Don't miss out on any news and changes relating to CE! Register now for the CE InfoService
Share Article
A considerable amount of specialist knowledge and experience as well as time is required to prepare the necessary documentation for risk assessment and CE marking as required by law. To better control these factors, it is worthwhile for companies of all sizes to use special software systems that can provide targeted support for the legally required risk reduction measures or in the conformity assessment procedure.
This article highlights basic considerations for the use of software systems and provides a checklist template for analysing the requirements of a software system.
The Machinery Directive and Machinery Regulation require documentation of the measures taken for risk reduction. Neither regulation specifies how this documentation must be provided. Legible handwritten records are theoretically just as acceptable as documents created in Word or Excel.
However, the legislator clearly specifies how a risk assessment and risk reduction must be conducted:
Machinery Directive 2006/42/EC, Annex I, General principles, Point 1
The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.
By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall
— determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof, — identify the hazards that can be generated by the machinery and the associated hazardous situations, — estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence, — evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive, — eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b) (…)
This method of performing a mandatory risk assessment is specified in section 1.1.2, which lists the individual steps:
Machinery Directive 2006/42/EC, Section 1.1.2. b)
In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given:
— eliminate or reduce risks as far as possible (inherently safe machinery design and construction) — take the necessary protective measures in relation to risks that cannot be eliminated, — inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.
The new Machinery Regulation (EU) 2023/1230 also incorporates this obligation to perform a risk assessment with virtually unchanged wording:
Machinery Regulation (EU) 2023/1230, Annex III, Part B General principles, 1.
The manufacturer of machinery or a related product shall ensure that a risk assessment is carried out in order to determine the essential health and safety requirements which apply to the machinery or related product. The machinery or related product shall then be designed and constructed to eliminate hazards or, if that is not possible, to minimise all relevant risks, taking into account the results of the risk assessment.
By the iterative process of risk assessment and risk reduction referred to in the first subparagraph, the manufacturer shall:
a) determine the limits of the machinery or related product, which include the intended use and any reasonably foreseeable misuse thereof; b) identify the hazards that may be generated by the machinery or related product and the associated hazardous situations; c) estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence; d) evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Regulation; e) eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b) (…)
Machinery Regulation (EU) 2023/1230, Section 1.1.2. b)
In selecting the most appropriate methods, the manufacturer shall apply the following principles, in the order given:
i. eliminate hazards or, if that is not possible, minimise risks (inherently safe machinery or related product design and construction); ii. take the necessary protective measures in relation to risks that cannot be eliminated; iii. inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.
‘That's not possible in our company.’
Many companies do not act in accordance with these requirements. Instead, one person is asked to perform a ‘risk assessment’ after the machine has been built. What is called risk assessment is in reality a final check and has nothing to do with the legally required ‘safety integration’ into the design processes. As a result, hazards that could have been identified during the design phase, or even should have been identified, are no longer recognised. If they are, the risk reduction solutions often do not comply with the prescribed three-step procedure set out in section 1.1.2 of the Machinery Directive or Machinery Regulation.
CE representatives and CE coordinators in companies are sometimes aware that the legal requirements are not being met in this form. One reason that is frequently given is: ‘That's not possible in our company.’ What they mean is that it is impossible to get all designers to integrate safety considerations into the design process.
This is indeed a serious problem that is frequently encountered in the industry. However, the solution is not to purchase a software system. Clearly defined internal processes are required to ensure compliance with legal obligations. It is not effective to implement a software system that is then not used by anyone.
Requirement analysis for a software system
The logical consequence of this is that the implementation of a software system must be prepared accordingly. Structures must be created that ensure that the functions available in the systems can be used profitably. However, the first question that arises here is what is actually needed. The checklist linked at the end of this article will help you determine the requirements for a software system for your company.
Word or Excel
Often, companies resort to the familiar systems they already have in place, such as Word or Excel. This seems like a quick solution that does not require the purchase of specialised software or training on a new system. However, it is advisable to check the suitability of Word or Excel for a software system based on a requirements analysis. In the medium term, high costs can arise if it is suddenly discovered that these systems cannot achieve important goals, e.g. automatic conversion of projects when standards change, checks for up-to-date information when copying projects, and the like.
Use CE documentation as a knowledge resource
New projects are often based on an existing project. This means that the effort invested in documenting the existing project can be put to good use again. This is particularly advantageous if the people who designed the previous machine are no longer with the company. Depending on the scope of the project, archived knowledge can save a great deal of time when developing the new machine. However, particular care must be taken when reusing archived specialist knowledge.
This is precisely where software systems reveal their full potential by providing targeted and systematic support. Structured data storage and cross-checks with other data, for example in an updated standard database, enable checks to be carried out in a matter of seconds that would otherwise take several days or weeks to complete manually.
Product note
Safexpert 9.1 - The CE software already supports the new Machinery Regulation (EU) 2023/123030
Since version 9.1, Safexpert has been providing you with targeted support when switching to the new Machinery Regulation (EU) 2023/1230. For machines with a long service life that are placed on the market from 20 January 2027, you can now use the CE guide in accordance with the new Machinery Regulation!
More information
Practical experience shows that many users primarily want a software system that is as easy to use as possible. However, it is only during practical work that it becomes apparent that certain functions and automatic processes are actually required.
It is therefore a good idea to start by determining which requirements the selected software system must meet. This will eliminate all systems that do not meet these requirements from the very beginning.
Checklist: Needs analysis
What must your CE software be able to do?
Use this list to evaluate which requirements are particularly important for your company. If necessary, add your own points to the list that you consider important.
Based on the checklist, we can offer you particularly targeted advice on our CE software Safexpert. Simply send us the checklist by email or contact us by email or phone to arrange an individual consultation appointment, during which we will be happy to discuss your requirements with you.
Contact us by email
Contact us by phone
Posted on: 2025-06-25
Specialist for CE marking and Safexpert. Since 2023 in product management at IBF. Before that, he worked as a design engineer in special machine construction and as an occupational safety expert (SiFa). Studied mechanical engineering at the OTH Regensburg with a focus on production and automation technology.
E-Mail: christian.aumann@ibf-solutions.com | www.ibf-solutions.com
We will inform you free of charge by e-mail about new technical articles, important standard publications or other news from the field of mechanical and electrical equipment safety or product compliance.
Register
CE software for systematic and professional safety engineering
Practical seminars on aspects of risk assessment and ce marking
With the CE InfoService you stay informed about important developments in the field of product safety.