What Is the Machinery Regulation?

Every business that manufactures machinery, imports it, or sets up a new production line in its factory sooner or later encounters the concept of the "Machinery Safety Regulation." This regulation is the core piece of legislation through which Turkey has aligned the EU's Machinery Directive with its own legal framework, and it rests on one of the most comprehensive and technically detailed directives in CE legislation. In this article we cover what the Machinery Safety Regulation is, which products it covers, its essential requirements, and the changes that the soon-to-apply new Machinery Regulation will bring.

What Is the Machinery Safety Regulation, and What Legislation Is It Based On?

The Machinery Safety Regulation is the national regulation in force in Turkey that largely mirrors, one-to-one, the provisions of the EU's Machinery Directive 2006/42/EC. Under Turkey's obligations within the Customs Union with the EU, core product-safety directives of this kind have been aligned with Turkish legislation and made applicable in the domestic market as well. This is why a machine manufacturer is subject to this regulation's requirements not only when exporting to the EU, but even when selling exclusively in the Turkish domestic market.

The core purpose of the regulation is to guarantee a minimum level of safety at the design and manufacturing stage of machinery, thereby protecting the life and property of both machine operators and any third parties in the vicinity of the machine. To this end, the regulation requires machinery to be subject to CE marking, requires a technical file to be prepared, requires a risk analysis to be carried out, and requires an EU Declaration of Conformity to be issued. See our article What Is CE Certification? for the general framework of the CE process.

Products Covered by the Regulation's Scope

The scope of the Machinery Safety Regulation is much broader than the everyday meaning of "machine." The main product categories within scope are: "machinery" — assemblies of linked parts, at least one of which moves, driven by a power source, designed to perform a specific function; "partly completed machinery" — items that cannot function on their own and are manufactured to be built into another machine; "interchangeable equipment" fitted by the user to change a machine's function; "safety components" carrying a safety function and placed on the market separately (such as safety relays, light curtains); "lifting accessories" used for load lifting; certain chains, ropes and belts; and "removable mechanical transmission devices" used in mechanical power transmission (such as drive shafts). Correctly determining which of these categories a manufacturer's or importer's product falls into is critical for correctly determining the applicable procedure.

Essential Health and Safety Requirements (EHSR)

At the center of the regulation is the list known by its English abbreviation, EHSR (Essential Health and Safety Requirements). This list covers numerous subtopics, including protection against mechanical hazards, electrical installation safety, safe design of control systems, ergonomics, noise and vibration limits, fire and explosion risks, maintenance safety, and the content of instructions for use. Every machine must meet the EHSR items relevant to its own nature; determining which EHSR items apply to a given machine is also part of the risk analysis process. See our article How Is Risk Analysis Done? for more detail on how risk analysis is carried out.

Self-Declaration or Notified Body?

For the vast majority of machinery under the Machinery Safety Regulation, the manufacturer can complete CE marking through self-declaration (internal production control) — signing the declaration of conformity based on its own technical assessment, without needing the approval of an independent body. However, for certain high-risk machinery categories explicitly listed in the regulation's relevant annex (for example, certain woodworking and metalworking machines, presses, injection molding machines, some lifting and material-handling equipment), the involvement of an independent notified body is mandatory. Getting this distinction right is one of the most critical decisions at the start of the process; see our article What Is a Notified Body? to learn under which circumstances a notified body is needed.

The Special Procedure for Partly Completed Machinery

One frequently confused aspect of the regulation is the concept of "partly completed machinery." This category covers intermediate products — such as a motor drive unit to be mounted on a production line — that cannot perform a specific application on their own but are designed to be integrated into another machine or piece of equipment. Such products do not go through full CE marking; instead, the manufacturer issues a "declaration of incorporation" and prepares a set of instructions that clearly states the conditions for integration into the final machine, which essential requirements are met, and which remain the responsibility of the final assembler. The company that assembles the final product is responsible for ensuring the whole assembly's conformity with the regulation.

Transition to the New Machinery Regulation (EU) 2023/1230

An important development at the EU level is that the current Machinery Directive 2006/42/EC will be progressively replaced by Machinery Regulation (EU) 2023/1230, applicable from 20 January 2027. The move from directive to regulation matters in terms of legal nature: a directive provides a framework that member states must transpose into their own national legislation, while a regulation is directly and identically applicable across member states. The new regulation also updates the list of high-risk machinery, places greater emphasis on risks arising from artificial intelligence and software and on cybersecurity elements, and, under certain conditions, allows digital format and electronic user manuals. Manufacturers and importers operating in the machinery sector are advised to start planning for the transition timeline and its impact on their product portfolio now.

The Concrete Obligations of the Manufacturer and Importer

The manufacturer of a machine under the Machinery Safety Regulation carries specific concrete obligations from the very start of the process: carrying out the risk analysis at the design stage, ensuring conformity with EHSR requirements, building the technical file and keeping it for the period required by law, signing the EU Declaration of Conformity, correctly affixing the CE marking, and providing a complete user manual together with the machine. These obligations continue after the machine is placed on the market as well; the manufacturer is obligated to monitor any non-conformity complaints regarding machines it has placed on the market and to initiate corrective action where necessary.

Specific responsibilities also apply to importer and exporter companies bringing machinery from outside the EU into Turkey, or exporting from Turkey to the EU. The importer must verify that the machine it places on the market carries the CE marking, that the technical file and declaration of conformity have been prepared by the manufacturer, must state its own contact details on the machine or accompanying documents, and must ensure that transport and storage conditions do not compromise the machine's conformity. Where the manufacturer is established outside the EU, appointing an authorized representative within the EU is often chosen as a practical solution, easing access to the technical file and communication with authorities. Clarifying this division of responsibility contractually as well prevents ambiguity about who bears which obligation among the parties in the supply chain in the event of a non-conformity.

Relevant Directives and Standards

The EU-level equivalent of the Machinery Safety Regulation is the Machinery Directive 2006/42/EC; this directive will be progressively replaced by Machinery Regulation (EU) 2023/1230 from 20 January 2027. Where a machine has electrical components, the Low Voltage Directive 2014/35/EU usually applies; for machines with wireless control or communication capability, the Radio Equipment Directive 2014/53/EU must also be assessed. ISO 12100 is the core reference for the risk assessment methodology; in addition, type-C harmonized standards prepared for many machine types define, more concretely, the hazards and requirements specific to that machine. The conformity assessment models defined by the general framework of Regulation (EC) No 765/2008 and Decision No 768/2008/EC are applied with the same logic in the machinery sector.

Step by Step

1. Determine which category under the regulation (machinery, partly completed machinery, safety component, etc.) your product falls into.
2. Identify which EHSR (essential health and safety requirements) items apply to the product.
3. Carry out a comprehensive risk analysis in line with ISO 12100 and the relevant type-C standards.
4. Check whether the product appears on the high-risk machinery list to clarify whether self-declaration or notified body involvement is required.
5. Build the technical file, including design drawings, the risk analysis, applied standards and test results.
6. Prepare a complete user manual suited to the machine's language and target market.
7. Sign the EU Declaration of Conformity (or, for partly completed machinery, the declaration of incorporation).
8. Affix the CE marking to the machine's rating plate at the correct size and position.
9. Track the upcoming Machinery Regulation transition and plan your product portfolio accordingly.

Most Common Mistakes

• Assuming the regulation doesn't apply simply because the product isn't exported to the EU.
• Confusing partly completed machinery with a machine requiring full CE marking.
• Proceeding with self-declaration without checking the high-risk machinery list.
• Treating risk analysis as a superficial checklist instead of a systematic ISO 12100 process.
• Preparing the user manual without translating it into the target market's language, or with incomplete content.
• Overlooking the additional directives (LVD, RED) required for the machine's electrical or wireless components.
• Not preparing now for the changes the new Machinery Regulation will bring.

Frequently Asked Questions

The Competitive Dimension for Domestic Machinery Manufacturers

Although many domestic manufacturers see compliance with the Machinery Safety Regulation purely as a legal burden, it is in fact an opportunity that can be turned into a competitive advantage. Corporate buyers involved in public tenders, large industrial facilities and international supply chains increasingly scrutinize CE conformity — and the quality of the accompanying technical file — when selecting suppliers. A manufacturer with a complete technical file, a systematic risk analysis and a correctly marked product builds trust with both large domestic buyers and export markets, and enters tender/quote processes better prepared than its competitors. This is why addressing compliance with the Machinery Safety Regulation early and systematically doesn't just reduce audit risk — it also expands commercial opportunities.

Conclusion

The Machinery Safety Regulation is one of the most comprehensive and technically detailed pieces of CE legislation for businesses that manufacture and import machinery. Correctly determining scope, fully meeting EHSR requirements, systematically carrying out risk analysis, and choosing the right conformity assessment procedure (self-declaration or notified body) are all critical steps for the process to run smoothly. Tracking the changes the new Machinery Regulation will bring when it takes full effect in 2027, starting now, will also give manufacturers doing long-term product planning a significant advantage.