Foreseeable Misuse: The Safety Concept Teams Underestimate

Product safety in the European Union is built upon a deceptively simple premise: that a product must be safe not only when used as intended by its manufacturer but also when used in a way that is reasonably foreseeable. For engineering teams working on complex systems—whether autonomous vehicles, medical robotics, AI-driven diagnostic tools, or industrial IoT—this concept of foreseeable misuse is often treated as a compliance checkbox, a vague requirement to be addressed late in the development cycle. This perspective is not only incorrect from a regulatory standpoint but also represents a significant engineering and liability risk. In the European regulatory landscape, understanding and engineering against foreseeable misuse is not an administrative burden; it is a core component of the essential health and safety requirements that underpin market access.

The failure to adequately address foreseeable misuse manifests in product recalls, enforcement actions by market surveillance authorities, and, in the worst cases, accidents that could have been prevented through better design. As systems become more autonomous and integrated into critical infrastructure, the vectors for misuse expand exponentially. The European Union’s legal framework, anchored in the New Legislative Framework (NLF), places the burden of proof squarely on the manufacturer to demonstrate that they have anticipated the unexpected. This article analyzes the legal definition of foreseeable misuse, explores the methodologies for anticipating it, and details the documentation practices required to satisfy the scrutiny of Notified Bodies and market surveillance authorities across the diverse regulatory landscape of the EU.

The Legal Anatomy of Foreseeable Misuse

To understand the practical implications of foreseeable misuse, one must first look to the primary legislation. While the term appears in various sector-specific regulations, its foundational definition is found in the General Product Safety Directive (GPSD) 2001/95/EC, which is currently being replaced and strengthened by the General Product Safety Regulation (GPSR) 2023/988. However, the concept is most rigorously applied in the context of the New Legislative Framework, specifically under Regulation (EU) 2019/1020 (the Market Surveillance and Compliance of Products Regulation).

Article 2(1) of the GPSR defines a “safe product” as one which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the use of the product and which are considered as acceptable and consistent with a high level of protection of health and safety.

The critical phrase here is reasonably foreseeable conditions of use. This is not a subjective assessment. It requires the manufacturer to look at the product through the lens of the end-user, the installer, the maintainer, and even the bystander. The European Court of Justice has interpreted this broadly. It is not limited to the “correct” use or even the “incorrect” use that a rational person would avoid. It encompasses:

• Misapplication: Using the product for a purpose other than that intended (e.g., using a consumer drone to transport hazardous materials).
• Misunderstanding: Failing to perceive a risk due to poor interface design or inadequate warnings (e.g., a surgeon misinterpreting an AI confidence score).
• Bypassing Safety Features: Deliberately disabling guards or software locks to increase efficiency or convenience (e.g., overriding safety interlocks on an industrial robot).

It is vital to distinguish between foreseeable misuse and unforeseeable misuse. If a user acts in a manner that is irrational, bizarre, or contrary to all available instructions and warnings, the manufacturer may not be held liable. However, the bar for proving something is “unforeseeable” is extremely high. Market surveillance authorities operate on the assumption that if a misuse has occurred once, it was likely foreseeable. The burden is on the manufacturer to prove that they could not have reasonably anticipated it.

The Intersection with CE Marking and Essential Requirements

Foreseeable misuse is not a standalone concept; it is woven into the fabric of the Essential Health and Safety Requirements (EHSRs) found in almost all EU harmonization legislation, such as the Machinery Directive (2006/42/EC), the Medical Device Regulation (2017/745), and the AI Act (2024/1689).

Consider the Machinery Directive. Annex I, Section 1.1.2(b) explicitly states that machinery must be designed and constructed in such a way as to prevent risks from foreseeable misuse. This is a mandatory requirement. To obtain the CE mark, a manufacturer must justify in the Technical File that the machinery is safe against such misuse. If a robotic arm can be easily accessed for maintenance while powered on, and a worker is injured, the manufacturer has failed the EHSR regarding “foreseeable misuse,” regardless of whether the worker violated a safety manual.

In the context of the AI Act, the concept is implicit but pervasive. The requirement for “human oversight” (Article 14) is essentially a mitigation against the foreseeable misuse of AI systems—specifically, the misuse of automation where human judgment is required. If an AI system is designed in a way that encourages “automation bias” (where users blindly trust the system), it facilitates foreseeable misuse. The regulatory expectation is that the system is designed to resist, not encourage, such misuse.

Anticipating the Unintended: Methodologies for Engineering Teams

How does an engineering team move from a legal concept to a technical reality? The process requires a shift in mindset from “does it work?” to “how can it be broken?” This is best achieved through the integration of Foreseeable Misuse Analysis (FMA) into the risk management system, typically aligned with ISO 14971 for medical devices or ISO 12100 for machinery.

Scenario Mapping and User Profiling

The starting point is the identification of “reasonably foreseeable” user groups. This goes beyond the “intended user.” It includes:

1. The Novice: Someone with no training or minimal training.
2. The Expert: Someone who has developed “workarounds” to save time, potentially bypassing safety steps.
3. The Child/Unauthorized User: Particularly relevant for consumer products or smart home devices.
4. The Maintainer: Someone servicing the device who may be exposed to residual energy or unexpected startup.

For each profile, teams should conduct “negative scenario planning.” Instead of asking “What happens if the user does X?”, ask “What is the most likely error a user could make in this state?” For example, in a software interface, is the “Emergency Stop” button visually distinct from the “Pause” button? If a user confuses them during a crisis, that is a foreseeable misuse.

Utilizing Failure Modes and Effects Analysis (FMEA)

Standard FMEA focuses on component failure. To address misuse, teams should adapt this to Use-Related FMEA. This involves:

• Step 1: List every user interaction with the device.
• Step 2: Identify potential errors for each step (e.g., wrong button press, wrong sequence, wrong tool used).
• Step 3: Determine the severity of the potential harm.
• Step 4: Evaluate current controls (software interlocks, physical guards, warnings) and assess if they are sufficient to reduce the risk to acceptable levels.

If the risk remains high, the design must be changed. Relying solely on warnings is rarely sufficient for high-severity risks. The hierarchy of controls (intrinsic safety by design) is the regulatory preference.

The Role of Human Factors and Usability Engineering

Usability engineering (often associated with IEC 62366-1) is the practical tool for mitigating foreseeable misuse. A product that is difficult to use correctly is a product that invites misuse. If a user has to consult a manual three times to perform a basic function, they will eventually stop consulting the manual and improvise.

Regulatory auditors look for evidence of usability testing that includes “error recovery.” It is not enough to test if users can perform the correct task; you must test how they handle incorrect inputs. Does the system fail safe? Does it provide clear feedback on the error so the user understands what they did wrong and how to correct it without creating a new hazard?

Documentation: The Evidence of Diligence

In the EU regulatory system, if it isn’t documented, it didn’t happen. The Technical File is the legal defense of the manufacturer. When it comes to foreseeable misuse, the documentation must be robust and traceable.

The Technical File and the Declaration of Conformity

The Technical File must contain a dedicated section on risk assessment that explicitly addresses foreseeable misuse. This section should include:

• The List of Foreseeable Misuses: A comprehensive inventory derived from risk analysis, literature review, and incident data.
• The Hazard Analysis: For each misuse, identify the associated hazards (e.g., crushing, electrocution, misdiagnosis).
• The Mitigation Measures: Detailed description of the technical and organizational measures taken to eliminate or reduce these risks. This includes software logic, hardware interlocks, and labeling.
• The Residual Risk Evaluation: An assessment of whether the remaining risk is acceptable. If not, the product cannot be CE marked.

The Declaration of Conformity (DoC) must reference the applicable legislation and standards. While the DoC itself is a short document, it is a legally binding statement that the manufacturer has complied with all essential requirements, including those regarding foreseeable misuse.

Instructions for Use (IFU) and Labeling

While engineering controls are primary, the IFU is a secondary layer of defense. However, the IFU must not be used to offload responsibility. A warning like “Do not use underwater” is useless if the device is marketed for outdoor use in rainy climates without IP-rated protection.

Effective IFUs for foreseeable misuse mitigation should:

1. Explicitly state what the product is not intended for.
2. Use pictograms to transcend language barriers (essential for the Single Market).
3. Highlight “Do Not” scenarios with high-contrast visual cues.

Market surveillance authorities frequently test products against their own labeling. If a product fails a safety test because a user could not reasonably understand the warning, the manufacturer is non-compliant.

Regulatory Divergence and National Nuances

While the EU strives for harmonization, the interpretation of “reasonably foreseeable” can vary between Member States. This is where the “New Legislative Framework” attempts to standardize enforcement, but national traditions persist.

The German vs. Anglo-Saxon Approach

Germany, with its strong engineering heritage and the influence of the German Institute for Standardization (DIN), often takes a rigorous, deterministic approach. The German market surveillance authorities (such as the Gewerbeaufsichtsamt) are known for scrutinizing technical safeguards. If a misuse is theoretically possible and a technical guard could have prevented it, they will likely flag it as non-compliance. They emphasize intrinsic safety.

In contrast, some Anglo-Saxon jurisdictions (influencing UKCA and sometimes CE market surveillance) have historically placed slightly more weight on the adequacy of warnings and user training, provided the risk is clearly communicated. However, under the GPSR and the NLF, this gap is narrowing. The EU trend is firmly toward requiring engineering solutions over labeling solutions for high-risk scenarios.

Biotech and Medical Devices: A High-Stakes Arena

In the medical field, the concept of misuse is critical. The Medical Device Regulation (MDR) requires manufacturers to consider “reasonably foreseeable misuse” in the clinical evaluation and risk management processes.

Consider a robotic surgery system. A foreseeable misuse might be a surgeon using the system for a procedure not explicitly cleared in the labeling, but for which the system is technically capable. The manufacturer must assess: Is this use likely? If so, does the system fail safe? Does it prevent the movement? Or does it allow it, potentially causing harm?

Post-market surveillance (PMS) data is crucial here. If a manufacturer sees a trend of surgeons using a device off-label in a specific way, they are legally obligated to update their risk assessment and potentially issue a Field Safety Corrective Action (FSCA). Ignoring these trends because they constitute “misuse” is a violation of MDR Article 83.

The AI Act and the Future of Software Misuse

The recently adopted AI Act introduces a new dimension to foreseeable misuse, particularly for high-risk AI systems. The regulation mandates that high-risk AI systems be designed to enable human oversight (Article 14). This is a direct response to the foreseeable misuse of automation: automation bias and deskilling.

Human Oversight as a Misuse Mitigation

The AI Act requires that the system allows the human supervisor to intervene or to ignore the output. This implies that the system must be designed to prevent the user from blindly following a recommendation that is erroneous or biased. If the interface design makes it difficult to override the AI, or if it hides the confidence score, the manufacturer is failing to mitigate foreseeable misuse (blind trust).

Furthermore, the AI Act requires robust data governance. If a dataset is trained on data that reflects historical biases, the resulting AI system will likely produce discriminatory outputs. While this is technically a “foreseen” risk based on the data, the Act treats the mitigation of this bias as a mandatory requirement. The “misuse” here is the deployment of a biased system, and the mitigation is the rigorous testing and auditing of training data.

General Purpose AI and the Open World Problem

For General Purpose AI (GPAI) models, the challenge of foreseeable misuse is magnified. Once a model is released into the wild, developers cannot predict every application. However, the AI Act requires providers of GPAI models to put in place a policy to comply with EU copyright law and to publish a summary of the content used for training.

More importantly, for models deemed to present “systemic risks,” there is an obligation to perform model evaluations and adversarial testing to identify potential vulnerabilities. This is essentially a hunt for foreseeable misuse scenarios (e.g., generating malware, creating deepfakes for disinformation). The mitigation is not just technical (patching the model) but procedural (cooperating with the European AI Office).

Practical Steps for Compliance Teams

To operationalize the management of foreseeable misuse, organizations should integrate the following steps into their Quality Management Systems (QMS).

1. Establish a “Misuse Register”

Do not bury misuse analysis in generic risk files. Create a specific register that tracks foreseeable misuse scenarios. This register should be a living document, fed by:

• Internal Expert Review: Workshops with engineers, designers, and safety experts.
• User Research: Observational studies of how users actually interact with prototypes.
• Competitor Analysis: Reviewing incident reports involving similar products.
• Help Desk Data: Analyzing customer complaints and questions for hints at confusion or misuse.

2. Implement “Safety by Design” Reviews

During the design phase, hold specific gate reviews focused on misuse. Ask the team: “If a user tries to do X, what happens?” If the answer is “It breaks” or “It hurts someone,” the design is not ready. This requires a culture where safety engineers have veto power over product managers who might want to prioritize convenience over safety.

3. Validate Against Misuse

Validation and verification (V&V) protocols must include test cases for foreseeable misuse. This is often called “abuse testing.” For software, this means fuzz testing and negative testing. For hardware, it means physical stress testing with improper tools or configurations.

When conducting clinical investigations or market research for medical devices, include scenarios where the device is used slightly outside the intended indication to see how the system and the user react.

4. Train the Supply Chain

Foreseeable misuse isn’t limited to the end-user. It applies to distributors, transporters, and installers. If a device is damaged during shipping because it wasn’t packed correctly (a foreseeable event), the manufacturer may be liable. Your technical documentation must include packaging specifications that mitigate these risks.

Conclusion: From Compliance to Resilience

Foreseeable misuse is often viewed as a trap set by regulators. In reality, it is a design philosophy that leads to more resilient, robust, and ultimately better products. By rigorously analyzing how a product can be misused, engineering teams uncover edge cases and failure modes that would otherwise lead to field failures and liability.

The European regulatory landscape is shifting toward a holistic view of product safety. The lines between physical products and software are blurring, and the concept of misuse is expanding to include data misuse, algorithmic bias, and automation over-reliance. For professionals working in AI, robotics, and biotech, the message is clear: safety engineering must account for the user who is distracted, the operator who is rushing, and the system that is pushed beyond its limits. If you can foresee it, you can prevent it. If you fail to foresee it, the EU regulatory framework will hold you accountable.