CE-Conformity Assessment Procedure
Systematic evaluation of your machine to ensure compliance with all relevant standards.
CE-Conformity Assessment Procedure
according to
- Machinery Direction
- Machinery Regulation (from 20.01.2027)
- Low Voltage Directive
Why CE-Conformity Is Important
The CE marking is much more than just a sticker on the machine.
With it, the manufacturer legally declares that the machine meets all applicable European requirements regarding safety, health protection, and environmental protection.
Without valid CE conformity, a machine may neither be placed on the market nor operated.
For manufacturers and operators this means:
- Legal certainty towards market surveillance authorities, professional associations, and insurers
- Protection of employees through standards-compliant design and consistent risk reduction
- Competitive advantage through documented quality and safety as well as legally compliant processes
When Is CE Conformity Required?
A CE assessment is always required when a machine or system:
- is newly developed or manufactured
- is significantly modified or extended
- is linked with other machines (e.g., production lines)
- is self-built / in-house developed and put into operation
Also applies when converting or modernizing existing machines:
As soon as a modification is classified as “substantial”, a new CE assessment must be carried out.
Examples of substantial modifications:
- Changes to safety-related control systems
- Introduction of new movement sequences or additional energy sources
- Removal, modification, or major changes to protective devices
- Increased performance parameters (cycle time, speed, pressure, etc.)
Such interventions can invalidate the manufacturer’s original safety verification and therefore require a new risk assessment as well as a renewed CE conformity assessment.
Note:
Not every modification counts as a substantial change. We support you with the professional evaluation according to the Machinery Regulation.The CE Conformity Procedure – Step by Step
Directives and Standards
Identification of all relevant EU directives (e.g., Machinery Directive, EMC Directive, Low Voltage Directive) and harmonized standards
Risk Assessment
Systematic identification and evaluation of all hazards throughout the entire life cycle of your machine or system – including the derivation and definition of suitable protective measures and required safety functions.
Implementation and Verification
Technical design and evaluation of the implemented protective measures – including the calculation of safety distances and the determination of the performance levels of functional safety.
Testing and Validation
Execution of internal production control based on the created test lists, acceptance protocols, and shut-off matrix for validating the implemented protective measures.
Technical Documentation
Design documentation, circuit diagrams, verification calculations (e.g., SISTEMA), test reports, as well as operating and maintenance manuals.
Declaration of Conformity & CE Marking
Issuance of the EC Declaration of Conformity and affixing of the CE marking on the machine.
Our scope of services
Standards and Directives
Consulting on the application of relevant directives and harmonized standards for your machine.
Risk Assessment
Execution or support of hazard analysis and risk reduction measures.
Functional Safety
Design and verification of safety functions (e.g., SISTEMA calculations).
Technical Documentation
Structured, audit-proof documentation for authorities, auditors, and insurers.
CE-Testing & Machine Modification
Evaluation of conformity even in case of modifications or expansions of existing machines
Training & Awareness
Practical training for design, maintenance, and operation teams.
Our Service
Run-Down Time Measurement
Precise determination of the run-down distances and times of your machines — for correctly dimensioned safety distances and maximum workplace safety.
Risk Assessment & Technical Documentation
Identification, evaluation, and documentation of all hazards — as the basis for standards-compliant and legally secure machine certification.
Recurring Inspections according to DGUV & VDE
Regular safety and functional inspections in accordance with DGUV and VDE requirements — for maximum operational safety and legal certainty.
OT security
We carry out comprehensive IT security analyses of your industrial plants and systems.