Whether you are a manufacturer, a builder of machinery for internal use, a distributor or an importer, we can configure our services to meet your specific needs
Machinery Directive
CE compliance for machinery: risk assessment, Technical File preparation and regulatory consultancy
What is the Machinery Directive?
The Machinery Directive establishes the essential health and safety requirements for the design, construction and marketing of machinery within the European market.
It applies to machinery and production lines, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery.
As of January 20, 2027, it will be replaced by the new Machinery Regulation.
Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230
Tailored solutions for businesses of all sizes
Mandatory Compliance
This applies to individual machines, full production lines, complex integrations or machinery imported from non-EU countries. Anyone who designs, manufacturers, assembles or imports machinery intended for the European Union market must comply with thee regulations.
A clear, structured workflow to achieve CE compliance
We guide our client through every step of the journey toward CE marking
Assessment of applicable EHSRs
Identification and verification of the applicable Essential Health and Safety Requirement (EHRS) in accordance with the Directive and machine-specific harmonized standards. This assessment ensures that every machine placed on the market meets the minimum requirements to guarantee the safety of operators and exposed persons. The first step involves identifying the relevant EHSRs, which vary based on the machine type, its intended use and its specific characteristics.
Risk Assessment
We assist you in performing the risk assessment, which is mandatory under the Machinery Directive. We identify potential hazards, evaluate the associated risks and define the necessary protective measures. Our approach helps you draft an effective document that complies with regulatory standards and can be seamlessly integrated into the Technical File
Compliance Testing
Compliance Testing is used to verify that machinery meets all specified technical requirements. These may include electrical, mechanical or functional test. All procedures must be documented and performed by qualified laboratories. The results provide objective evidence of safety and adherence to the standards required for CE marking.
Manuals and Documentation
The User and Maintenance Manual is a mandatory requirement for CE Marking. It must be comprehensive, clear and provided in the official language of the country of destination. It includes instructions for the safe operation of the machine, maintenance procedures, emergency protocols and information on residual risks. The manual is an integral part of the documentation required by the Machinery Directive.
Compilation of the Technical File
We prepare your machinery’s Technical File by gathering all required documentation: risk assessments, electrical and fluid power schematics, manufacturing drawings, design calculations, component certificates and operating instructions. A complete Technical File is essential to demonstrate compliance during inspections or audits by the competent authorities.
Why choose our laboratory?
A laboratory that combines technical expertise, regulatory proficiency and hands-on-knowledge of machinery
We provide tailored solutions designed to meet your specific requirements. Our expertise ranges from complex machinery – requiring precise risk assessments covering everything from electrical equipment and mechanical components to safety-related control circuits and the determination of the appropriate Performance Level (PL) – to small, custom-built machines ensuring they are fully safe for the operators who use them. Additionally, we offer support in auditing the documentation of outsourced components to help you avoid any unwelcome surprise during the compliance process.
FAQ
When must a production line be CE marked?
An assembly of machines – often referred to as a “line” – is defined as a group of machines that must operate in an interconnected manner and re controlled by a common control system. In this case, even if the individual components already carry the CE mark, the entire line must be certified as a single, integrated machine.
I have old machinery. What do i need to do to ensure compliance?
If the machines were manufactured prior to 1996, a safety audit must be conducted in accordance with Annex V of Legislative Decree 81/08 (the Italian Consolidated Law on Health and Safety at Work).
For machinery manufactured after 1996 that already carries the CE marking, you must verify that all safety devices are present and fully functional. Furthermore, if these components are more than 20 years old, they may need to be replaced to ensure continued reliability and compliance with current safety standards
Is my equipment a machine or a "partly completed machine"?
The distinction between a machine and a partly completed machine depends on whether the equipment has a specific application in its own right. A partly completed machine cannot perform a specific function on its own and is intended only to be incorporated into or assembled with other machinery to form a final machine.
How do i ensure compliance for a machine built for internal use?
Even for machinery designed and built for internal use (self-built), you must follow the complete CE marking process required for machines intended for sale. Specifically, the following activities must be carried out:
- Risk Assessment: in accordance with Annex I of the Machinery Directive 2006/42/CE
- Compilation of the Technical File, containing all documentation required by Annex VII
- Drafting of the operating instructions (User Manual)
- Execution of functional tests and verifications
- Issuance and signing of the EC Declaration of Conformity
I ordered machinery from outside the EU. How do I ensure it is compliant?
If the manufacturer has appointed an Authorized Representative established within the European Union, and the latter has issued a Declaration of Conformity stating that the machine meets the requirements of the Machinery Directive (2006/42/EC) or the Machinery Regulation (EU 2023/1230), the end-user is only required to conduct a residual risk assessment and implement any necessary additional safety measures to ensure the safe operation of the machine within their specific operational context.
Conversely, if the manufacturer does not have an Authorized Representative within the EU – meaning there is no legal entity responsible for compiling the Technical File and drafting the Declaration of Conformity in their own name
Should I apply the new Regulation or the current Machinery Directive?
Until January 20, 2027, all new machinery must be designed and manufactured in accordance with Directive 2006/42/EC. From that date onward, the new Machinery Regulation (EU) 2023/1230 will become mandatory. However, for series-produced machinery, you should not wait until 2027 to verify compliance with the new Regulation; it is advisable to begin the transition now to ensure a seamless shift to the new requirements.
What documentation do i need to export machinery outside the EU?
There is no simple answer, as the requirements depend entirely on the specific regulations in force within the destination country. If the machinery is intended exclusively for non-EU countries, CE marking is not required. However, if the machine is also placed on the European market, CE marking remains mandatory.
Related Services
Do you need more information?
Contact us for more information or to request a free quote
Ask for information
