Introduction: The importance of the new EU Regulation for Ukrainian industry

From January 20, 2027, the new Regulation (EC) 2023/1230 on machinery comes into force, which will replace the current Directive 2006/42/EC. This document, known as the "Machinery Regulation", establishes updated and strengthened requirements for the safety of machinery and related equipment placed on the European Union market. For Ukrainian industrial enterprises that seek to integrate into the European market or already use imported equipment, understanding and fulfilling these requirements is critically important. This is not only a question of access to markets, but also of ensuring smooth operation, safety of personnel and minimization of production risks.

As Chief Engineer of UNITEC-D GmbH, I emphasize that the adaptation of maintenance, repair and operation (MRO) processes to new standards is a strategic necessity. Failure to comply can result in significant financial losses, equipment downtime and legal liability. This material is intended to provide Ukrainian engineers and production managers with a practical guide to preparing for new regulatory requirements.

Scope and compliance

Regulation (EC) 2023/1230 applies to a wide range of machinery, interchangeable equipment, interchangeable tools, protective devices, safety components, lifting devices, chains, ropes, belts, removable mechanical transmission devices, as well as partially completed machines. It applies to both manufacturers and importers, distributors and end users of machines who modernize or modify equipment. For Ukrainian companies, this means that any equipment supplied from the EU or intended for export to the EU must meet the new requirements.

Particular attention should be paid to machines that have been modified after commissioning. If the modification significantly changes the functionality or safety of the machine, it may be considered as a new machine and require re-assessment of conformity under the Regulation. This also applies to equipment that was manufactured in Ukraine for the domestic market, but uses components subject to EU regulation, or is planned for export.

Compliance with the requirements of the Regulation is confirmed by the CE marking. For the domestic market of Ukraine, the UkrSEPRO certificate is also important, which confirms compliance with national standards, often harmonized with European ones, such as DSTU EN ISO 12100:2016 (Machine safety. General principles of design. Risk assessment and risk reduction).

Key requirements of the new Regulation

Regulation (EU) 2023/1230 introduces a number of important changes and clarifications that must be taken into account. The main ones include:

• Strengthened requirements for cyber security: For the first time, the Regulation clearly includes requirements for protecting machines from external cyber attacks that could affect their safe operation. This means the need to integrate cybersecurity measures at the design and implementation stage.
• Digital documentation: It is allowed to provide instructions and declarations of conformity in a digital format, which simplifies access and updating of information. However, upon user request, a paper version shall be available.
• Definition of "substantial modification": Clarified what is considered a "substantial modification" that requires a new conformity assessment. This is an important aspect for MRO, as equipment upgrades often take place on production sites.
• New definitions of security components: The list of components classified as security components requiring a mandatory conformity assessment has been expanded.
• The role of artificial intelligence: Considered the risks associated with the use of artificial intelligence systems in machines, especially in safety systems.

Table of main obligations and terms

Impact on MRO operations

The new Regulation significantly affects all aspects of maintenance, repair and operation of industrial equipment:

1. Changes in maintenance: Preventive maintenance (PM) and condition maintenance (CBM) programs should be reviewed. Audits of cybersecurity systems and updates to security-affecting software must be integrated. For example, for control systems with safety functions (Safety PLCs) with performance level (PL) "d" or "e" according to EN ISO 13849-1:2015, regular functional checks and validation become even more critical.
2. Changes in procurement: Procurement departments must ensure that all spare parts and components, especially those classified as safety components, are supplied with appropriate declarations of conformity of CE and, if necessary, UkrSEPRO. UNITEC-D GmbH, as a global supplier of MRO components, guarantees compliance of its products with these standards.
3. Changes in documentation: All technical documentation, including operation manuals, schematics, test reports and service logs, must be updated to meet the new requirements. The transition to digital formats requires the implementation of electronic document management and version control systems.
4. Repair and Upgrade Risk Assessment: Any major repair or upgrade that may affect the safety of the machine now requires a new risk assessment and potentially re-certification. For example, changing a hydraulic system with a working pressure of 250 bar to a system with a working pressure of 320 bar will require all components to be tested for compliance with higher loads and new safety standards.

Requirements for components and spare parts

Regulation (EU) 2023/1230 pays special attention to safety components. These are not only the obvious elements, such as emergency switches or light barriers, but also other parts, the failure of which can lead to danger. They include:

• Elements of safety-related control systems: Safety relays, safety controllers (Safety PLCs), position sensors, light curtains (eg type 4 according to EN ISO 13849-1), emergency stop buttons (EN ISO 13850). They must have an appropriate performance level (PL) or safety integrity level (SIL).
• Hydraulic and pneumatic components: Safety valves, hydraulic hoses and tubes (e.g. according to EN 853, EN 857) working under pressure up to 400 bar, pneumatic cylinders and valves. These components must be certified to comply with the Pressure Equipment Directive (PED 2014/68/EU), if applicable, and have declarations of conformity.
• Mechanical components: Couplings, brake systems, reducers, load-bearing elements of structures affecting safety. For example, bearings for high-precision spindles must meet the accuracy class ISO 492 (eg P4/ABEC7) to ensure stable and safe operation.
• Electrical components: Protective switches, contactors, overload relays complying with EN 60204-1:2018 (Electrical equipment of machines).
• Sensors and encoders: Especially those used in feedback systems to control position or speed, which can affect safety. They must have appropriate functional safety certificates.

When purchasing these components, it is critical to require full technical documentation and certificates (CE, UkrSEPRO) from suppliers. UNITEC-D GmbH offers a wide range of components from leading European manufacturers that fully meet these requirements, ensuring the reliability and safety of your equipment.

Compliance Checklist for MRO Managers

To ensure compliance with the new Regulation (EU) 2023/1230, MRO managers must conduct a comprehensive assessment and implement the following measures:

1. Check all existing machines for declarations of conformity and CE marking.
2. Identify machines that have been significantly upgraded or modified and assess the need for re-certification.
3. Review and update internal risk assessment procedures to take into account new requirements, including cyber security.
4. Develop and implement cybersecurity testing protocols for machine control systems.
5. Update procurement standards to include requirements for CE and UkrSEPRO certificates for all critical components and spare parts.
6. Create a register of all security components used in the enterprise, indicating their certification and service life.
7. Review and update preventive maintenance programs to include functional security and cyber security checks.
8. Ensure that all repairs affecting safety are carried out using certified spare parts and in accordance with approved procedures.
9. Update the operation and maintenance instructions, ensuring their compliance with the new Regulation and availability (including in digital format).
10. Organize training for MRO technical staff on the new requirements of the Regulation and relevant harmonized standards (eg EN ISO 13849, EN ISO 12100).
11. Implement a change management system for any equipment modifications that ensures proper risk assessment and documentation.
12. Check the availability and validity of calibration certificates for measuring devices used to check the safety of machines.
13. Develop an action plan in the event of a non-conformity or failure of a safety component.
14. Ensure proper storage of technical documentation and compliance protocols throughout the life cycle of the machine.
15. Regularly conduct internal audits of compliance of MRO processes and equipment with the requirements of the Regulation.
16. Check whether MRO service providers also comply with the new requirements when performing work on your equipment.
17. Pay attention to the integration of new technologies (for example, the Internet of Things, AI) and their impact on machine safety and compliance with the Regulation.
18. Implement a life cycle tracking system for safety components that includes installation, maintenance and replacement data.

Typical inconsistency problems

Our experience in auditing industrial enterprises shows that the most common reasons for non-compliance are:

• Insufficient risk assessment: Often, not all potential hazards are considered, especially after modifications or integration of new equipment.
• Missing or outdated documentation: Incomplete or outdated instructions, declarations of conformity, service logs.
• Using non-certified spare parts: Replacing original safety components with cheaper, non-certified counterparts, which compromises functional safety. For example, replacing a certified safety relay (PL d) with a standard industrial relay.
• Incorrect connection or configuration of security systems: Errors in the installation or programming of security devices, which lead to their ineffectiveness.
• Ignoring cyber security: Inadequate protection of control systems against unauthorized access or malware.
• Insufficient staff training: Operators and technicians are not aware of the new requirements or do not know how to properly operate and maintain the equipment, taking into account the increased safety standards.
• Non-conformity after retrofitting: Upgrading of equipment without re-assessment of conformity and proper documentation, which turns it into a "new machine" from the point of view of the Regulation.

Penalties and liability for non-compliance

Non-compliance with the requirements of Regulation (EU) 2023/1230 can have serious consequences for Ukrainian enterprises, especially if they work with the EU market or plan to do so. Sanctions may include:

• Fines: National supervisory authorities in EU countries have the right to impose significant financial fines. Depending on the severity of the violation and national legislation, these fines can reach tens or even hundreds of thousands of euros (for example, in Germany, fines for labor safety violations can reach up to 50,000 euros, and in some cases - much higher).
• Withdrawal of products from the market: An uncertified or unsafe machine may be withdrawn from the EU market, resulting in significant commercial losses.
• Suspension of activity: In case of detection of critical security violations, operation of the equipment may be suspended until all deficiencies are eliminated. This means production downtime and loss of profit.
• Recalls: If non-conforming equipment has already been sold, a recall may be required, resulting in huge costs and reputational damage.
• Insurance premium increases: Insurance companies may increase premiums or deny payments in the event of incidents caused by non-compliance.
• Legal responsibility: In case of industrial accidents caused by non-compliance of machines with safety requirements, the management of the enterprise and responsible persons may bear administrative and even criminal liability.
• Reputational losses: Security incidents or product recalls can cause irreparable damage to a company's reputation, affecting the trust of customers and partners.

Conclusion

The entry into force of Regulation (EU) 2023/1230 on January 20, 2027 is an important milestone for the industrial sector. This requires Ukrainian manufacturing enterprises to take a proactive approach to the implementation of new safety standards, especially in the context of MRO. Process adaptation, staff training and the use of certified components are key to ensuring compliance, minimizing risks and maintaining competitiveness in the international market.

UNITEC-D GmbH is your reliable partner in this transition. We offer a wide range of high-quality, certified components and spare parts that meet the strictest European and international standards, including CE and UkrSEPRO. Our engineers are ready to provide expert support in choosing the right solutions to ensure the safe and efficient operation of your equipment.

Explore our range of certified components and find a solution for your production in the UNITEC-D E-Catalog.

Link

1. Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC and Council Directive 73/361/EEC.
2. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast).
3. EN ISO 12100:2010. Safety of machinery – General principles for design – Risk assessment and risk reduction. (Гармонізований ДСТУ EN ISO 12100:2016).
4. EN ISO 13849-1:2015. Safety of machinery – Safety-related parts of control systems – Part 1: General principles for design.
5. EN 60204-1:2018. Safety of machinery – Electrical equipment of machines – Part 1: General requirements.
6. EN ISO 13850:2015. Safety of machinery – Emergency stop function – Principles for design.
7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast).

Introduction: why this regulation is critical for industrial enterprises of Ukraine

On January 20, 2027, Regulation of the European Parliament and of the Council (EU) 2023/1230 of June 14, 2023, which replaces Directive 2006/42/EC (Machinery Directive), enters into full force. This is not a cosmetic update - it is a complete restructuring of the legal framework for the design, production, introduction into circulation and operation of machinery in the EU.

For Ukrainian industrial enterprises that export products to the EU or use equipment of European origin, this regulation is of direct importance. Compliance with the requirements of 2023/1230 becomes a mandatory condition for the purchase of spare parts, modernization of production lines and capital repairs. Non-compliance means stoppage of supply, loss of contracts and legal liability.

Additionally, in the context of the adaptation of Ukrainian legislation to the EU acquis (according to the Association Agreement, Annex III), the requirements of Regulation 2023/1230 will be implemented in the national DSTU. Businesses that start preparing now will gain a competitive advantage.

Scope and addressees of the regulation

Who should be responsible?

• Manufacturers of machinery and safety components
• Importers of equipment to the EU market
• Distributors of spare parts and components
• Operators of enterprises that carry out significant modification of equipment
• Service organizations performing MRO with the replacement of critical components

What equipment is covered

The regulation applies to:

• Machines and machine assemblies (completely and partially equipped)
• Interchangeable equipment
• Safety components (safety components), including software
• Lifting accessories (lifting accessories)
• Chains, ropes, slings
• Removable mechanical transmission devices

Key change: "substantial modification"

Article 3(16) of Regulation 2023/1230 introduces the legal definition of "substantial modification" for the first time. If the purpose of the machine, its functionality or the type of protective system changes during repair or modernization, the equipment is considered a new product and needs to be re-evaluated for conformity. This directly affects all capital repairs and retrofit projects.

Key requirements: summary table

Impact on MRO operations

Purchase of spare parts

From 20 January 2027, every safety component placed on the EU market must have an EU Declaration of Conformity according to Regulation 2023/1230 (not Directive 2006/42/EC). This means:

• Old declarations of conformity according to 2006/42/EC become invalid for new deliveries
• Stocks of safety components purchased through 2027 can be used, but new purchases require updated documentation
• Suppliers must provide technical documentation in a format that complies with Annex IV of the Regulation

Documentation and traceability

The regulation strengthens traceability requirements. Each economic operator in the supply chain must keep supplier and buyer information for 10 years. For MRO services, this means mandatory maintenance of a register of replaced safety components linked to serial numbers and declarations of conformity.

Technical documentation for modifications

If the repair is classified as a "substantial modification", the person responsible (usually the operator of the plant) becomes the manufacturer within the meaning of the Regulation. This imposes a full range of obligations: risk assessment according to EN ISO 12100:2010, preparation of a technical file, CE marking, declaration of conformity.

Requirements for components

Security components requiring certification

Annex II of Regulation 2023/1230 defines the list of security components. Main categories for MRO:

Requirements for bearings, drives and hydraulics

Although bearings, motors and hydraulic components are not safety components in themselves, they become so if their failure could lead to a dangerous situation. For example:

• The bearing in the lifting mechanism is a safety component according to EN 13001-3-1
• The hydraulic cylinder in the press is a critical element for EN 693:2011
• Frequency converter with STO function (Safe Torque Off) - safety component according to EN 61800-5-2

In such cases, documentation from the manufacturer confirming the suitability of the component for use in the safety function is required, indicating the achieved PL (Performance Level) or SIL (Safety Integrity Level).

Compliance Checklist for Service Managers

Practical checklist for preparing for January 20, 2027:

1. Carry out an inventory of all machinery with valid CE marking according to Directive 2006/42/EC
2. Identify equipment falling under Annex I (high risk) of Regulation 2023/1230
3. Check the availability and relevance of EU Declarations of Conformity for all safety components in the warehouse
4. Classify planned repairs: standard maintenance vs. significant modification
5. Develop criteria for determining "substantial modification" for typical repair operations of the enterprise
6. Update procurement specifications: require suppliers to declare 2023/1230 (not 2006/42/EC) for supplies after 20/01/2027
7. Check the availability of digital operating instructions for equipment where the manufacturer has switched to an electronic format
8. Assess the cyber security of machines with a network connection (requirements §1.1.9 of Appendix III)
9. Check the compliance of safety systems with the requirements of EN ISO 13849-1:2023 (updated version)
10. Ensure the traceability of the supply chain of spare parts (10 years of data storage)
11. Educate MRO personnel on new documentation requirements when replacing safety components
12. Update change management procedures (MOC — Management of Change) taking into account the definition of a significant modification
13. Check insurance policies: do they cover liability for non-compliance with the new Regulation
14. Identify machines with AI/ML components and check their classification under the AI Act (Regulation 2024/1689)
15. Create a register of notified bodies for re-certification in case of significant modifications
16. Review contracts with service organizations: who is responsible for compliance after repair
17. Plan the budget for re-certification of equipment subject to significant modification in 2027-2028.
18. Check the CE marking on stock: components without a valid declaration cannot be used as a replacement for safety components
19. Establish a procedure for verifying suppliers: do they have updated certificates and declarations
20. Conduct a gap analysis between the current state and the requirements of Regulation 2023/1230 with the determination of the deadlines for eliminating non-conformities

Typical inconsistencies detected by auditors

The most frequent violations

• No updated Declaration of Conformity. Safety components are installed, but the declaration refers to Directive 2006/42/EC instead of Regulation 2023/1230. Fine: from €10,000 per piece of equipment (depends on the EU member state).
• Substantial modification without re-certification. The company replaced the press management system, added new functions - but did not conduct a conformity assessment. The equipment is legally ineligible to operate.
• No cybersecurity assessment. The machine is connected to the network, has remote control, but no cybersecurity threat analysis has been performed. Violation of §1.1.9 of Appendix III.
• Use of non-certified safety components. The safety relay is replaced with a normal relay "because it fits by the contacts". PL level reduced from PL e to unspecified — violation of EN ISO 13849-1.
• Lack of traceability. It is not possible to establish who supplied the component, when it was installed, and what its declaration of conformity is.
• Incomplete technical documentation. The operating instructions do not contain information about residual risks or contain only one language (without the language of the country of operation).

Penalties and liability

Financial consequences

Regulation 2023/1230 (Article 50) obliges EU member states to establish "effective, proportionate and dissuasive" sanctions. Specific amounts are determined by national legislation. Approximate framework:

Insurance liability

A critical aspect: in the event of an accident at work, the insurance company checks the compliance of the equipment with current regulations. If it is established that the car was operated after significant modification without re-certification under 2023/1230, the insurer has grounds to refuse payment. This applies to both third-party liability insurance and property insurance.

Criminal liability

In case of injury or death of an employee due to inappropriate equipment, the following are responsible:

• Technical director / chief engineer — for commissioning the equipment
• Maintenance manager — for carrying out a significant modification without due process
• Occupational health and safety specialist — for failure to identify the risk

Punishment: from a fine to imprisonment for a term of up to 5 years (depending on the jurisdiction and the severity of the consequences).

For Ukrainian exporting enterprises

Products supplied to the EU market after January 20, 2027 must comply with Regulation 2023/1230. Inconsistency means:

• Delay at EU customs
• Return of the lot at the expense of the sender
• Entry into the RAPEX database (rapid alert system for dangerous products)
• Loss of contracts and reputational damage

Preparing for Compliance: Practical Steps

Timeline

2025 Q1-Q2: Gap analysis, equipment inventory, risk classification.

2025 Q3-Q4: Update procurement procedures, staff training, supplier audit.

2026 Q1-Q2: Updating technical documentation, carrying out conformity assessments for planned modifications.

2026 Q3-Q4: Pilot implementation of new procedures, internal audit.

20 January 2027: Full application of Regulation 2023/1230.

The role of the supplier of spare parts

A reliable supplier of MRO components should ensure:

• Declarations of conformity under Regulation 2023/1230 for safety components
• Technical documentation indicating the achieved PL/SIL
• Traceability from manufacturer to end user
• Advisory support for component classification
• Availability of CE certificates corresponding to the current legal framework

UNITEC-D GmbH as a specialized B2B supplier of industrial spare parts ensures full compliance of components with current European regulations. Each item in the catalog is accompanied by the necessary technical documentation and certificates of conformity.

Summary

Regulation (EU) 2023/1230 is not an abstract legislative innovation. These are specific requirements that affect the daily work of MRO services: from the purchase of a bearing to the overhaul of a production line. Businesses that ignore training run the risk of production shutdown, financial sanctions and criminal liability of officials.

Time for preparation is limited. Start by inventorying, classifying and auditing suppliers. Make sure your parts supply partner is ready to ensure compliance with the new requirements.

Certified industrial components with full technical documentation are available in the UNITEC-D E-Catalog - your reliable source of spare parts that meet the requirements of European regulations.

Reference documents

• Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJ L 165, 29.6.2023)
• Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (repealed from 20.01.2027)
• EN ISO 12100:2010 — Safety of machinery — General principles for design — Risk assessment and risk reduction
• EN ISO 13849-1:2023 — Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design
• EN 62061:2005+A2:2015 — Safety of machinery — Functional safety of safety-related electrical, electronic and programmable electronic control systems
• EN 60204-1:2018 — Safety of machinery — Electrical equipment of machines — Part 1: General requirements
• EN ISO 14119:2013 — Safety of machinery — Interlocking devices associated with guards
• Regulation (EU) 2024/1689 — Artificial Intelligence Act (for machines with AI components)
• DSTU EN ISO 12100:2016 — Machine safety. General design principles (IDT EN ISO 12100:2010)
• Association Agreement between Ukraine and the EU, Annex III — Technical regulations, standards and conformity assessment