Introduction to Market

What Does “Placing Machinery on the Market” Mean?

According to the Machinery Directive 2006/42/EC, placing machinery on the market means the first making available of a machine on the European Union market for sale or use.

The steps involved in placing machinery on the market include:

• Making the machine available on the EU market: The machine must be accessible to end users.
• Sale or use: The machine may be sold or used by the manufacturer or other economic operators.
• CE marking: The machine must bear the CE mark, confirming its compliance with the Directive’s requirements.
• EU Declaration of Conformity: The manufacturer must draw up an EU Declaration of Conformity, certifying that the machine meets all applicable requirements.
• Documentation: Required documentation—including operating, assembly/disassembly instructions, schematics, and drawings—must be prepared and made available.
• Conformity assessment: In certain cases, conformity assessment by a Notified Body is required, especially for machines presenting significant hazards.

Placing machinery on the market is a critical stage in introducing it to the EU market and must be carried out in accordance with the Directive to ensure user safety and legal compliance.

Legal Basis Governing the Placing of Machinery on the Market

The legal acts regulating the placing of machinery on the market are:

• Machinery Directive 2006/42/EC: Establishes safety and health requirements for the design and construction of machines placed on the EU market.
• Regulation (EU) 2019/1020: Covers market surveillance and product compliance, including machinery.
• Act of 30 August 2002 on the Conformity Assessment System (Poland): Implements EU conformity assessment requirements into Polish law.

The key legal instruments are:

1. Machinery Directive 2006/42/EC
   • Main legal basis for placing machinery on the EU market.
   • Sets requirements for safety, health, and environmental protection.
   • Mandates CE marking and issuance of the EU Declaration of Conformity.
   • Defines obligations of manufacturers and importers regarding documentation and conformity assessment.
2. Regulation (EU) 2016/426
   • Establishes rules for designation of Notified Bodies authorised to carry out conformity assessments.
   • Specifies competence and independence requirements for Notified Bodies.
3. Act on the Conformity Assessment System (Journal of Laws 2023, item 1229)
   • Implements EU conformity assessment rules into Polish law.
   • Outlines obligations of manufacturers, importers, and distributors regarding CE marking and documentation.
4. Act on Machinery Safety (Journal of Laws 2023, item 155)
   • Complements EU and national requirements on machine safety.
   • Specifies additional obligations for manufacturers, importers, and users.

Legal Framework from 20 January 2027 Onward

From 20 January 2027, Regulation (EU) 2023/1230 of 14 June 2023 on machinery will enter into force, replacing the Machinery Directive 2006/42/EC. This Regulation updates requirements for design, manufacture, and market placement of machinery to reflect technological advances and emerging hazards.

Key changes introduced by Regulation 2023/1230 include:

• Expanded definition of machinery: Includes not only traditional machines but also digital safety components and small personal transport devices such as e-scooters and e-bikes. 
• New conformity assessment procedures: Introduces an additional module (Module G) and requires third-party assessment for high-risk machines listed in Annex I. 
• Digital instructions: Safety information will be provided in digital format by default, with paper versions available on request. 
• Alignment with the NLF: Harmonises rules with other EU product safety regulations. 

As a Regulation, it will apply directly in all Member States without national transposition. Economic operators planning to place machinery on the market after 20 January 2027 should familiarise themselves with the new requirements and adapt their products and procedures accordingly.

Technical Documentation Required Before Placing Machinery on the Market

The technical documentation required before placing machinery on the EU market includes:

1. Description of the machine:
   • Detailed technical description
   • Schematics, drawings, and photographs
   • Technical specifications
2. Operating instructions:
   • Complete operating manual in the relevant language(s)
   • Assembly, disassembly, maintenance, and inspection instructions
3. Safety instructions:
   • Information on hazards and protective measures
   • Guidance for safe use
4. Noise and vibration data:
   • Measurement results
   • Mitigation measures
5. Energy consumption data:
   • Energy consumption figures
   • Efficiency test results
6. Risk assessment report:
   • Analysis of risks associated with machine use
   • Protective measures implemented
7. Test and examination reports:
   • Laboratory test reports (e.g. mechanical strength, electrical insulation)
   • Functional and safety test reports
8. Certificates and Notified Body reports (if required):
   • Certificates of conformity
   • Notified Body assessment reports
9. EU Declaration of Conformity
10. CE marking

Documentation requirements may vary depending on machine type, complexity, and risk category. Additional documentation (e.g. environmental protection, quality management, data protection) may be required. Always verify the latest guidance before market placement.

Cost of Placing Machinery on the Market

The cost of placing machinery on the market depends on its type, complexity, and legal requirements. More complex machines incur higher expenses for documentation, testing, and conformity assessment. Fees for Notified Bodies, CE marking preparation, and adaptation to target-market standards also affect costs. Additional expenses may include risk analyses, expert services, and compliance with environmental or safety regulations. Each project is priced individually—contact us for a quotation within 48 hours.

Legal Liability of the Manufacturer When Placing Machinery on the Market

Manufacturers bear significant legal liability when placing machinery on the EU market, covering several key areas:

1. Compliance liability:
   • Ensure the machine meets all safety, health, and environmental requirements of the Machinery Directive 2006/42/EC.
   • Conduct conformity assessment, draw up the EU Declaration of Conformity, and affix the CE marking.
2. Documentation liability:
   • Prepare complete technical documentation, including all required manuals and drawings.
3. Product-defect liability:
   • Be liable for damages caused by faulty machinery, including personal injury and property damage.
4. False CE marking:
   • Liable for administrative, criminal, and civil penalties if CE marking is fraudulent.
5. Non-conformity liability:
   • May be required to recall non-conforming machines or halt production.
6. Regulatory-breach liability:
   • Accountable for breaches of machine safety, environmental protection, or other legal provisions.
7. Liability for harm caused:
   • Subject to compensation claims from injured parties.

Liability may be limited by contractual agreements with importers, distributors, or end users, but the manufacturer remains primarily responsible for legal compliance and user safety.

Common Mistakes When Placing Machinery on the Market

The most frequent errors include:

• Incorrect CE marking
• Missing or improper EU Declaration of Conformity
• Incomplete or incorrect technical documentation
• Insufficient or flawed risk assessment
• Missing or improper machine testing
• Non-compliance with technical standards
• Omitted noise and vibration documentation
• Failure to meet energy-consumption requirements
• Incorrect CE-mark documentation
• Non-compliance with national regulations
• Lack of cooperation with a Notified Body (when required)
• Poor storage and archiving of documentation

To avoid these mistakes, manufacturers should thoroughly understand legal requirements, perform diligent conformity assessments, and prepare complete documentation. When in doubt, engage a Notified Body and keep up with training and expert advice.

The Role of GCB in Placing Machinery on the Market

GCB supports manufacturers, importers, and distributors at every stage of placing machinery on the EU market—from procurement through conformity assessment to market preparation. Our services comply with the Machinery Directive 2006/42/EC and the incoming Regulation 2023/1230.

Role of GCB in Machinery Procurement

We conduct technical and legal evaluations of new and used machines before purchase. We assess documentation completeness and EU-compliance, identifying any formal or technical gaps. This minimizes costly purchasing errors and potential sanctions upon commissioning.

Role of GCB in Machinery Sales

We provide end-to-end assistance in preparing machinery for sale. Our expertise covers technical-documentation review, conformity-assessment execution, drafting the EU Declaration of Conformity, and CE marking. We also help adapt machines to current technical and legal standards, enhancing safety, transparency, and market competitiveness.