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Machinery Regulation, Cyber Resilience Act (CRA) and IEC 62443

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1. Introduction

Many machine manufacturers are currently facing new mandatory cybersecurity requirements under the EU Cyber Resilience Act (CRA). They are wondering how best to implement these requirements and often come across the widely used IEC 62443 series of standards for industrial cybersecurity. However, reading these standards quickly raises questions: How do you classify machines in this set of standards? Are machines, in the sense of IEC 62443, more like components or already complete systems? And what role does the machine manufacturer play in this – are they more like the manufacturer (product supplier) or the integrator?

This article provides an overview of the most important definitions and explains how machine manufacturers can position themselves in the area of conflict between the Machinery Regulation, the Cyber Resilience Act and IEC 62443.

2. Terms and definitions

First, it is helpful to clarify a few key terms – from the legal definition of a machine to the product term in the CRA to the relevant roles and concepts from IEC 62443.

Machinery (definition according to the EU Machinery Regulation 2023/1230)

The new Machinery Regulation (EU) 2023/1230 defines very precisely what is meant by a ‘machine’. Put simply, the term ‘machinery’ covers any assembly of linked parts or devices, at least one of which is movable, which are joined together for a specific application and which are driven by a source of energy other than directly applied human or animal effort. This definition includes various variants, e.g. combinations of several machines or subsystems that function together as a unit. Even machines that only lack the appropriate software for operation fall under the broad definition of machinery in the regulation. For machine builders, this means that their products – whether individual machines or interlinked machine lines – are legally considered machinery within the meaning of this regulation and must meet the relevant (safety) requirements.

Product with digital elements (definition according to the Cyber Resilience Act)

The Cyber Resilience Act (CRA) applies to ‘products with digital elements’ that are made available on the European market. This refers to ‘a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately’ if their intended purpose or reasonably foreseeable use involves a direct or indirect logical or physical data connection with a device or network. The definition is very broad and encompasses both software and hardware devices, from small IoT devices to complex automation systems. This spectrum also includes (smaller) machines and (larger) machine systems, which are covered by both the Machinery Regulation and the CRA.

It is relevant here that modern machines today usually contain digital elements for networking and thus constitute a ‘product with digital elements’, i.e. they fall within the scope of the CRA. According to the CRA, the manufacturer of such a product (in this case, the machine manufacturer) is the company that "develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, [...].

From 11 December 2027, these manufacturers will only be allowed to place products on the market if they comply with the requirements of the CRA. These requirements relate to the technical safety of the product itself, documentation requirements, post-market obligations such as vulnerability and update management, and thus also the monitoring of products in the field, as well as, where applicable, requirements for internal processes, keyword: secure product development process.

IEC 62443: Roles and relevant concepts

IEC 62443 is an international series of standards dealing with the cybersecurity of industrial automation and control systems (IACS). According to IEC 62443, an IACS is named as ‘a collection/combination of personnel, hardware, software and policies involved in the execution of an industrial process and influencing its safe, secure and reliable execution’. In short, it is the combination of technical systems (hardware, network), their software, and the associated guidelines and people who operate the system with the aim of controlling an industrial process safely, securely and reliably. To this end, an IACS consists of controllers (PLCs), sensors & actuators, operating elements (HMIs) and industrial networks such as ProfiBus or SCADA systems.

IEC 62443 distinguishes between different roles, each of which has different requirements to fulfil:

  • Manufacturer / Product Supplier: Traditionally, these are manufacturers of components such as controllers, sensors, etc., i.e. those components that are used in IACS. The extent to which machine manufacturers also play the role of ‘manufacturers according to IEC 62443’ is discussed below.
  • System integrator (integration service provider): This role is responsible for the interaction of different components. It therefore takes on the design of a system, including the selection of suitable components (e.g. with adequate security features) and the correct integration of these components (e.g. correct configuration, etc.). IEC 62443 usually assumes that this integration takes place in close coordination with the operator. Although this is sometimes the case in mechanical engineering (especially in industrial plant engineering), it is usually not the case, particularly with regard to series-produced machines such as machine tools. The potentially tempting assumption that ‘machine manufacturer according to the Machinery Regulation’ = ‘integrator according to IEC 62443’ is therefore too simplistic and is at least not always true and, in particular, (unfortunately) not entirely true.
  • Operator (asset owner): IEC 62443 also defines the operator and their obligations. The obligations are, in particular, the operation and maintenance of systems, which includes compliance with cybersecurity guidelines such as access restrictions (through physical access protection, as well as through authentication such as username/password or similar). The training of personnel is also the responsibility of the operator. There are certain similarities here to operator responsibilities in occupational health and safety.
  • IEC 62443 defines a fourth role, that of the maintenance service provider. These are service providers who are responsible for the maintenance of an IACS. This is relevant for machine manufacturers insofar as manufacturers who offer service contracts should check whether and which obligations they thereby assume with regard to cybersecurity.


Figure 1: ISA Global Cybersecurity Alliance – Roles and Responsibilities in the Security Lifecycle
 

In addition to defining roles, IEC 62443 also distinguishes and defines components/products and systems, and consequently between requirements at component level and at system level. This classification is of limited accuracy for mechanical engineering. Rather, the classification of whether a machine is more of a component/product or more of a system should be understood as a spectrum, with the outer ends of the spectrum roughly corresponding to the definitions in IEC 62443, as listed below.

In addition to defining roles, IEC 62443 also distinguishes and defines components/products and systems, and consequently between requirements at component level and at system level. This classification is of limited accuracy for mechanical engineering. Rather, the classification of whether a machine is more of a component/product or more of a system should be understood as a spectrum, with the outer ends of the spectrum roughly corresponding to the definitions in IEC 62443, as listed below.

  • According to IEC 62443, components/products are individual building blocks, such as PLCs, routers, HMIs, sensors, etc.
  • Systems are a combination of several components/products that represent automation solutions, e.g. production facilities or similar.

3. Mechanical engineers in IEC 62443: manufacturers or integrators?

Against the background outlined above, the central question now arises: Where does the classic mechanical engineer fit into this role model of IEC 62443? Are they a component manufacturer, a system integrator – or both? And should their machines be treated as products or as systems within the meaning of the standard?

Anyone who takes a closer look at IEC 62443 will quickly come to the conclusion that the series of standards was not primarily developed for machine builders. They play a somewhat mixed role in this context, as they build and deliver complex technical systems, but often act as product suppliers:

  • A standard machine manufacturer who sells a machine (or machine system) as a series-ready product to many different customers without customising each individual installation on site behaves largely like a product manufacturer. They develop the machine at their own risk, install standardised components (PLC, drives, HMI, etc.) and deliver a finished machine to the customer, who then commissions it themselves. In IEC 62443 terms, this largely corresponds to the role of the product manufacturer, except that the ‘product’ delivered here is not a single device, but a machine consisting of many parts. In this case, the machine manufacturer assumes responsibility for the safe design of the machine as a whole, similar to how a component manufacturer is responsible for its device. During development, they usually have no direct contact with the future operator, apart from general market requirements.
  • A special machine manufacturer, on the other hand, who designs a tailor-made plant or production line in close consultation with an individual customer, also acts as an integration service provider. They design and build a unique solution with a specific design for the customer and, if necessary, integrate existing customer systems or requirements. Here, the activity largely corresponds to the role of the system integrator. The machine manufacturer works with the operator to define and implement the safety requirements for this specific system. The perspectives of the operator and the integrator thus converge. In such cases, the machine manufacturer can certainly be regarded as an integrator within the meaning of IEC 62443. However, as described above, this classification should not be viewed as absolute, but rather as falling more within the scope of the integrator on the manufacturer -> integrator spectrum, which does not mean that certain aspects of the manufacturer role according to IEC 62443 are not still relevant.

Component or solution approach? In terms of safety, a single machine cannot be categorised unequivocally as a mere component or a fully-fledged IACS solution – it depends on the size and complexity of the machine. Here are a few examples to help with classification:

  • A compact standard machine with only one control system and a few sensor/actuator assemblies could theoretically be considered a complex component. However, the IEC 62443-4-2 requirements for components only apply to a limited extent here, as they typically apply to individual devices (e.g. requirements for a single control system or communication device). However, the machine consists of several components and fulfils a function as a whole.
  • Many machines – especially more complex production machines or plant modules – are better understood as stand-alone systems. They often have an internal network, multiple control units, operating stations, etc., and are essentially small automation systems. The technical system requirements from IEC 62443-3-3 would be more relevant here, as they cover security aspects of an entire solution (e.g. user management, logging, network segmentation, whitelisting, etc.). In practice, however, it has been shown that not all requirements of IEC 62443-3-3 can be applied directly to a single machine on a one-to-one basis. For this purpose, IEC 62443-3-3 (as well as IEC 62443-4-2) provides for the concept of ‘compensating countermeasures’. This concept allows external measures to be used to fulfil the requirements for the system/product in justifiable cases. From this perspective, requirements of IEC 62443-3-3, such as the requirement for centralised user management or shared log servers for the entire system at higher security levels – provided that an isolated machine may not be able to or required to provide these functions in full – can also be met by an external service (e.g. a higher-level system) via an interface.
     

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4. Conclusion

IEC 62443 does not explicitly address machine builders, and there are grey areas. Depending on the scenario, a machine manufacturer can therefore act as both a manufacturer and an integrator – and its machine can be viewed as both a product and a system. In case of doubt, however, the classification tends to lean towards the system perspective. A machine consists of several IACS components and behaves like a small industrial automation system, so that consideration in accordance with IEC 62443-3-3 (system requirements) is obvious. For the machine manufacturer, this means that they should provide system-wide security functions wherever possible (e.g. user and rights management, network segmentation within the machine, hardening of all embedded components, etc.), as required for an IACS system. At the same time, they must also ensure that the individual components installed (controllers, HMIs, routers, etc.) have sufficient security features – ideally developed in accordance with IEC 62443-4-2 or similar standards.

From a process perspective, the applicable IEC 62443 standards depend on the type of business. A manufacturer who develops products and manufactures them in series should above all establish a secure development process in accordance with IEC 62443-4-1. An integrator/plant manufacturer who designs customer-specific projects should rather take into account the requirements for secure integration services in accordance with IEC 62443-2-4. In reality, many mechanical engineering companies will wear both hats: special machine builders in particular need both a secure development process (IEC 62443-4-1) and competent integration practices (IEC 62443-2-4) to ensure security by design. Standard machine manufacturers will primarily implement the Secure Development Lifecycle (SDL) in accordance with IEC 62443-4-1, but can also benefit from integration guidelines – for example, when commissioning their machines at customer sites or offering services.
In order to meet the basic requirements of the Cyber Resilience Act, it remains to be seen which standards will be included by the EU Commission as harmonised EU standards in the Official Journal of the European Union in accordance with the Cyber Resilience Act or the Machinery Regulation. The latter in particular should then contain specific recommendations for action for regulated products, e.g. machines. Due to the broad acceptance of IEC 62443, it can be assumed that the EU standards will not reinvent the world of security, but will be based on the basic concepts of these standards.

For manufacturers of machinery, this means that, in the absence of harmonised EU standards, they will find it difficult to avoid dealing with the requirements of the respective parts of IEC 62443 in order to ensure that their product development is already at the state of the art (in terms of security). For the future of the standards landscape, it is to be hoped that the harmonised standards will be aligned with the legal requirements in order to leave behind the laborious and potentially costly interim situations that we are experiencing in mechanical engineering with regard to IEC 62443 and that the convenience of appropriate harmonised standards, which is well known in the safety world but sometimes underestimated, will also find its way into practice as quickly as possible in the security sector.


Posted on: 2025-10-07

Authors

Florian Gerstmayer
Graduate of the University of Applied Sciences Technikum Wien (degree programmes: Electronics, Embedded Systems Engineering and Innovation & Technology Management). He worked for several years in project development as a software developer, project manager and product security officer, performing risk analyses, developing security concepts and implementing measures. Today, he is responsible for Product & Solution Security Consulting at Limes Security. He and his team advise on upcoming regulations (CRA, MVO, RED, etc.) and the IEC 62443 series of standards and carry out threat analyses.

E-Mail: fge@limessecurity.com | www.limessecurity.com

Johannes Windeler-Frick, MSc ETH
Member of the IBF management board. Specialist in CE marking and Safexpert. Presentations, podcasts and publications on various CE topics, in particular CE organisation and efficient CE management. Management of the further development of the Safexpert software system. Degree in electrical engineering from ETH Zurich (MSc) with a focus on energy technology and specialisation in the field of machine tools.

Email: johannes.windeler-frick@ibf-solutions.com | www.ibf-solutions.com

 


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