New Machinery Regulation - Support from Safexpert

Figure 1: Screenshot of Safexpert 9.1 - Step by step to CE according to EU Machinery Regulation 2023/1230
 

The software for CE marking

Safexpert is the standard software for risk assessment and CE marking in accordance with the Machinery Directive, Low Voltage Directive and, of course, the Machinery Regulation. Among other things, manufacturers of machines and systems are guided step by step through the conformity assessment procedure in the so-called CE Guide.

Quickly informed:

• Not yet familiar with Safexpert? You can find more information on the Safexpert page or in a free WEB presentation.
• To make the changeover as quick as possible, we have fundamentally revised the relevant chapters of the Safexpert manual so that self-taught familiarisation is of course possible.
• For all those who want even more convenience, we have designed a half-day changeover training, which is aimed in particular at people who are still using Safexpert 8.6 or earlier versions 

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To the changeover training

Changes due to the new Machinery Regulation

With the replacement of the Machinery Directive 2006/42/EC by the new Machinery Regulation (EU) 2023/1230, there are changes to the conformity assessment procedures - and therefore also to the CE Guide.

Some of these changes are of a purely editorial nature and concern the numbering of articles and annexes as well as terminology. One far-reaching change, for example, concerns the procedure for "high-risk machinery" (formerly "Annex IV machinery"). In future, a distinction will be made between two subtypes of high-risk machinery (type A and type B), for which different procedures, so-called modules, are to be applied.

You can find more information on this in our technical article or in our seminar "Changeover to the new Machinery Regulation". 
 

Version 9.1 available since 15 April 2024

Our aim was to provide customers with very long project durations in particular with a customised Safexpert version as quickly as possible. This is why the preliminary work on the software began with the publication of the first drafts of the Machinery Regulation, so that we can now offer our customers planning security with a lead time of over 2 1/2 years until mandatory application in spring 2027.
 

Free of charge as part of the Safexpert maintenance agreements

Customers with a current maintenance agreement for the CE Guide in accordance with the Machinery Directive will receive the update and the associated feature enhancements free of charge.
 

What's new in Safexpert 9.1

You can find an overview of the numerous improvements, optimisations and technical changes in our version history. We have summarised the changes in connection with the new EU Machinery Regulation for you below.
 

New CE Guide in accordance with EU Machinery Regulation 2023/1230

As mentioned above, the central change is a completely new step-by-step assistant that guides you through the conformity assessment procedure in accordance with the Machinery Regulation. This new wizard naturally takes into account the innovations relevant for manufacturers, such as:

• Distinguishing whether it is a new product or a significant change within the meaning of the EU Machinery Regulation.
• For "high-risk machines": Differentiation of which type (type A, type B) they fall into and automatic selection of the relevant conformity assessment procedures.
• Possibility to define the relevant sections of applied standards that should be printed on the declaration of conformity.
• Completely NEW: Requirements lists according to Machinery Regulation - hand-in-hand fulfilment of the legally required requirements with the performance of the proven risk assessment according to EN ISO 12100 (more on this below)
• Aids for conformity assessment procedures for "high-risk machinery"
• New templates for EU Declarations of Conformity and EU Declarations of Incorporation, taking into account the new requirements from the Machinery Regulation (formal details and new features, e.g. the option of colour illustrations on declarations of conformity). e.g. the option to include colour illustrations on the declaration of conformity, installation addresses (for the required special cases), etc.)

Figure 2: Screenshot of Safexpert 9.1 - Clarifying the application of relevant standards in the project
 

Requirements lists: Intelligent linking of regulation requirements and risk assessment 

For users who are already familiar with the CE software, the new "Requirements list" feature is probably the biggest innovation. This is a checklist of the essential requirements from the EU Machinery Regulation, the fulfilment of which is verified in the project. Safexpert uses a multi-stage concept to ensure that no important points are forgotten and that no unnecessary bureaucratic work is carried out:

• The "conditions" system in Safexpert allows you to control which aspects are not applicable to your project when you create it. Despite preselection, you can see these points in the project and can override the convenient preselection - which may be relevant for special cases
• All entries in the list, which is clearly displayed in tab 4 of the CE Guide, contain the original texts from the Machinery Regulation in the detailed view. This allows you to determine the relevance of the requirement at a glance.
• The list contains not only entries from Annex III (essential requirements), but also additions from different articles - this is necessary because, for example, linguistic requirements or certain requirements for digital instructions have (unfortunately) been defined by the EU legislators in different parts of the regulation.
• In the project, you have the choice of either assessing the relevance of the requirements before processing the risk assessment (which are not already predefined by conditions) or performing this step during the risk assessment, or a mixture of both. Safexpert gives you the freedom to follow your desired workflow. 
• In the risk assessment, you add the requirements to your measures that are fulfilled by the corresponding measure. This creates a link between the legal requirements from the Machinery Regulation and your measures from the risk assessment. 
• In the overview list in tab 4, you can also see which (different) measures have been used to fulfil legal requirements. 
• In tab 7 (production monitoring), you check the compliance of the machine with the technical files as usual and now also with the essential requirements. 

Figure 3: Screenshot of Safexpert 9.1 - Open risk assessment and edit basic requirements

Features from previous versions that make the changeover easier

Even before version 9.1, Safexpert supported you in familiarising yourself with the new requirements thanks to the "Knowledge Base" and "Document comparison" features, which you will of course continue to benefit from with version 9.1.
 

Knowledge Base

While reading standards and guidelines documents, the knowledge base provides you with additional expertise and experience directly in the relevant section of the document. This provides them with important information on the spot, such as the fact that the date of entry into force of the Machinery Regulation has been changed in the meantime.

Figure 4: Corrigendum to the Machinery Regulation in the Safexpert Knowledge Base

This offers the following advantages for the new Machinery Regulation:

• Changes and corrections to the regulation are displayed directly in the relevant section
• EU guidelines and other explanations are added as soon as they are available
• Further helpful information can be found directly where you need it - without having to search!
• And best of all: Safexpert users with a licensed StandardsManager (Compact package or higher) receive access to the general knowledge base free of charge!

Here you can find more information about the Knowledge Base.
 

Document comparison

The document comparison provides you with a comparison of a predecessor document with its successor and allows you to see directly which sections have been changed, deleted or added. The respective sections can be opened in full text for a comparison.

Figure 5: Safexpert document comparison as an interactive correlation table for the Machinery Directive and Machinery Regulation
 

For the new Machinery Regulation, this helps you as follows:

• There is an interactive correlation table between the Machinery Directive and Machinery Regulation, link destinations open the full text directly at the desired section.
• This results in a comparison of the changes in the two full texts - because often the details in the changes are decisive.
• Use this helpful comparison also for all standards that will be revised in the future due to the Machinery Regulation.

Here you can find more information about the document comparison.
 

How to benefit when switching to the new regulation

When you switch to the new regulation, your project data (risk assessments, etc.) will be available in machine-readable form. This offers you the following advantages:

• Digital analyses inform you, for example, about amended standards that have presumption of conformity under the current Machinery Directive, but for which a successor standard already exists. This update monitoring is also performed directly in the risk assessment for standards and directives that were used for a risk reduction measure. You can use the Change assistant to display the successor document and find out what has changed.
• Conversions: With version 9.1 of Safexpert, it is possible to select a CE Guide in accordance with the Machinery Regulation. Of course, you can convert existing projects based on the current Machinery Directive to the new guide in accordance with the Machinery Regulation. This allows you to use existing data and only add data that is additionally relevant due to the new Machinery Regulation.