What CE Marking Actually Requires From an Engineering Team

CE marking is often treated as an administrative step at the end of a machine development project. It is easy to assume that once the equipment has been designed and manufactured, the remaining work is simply to prepare the documentation and attach the CE mark.

In practice, the documentation is only the visible result of a much larger process. Before a manufacturer can declare that a machine complies with the applicable European requirements, its design, safety functions, electrical systems, and operating instructions must all be evaluated. The engineering work behind that declaration is what makes CE marking more than a paperwork exercise.

For manufacturers, this means that conformity requirements need to be considered throughout the development process, rather than addressed only when the machine is almost ready for delivery.

What Does CE Marking Actually Mean?

CE marking indicates that a product meets the applicable EU legislation governing its design, manufacture, and safety. For industrial machinery, the relevant framework currently includes the Machinery Directive 2006/42/EC. Depending on the equipment, other legislation may also apply, including requirements covering electrical equipment, electromagnetic compatibility, pressure equipment, or potentially explosive atmospheres.

It is important to identify the applicable legislation for each product rather than assume that every machine follows exactly the same conformity assessment route.

There is also an important regulatory change approaching. The Machinery Regulation (EU) 2023/1230 will replace the Machinery Directive from 20 January 2027. Manufacturers developing new equipment should therefore consider which requirements will apply when their machinery is placed on the market or put into service.

CE marking is not a general quality certificate issued by an external organization. In most cases, the manufacturer is responsible for carrying out or arranging the necessary conformity assessment, preparing the technical documentation, drawing up the Declaration of Conformity, and affixing the CE mark. A notified body must be involved only where the applicable legislation and conformity assessment procedure require it.

The Risk Assessment: Where Much of the Engineering Work Begins

One of the central elements of machinery safety is the risk assessment. It is not simply a checklist of potential hazards. It is a systematic process of identifying hazards, estimating and evaluating risks, and determining what measures are needed to reduce those risks.

The process is guided by EN ISO 12100, which provides principles for machinery risk assessment and risk reduction. It requires engineers to understand how the machine is designed, how it operates, who interacts with it, and what can happen during both normal operation and foreseeable abnormal situations.

The assessment needs to consider different categories of hazards, including:

• Mechanical hazards: moving parts, crushing and shearing points, rotating components, sharp edges, ejected materials, and unexpected machine movement.
• Electrical hazards: electric shock, short circuits, overheating, and faults in electrical equipment.
• Thermal hazards: hot surfaces, heated materials, and other sources of burns or temperature-related injuries.
• Ergonomic hazards: difficult access, awkward operating positions, repetitive tasks, and unsuitable control arrangements.
• Operational and maintenance hazards: risks arising during cleaning, adjustment, troubleshooting, repair, and other activities outside normal production.

Identifying a hazard is only the first step. Engineers must also evaluate the associated risk and determine how it can be reduced. The preferred approach is to address hazards through the design itself wherever possible. Where risks cannot be eliminated by design, safeguarding measures and protective devices are considered. Information for use, including warnings and instructions, supports the remaining risk reduction but should not replace appropriate design and protective measures.

The quality of this assessment depends on how well the engineering team understands the actual machine. A formal document may contain all the expected sections, but it is useful only if the hazards and proposed protective measures reflect the equipment’s real configuration and operating conditions.

Safety Functions and Performance Levels

Many industrial machines rely on safety-related control functions to prevent dangerous situations. These may include emergency stop systems, guard interlocking, two-hand controls, light curtains, and other protective devices.

However, installing a safety component does not automatically make the machine safe. The complete safety function must be designed and evaluated to achieve the required level of risk reduction.

EN ISO 13849-1 provides a framework for designing and evaluating safety-related parts of control systems. One of its key concepts is the Performance Level (PL), which describes the ability of a safety-related control system to perform a required safety function under specified conditions.

The engineering process generally involves several steps:

1. Determine the required Performance Level (PLr). The risk assessment establishes the level of risk reduction required from each safety function.
2. Select an appropriate system architecture. Engineers consider the structure of the safety-related control system, including channels, redundancy, and diagnostic measures.
3. Select suitable components. Sensors, logic units, safety relays, and actuators must be appropriate for the required function and its operating conditions.
4. Evaluate the achieved Performance Level. The system is assessed using relevant parameters, including component reliability data, diagnostic coverage, and common-cause failure measures.
5. Validate and document the function. The design must be checked against the specified requirements, and the results recorded in a form that supports the overall conformity assessment.

Tools such as SISTEMA can support the calculation and documentation of Performance Levels under EN ISO 13849. They help engineers evaluate the architecture and component data, but they do not replace the need for correct system design, suitable input data, and validation.

The required Performance Level is not the same for every safety function. It must be determined from the risk assessment, and the achieved level must meet or exceed that requirement.

Electrical Design, PLC Programming, and Technical Documentation

Machinery safety is not limited to mechanical guarding. Electrical and control systems play an equally important role in preventing hazardous situations and ensuring that protective functions behave as intended.

Electrical documentation must accurately represent the actual machine. This includes circuit diagrams, component information, protective devices, control arrangements, and relevant safety-related connections. Where the electrical design changes during development or commissioning, the documentation must be updated accordingly.

Safety-related PLC programming also requires particular attention. The logic responsible for emergency stops, guard monitoring, safe stopping, and other protective functions must correspond to the safety requirements established during the risk assessment. The implementation must be tested and validated to confirm that the intended safety behaviour is achieved.

Operating instructions are another essential part of the technical documentation. They should explain the machine’s intended use, operating procedures, installation requirements where relevant, maintenance, and foreseeable misuse. They must provide users with the information necessary to operate and maintain the equipment safely.

The technical file brings the evidence together. Depending on the applicable legislation and the type of machinery, it can include:

• Risk assessment and the measures implemented to reduce identified risks.
• Design and manufacturing drawings, diagrams, and relevant calculations.
• Information about safety-related control systems and their validation.
• Applicable standards and technical specifications.
• Test results and other evidence supporting conformity.
• Operating and maintenance instructions.
• The relevant Declaration of Conformity and supporting documentation.

The documentation must be consistent with the machine that is actually manufactured. A technical file based on an earlier design version, for example, may no longer provide an accurate picture of the equipment after modifications have been made.

Why CE Marking Should Start During Machine Development

Leaving conformity work until the end of a project can create expensive problems. If a risk assessment identifies an insufficient protective measure after the machine has been manufactured, the solution may require changes to the mechanical design, electrical architecture, control software, or physical layout.

These modifications can affect several engineering disciplines at once. A new guard may require changes to the frame. A different safety sensor may affect electrical drawings and PLC programming. A revised safety function may require new calculations, validation, and documentation.

When safety requirements are considered from the beginning, they can be incorporated into the design decisions that shape the machine. This makes it easier to coordinate mechanical engineering, electrical design, automation, and documentation while reducing the likelihood of major changes late in the project.

The same principle applies to engineering changes during production. When a component, control function, or machine configuration is modified, the relevant risk assessment and technical documentation should be reviewed to determine whether the change affects conformity.

How GFE Solutions Supports CE Marking Projects

At GFE Solutions, we support manufacturers with the engineering activities that contribute to machinery conformity assessment. Our work covers several areas that need to come together before a machine is ready for the market.

Our support can include:

• Risk assessment: identifying machinery hazards, evaluating risks, and documenting the measures required for risk reduction in accordance with EN ISO 12100.
• Safety function design: developing safety-related control solutions and determining the required Performance Levels.
• PLC safety programming: implementing safety-related control logic in accordance with the defined requirements.
• SISTEMA documentation: evaluating safety functions and documenting achieved Performance Levels using SISTEMA or equivalent engineering tools.
• Technical file preparation: organizing engineering documentation, calculations, diagrams, and supporting information required for the conformity assessment process.

Our engineers can work within the client’s existing engineering environment, using established software, internal standards, and documentation procedures. This makes it possible to coordinate work across mechanical design, automation, and technical documentation without treating CE marking as a separate administrative task disconnected from the machine’s development.

The manufacturer remains responsible for the overall conformity assessment, the Declaration of Conformity, and the decision to affix the CE mark. Where a notified body is required, its involvement must follow the applicable conformity assessment procedure. GFE’s role is to provide the engineering work and documentation that support this process.

CE Marking Is an Engineering Responsibility

A CE mark represents the outcome of a process that begins long before the final machine is delivered. Risk assessment, safety functions, electrical design, control programming, testing, and technical documentation all contribute to demonstrating that the equipment meets the applicable requirements.

For manufacturers, the most effective approach is to involve the relevant engineering disciplines early and keep conformity requirements connected to the actual design throughout the project.

GFE Solutions supports industrial companies with the engineering capacity needed to complete these activities, from risk assessment and safety-related control systems to technical file preparation. If your team is developing a new machine or preparing existing equipment for the European market, we can discuss the engineering scope and the support required.