documentation and record-keeping culture suited to that role — this significantly reduces both short-term inspection risks and long-term legal risks. Responsibility management is not a one-off compliance exercise — it's a discipline that must be maintained throughout the product's entire lifecycle.
If you're not sure where your responsibilities start and end, let's assess it together. See our CE consultancy service for more details.
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