EU legislation
Defines scope, obligations, procedures and responsibilities.
European legislation · CE marking
The European roadmap
for compliant machinery.
Conformity starts with the product, runs through directives, regulations and harmonised standards, and leads to the technical file, EU declaration and CE marking.
European framework
CE marking is the outcome.
Engineering comes first.
European machinery legislation is a coordinated system of obligations, technical requirements and responsibilities. Each product has a specific combination: identifying it early prevents late corrections and makes the entire conformity process verifiable.
Harmonised standards
Support engineering decisions and the presumption of conformity.
Directives and regulations
One machine.
Multiple regulatory layers.
The map starts with the machinery and its integrated technologies. Every reference must be confirmed against the actual product.
01Machines
Regulation (EU) 2023/1230The new reference for machines, related products and partly completed machinery. It will replace Directive 2006/42/EC from 20 January 2027.
02Machines · current framework
Directive 2006/42/ECDefines essential requirements for safety and health, technical file and manufacturer’s obligations up to the passage to the new Regulation.
03Electromagnetic compatibility
2014/30/EU DirectiveRegards emissions and immunity of machines with drives, inverters, electronics, sensors and complex paintings.
04Cyber Resilience Act
Regulation (EU) 2024/2847Introduces cybersecurity requirements for products with digital elements and coordinates safety, security and vulnerability management.
05Artificial intelligence
Regulation (EU) 2024/1689It becomes relevant when decision-making or adaptive functions affect safety, control or interaction with the operator.
06Low voltage · LVD
2014/35/EU DirectiveTo be evaluated for electrical equipment and products within specific voltage limits, coordinating it with the machine framework.
07ATEX product
2014/34/EU DirectiveFor devices and systems intended for potentially explosive atmospheres: categories, triggers, marking and documentation.
08Pressure equipment · PED
2014/68/EU DirectiveIt can involve machines with pneumatic, hydraulic or process circuits according to fluids, pressures, volumes and categories.
09Radio Equipment · RED
2014/53/EU DirectiveFor machines and subsystems with Wi-Fi, Bluetooth, modem, antennas or IoT modules.
Assessment method
Product first.
Then the standard.
Intended use, market, installation environment and integrated technologies determine the conformity route.
Define the product
Expected use, machine limits, configuration and role of the economic operator.
Mapping EU acts
Directives and regulations applicable, including possible overlaps.
Select standards
Harmonized type-A, type-B and type-C standards useful for design and verification.
Building the evidence
Analysis, tests, instructions for use, declarations and technical files consistent with each other.
Frequently used technical standards
From the requirement
to the engineering decision.
Harmonised standards are not laws, but they are central tools for designing, verifying and documenting conformity.
Risk assessment and reduction
Identification of hazards, risk estimation and choice of reduction measures.
Open in the UNI cataloguesafety-related command systems
Design of safety functions through Performance Level, categories, MTTFd, DCavg and CCF.
Open in the UNI catalogueSafety Distances
Detachments to prevent the attainment of dangerous areas with upper and lower limbs.
Open in the UNI catalogueElectrical equipment
Circuits, controls, protections, stops, wiring, markings and electrical checks.
Open in the UNI catalogueInterlocking devices
Choice and design of interlocks associated with guards and prevention of defeat.
Open in the UNI cataloguePlacement of means of protection
Minimum distances for sensitive devices according to stop times.
Open in the UNI catalogueRegulatory context analysis
Before engineering begins,
clarify the framework.
We analyse the machinery, function, sector and technologies to identify obligations, technical standards, documents and the conformity route.
Request a regulatory analysis