Risk analysis vs Risk assessment - what is the difference in machine safety and CE marking?
Nov 11, 2025
When talking about machine safety, the concepts of risk analysis and risk assessment often come up. They are sometimes used as synonyms, but in the context of machine safety, they actually mean different things. Here we clarify the difference and show how they are related to CE marking, the Machinery Directive, and the upcoming Machinery Regulation.
What is a risk analysis?
A risk analysis is the first part of the risk management process for machines. It includes:
Establishing the machine's limitations (intended use and foreseeable misuse)
Identifying sources of risk and risky situations.
Estimating the risk for each source of risk and situation.
In other words: the risk analysis is about understanding and describing the risks.
What is a risk assessment?
A risk assessment goes a step further than the risk analysis. It includes both the analysis (1-3 above) and additionally:
Evaluating the risk and making decisions about the need for risk reduction.
Reducing the risk or eliminating the source using protective measures.
This means that a risk assessment is a comprehensive evaluation where one identifies sources of risk, assesses risks, and addresses or reduces the risks.
The connection to CE marking and the Machinery Directive
To CE mark a machine according to the Machinery Directive 2006/42/EC (and soon Machinery Regulation 2023/1230), a documented risk assessment is required. It is a central part of the technical file that authorities may request.
Without a proper risk assessment, a machine is illegal to sell or put into operation on the EU market.
How Noex helps you
With Noex, companies get a digital platform for technical manufacturer documentation including risk assessments, checklists, inspection protocols, and other support to facilitate CE marking of machines. The platform guides step by step and gathers all documentation in one place. The result:
Structure and traceability
Reduced risk of mistakes
Faster process towards CE marking
Would you like to see how Noex works in practice? Book a demo here!
FAQ - Common questions about risk analysis and risk assessment
What is the difference between risk analysis and risk assessment?
Risk analysis = identify and estimate risks. Risk assessment = analysis + evaluation of the need for measures followed by actions for reduction or elimination of risk.
Is risk assessment mandatory for CE marking?
Yes, according to the Machinery Directive, the upcoming Machinery Regulation requires all machines to have a documented risk assessment as part of the technical documentation.
Why should risk assessments be done at an early stage?
If safety is not considered from the beginning, it can become costly and difficult to integrate afterward. If it still needs to be addressed reactively, it often occurs at the expense of both availability and usability.
What happens if we neglect risk assessments?
Without proper documentation, you risk (in addition to an unsafe machine and poorer working environment) downtime with significant costs as a consequence, fines/penalties, recalls, insurance issues, and in the worst case, personal criminal liability.
