Metecon supports you in setting up usability engineering in accordance with IEC 62366-1 so that the context of use, use-related risks, user requirements, and development work together consistently—usability engineering with logical traceability throughout the entire product life cycle. From the use specification to the summative evaluation, we guide you every step of the way—for medical devices and in-vitro diagnostic medical devices.
10+ years of IEC 62366-1 expertise · Medical Devices MDR · In-Vitro Diagnostics IVDRUsability engineering helps to systematically identify and assess user-related risks and reduce them through safe interface design. IEC 62366-1 describes the internationally recognized process for this purpose.
Our USP: Usability with transparent traceability—product design, product safety, and usability consistently integrated.
What this means for you in concrete terms and how Metecon supports you in this regard:
If you don’t begin your usability activities until shortly before approval, they will lead to delays in the approval of the medical device, since usability aspects—as late-stage requirements—may need to be incorporated into the product design.
Metecon works with you starting in the development phase and plans your activities across the entire product life cycle.
If use-related risks are not consistently incorporated into your risk management and development decisions, your product will not meet regulatory requirements.
Metecon seamlessly integrates usability activities, risk management, and development for you—with end-to-end traceability.
If results from formative and summative activities are not consistently incorporated into development and documentation, knowledge is lost.
Metecon provides tailored support to help all stakeholders implement regulatory requirements.
A characteristic of the user interface that enables its intended users to achieve their goals effectively, efficiently, and with the required level of satisfaction within the specified usage environment.
IEC 62366-1 requires that use-related risks be systematically identified, assessed, and controlled. This includes, in particular, addressing use errors and use scenarios in which the design of the user interface or the use context may contribute to misuse.
A use error is an action or omission during use that leads to a result different from that intended by the manufacturer or expected by the user, and that may thus contribute to a hazardous situation.
IEC 62366-1 and ISO 14971 focus on the systematic management of use-related risks through the design of the user interface and the provision of appropriate safety information, taking into account the context of use and foreseeable misuse.
The use specification according to IEC 62366-1 §5.1 begins with a precise description of use, the use environment, and user groups. Reviews often reveal that when only the “operator” is considered, safety-related interactions involving preparation, installation, cleaning, maintenance, or administration are overlooked. This is precisely where gaps arise in critical tasks, use scenarios, and use-related risks—and thus lead to follow-up questions in the usability file. Metecon helps counteract the sometimes unavoidable “operational blindness” in this area, thereby ensuring a more practical and comprehensive assessment of usability.
Personas as a Method for Further Characterizing Product Users: To make user profiles more accessible in regulatory work, Metecon develops a persona for each user profile. Naturally, care is taken to ensure that, in addition to the primary users, supporting roles are also taken into account in both the personas and the user profiles.
The usability documentation can be structured in such a way that requirements from IEC 62366-1 and FDA Human Factors Engineering are clearly reflected. However, country-specific considerations regarding applicability may need to be incorporated as necessary.
Available as individual add-ons or as ongoing support throughout the entire usability process—tailored to your project’s current stage.
Structured documentation of usability in accordance with IEC 62366-1, including the use specification, risk identification, and formative and summative results.
Evaluation of usability aspects in risk analysis, including the presentation of results in risk management and usability documentation in compliance with regulatory requirements.
Assessment of user interfaces throughout the development process through formative evaluation (e.g., by supporting and documenting expert reviews or formative usability tests).
Planning and support for summative usability testing in accordance with IEC 62366-1, including test protocols, evaluation, and documentation of results.
Consideration of FDA HFE requirements when structuring performance documentation and summative evaluations, including country-specific considerations.
Use Specification, Usability Risk Assessment, and formative and summative evaluation in accordance with IEC 62366-1— for use-related safety and traceable usability documentation in accordance with the MDR.
MDR Annex I requires that risks associated with use be eliminated or minimized through appropriate product design. EN 62366-1 describes the recognized usability engineering process for this purpose.
Formative evaluation accompanies the development process and helps identify use-related issues early on.
The results are incorporated into the design of the user interface, use scenarios, and safety-related activities.
The summative evaluation uses a representative sample of users to determine whether safety-related tasks can be performed effectively on the final product under realistic conditions.
IEC 62366-1 does not specify a fixed number of subjects. What is crucial is that the relevant user groups, use contexts, and safety-related tasks are adequately represented. The data set generated in this way must make it possible to derive statistically significant conclusions regarding the product’s safety in its intended context of use.
Identified hazard-related use scenarios are justified (risk-based) and taken into account in the summative evaluation: use scenarios under realistic conditions, defining success criteria, and systematically recording use errors. Metecon prepares comprehensive test plans—compliant with IEC 62366-1 and FDA regulations.
Metecon assists with planning suitable test environments and coordinates external usability labs as needed. What matters most is a representative use context—not necessarily a certified lab space.
The results of the summative evaluation are documented in a transparent manner and prepared for inclusion in the usability documentation.
In risk management, the product’s risk context with regard to its use is examined from various perspectives. This approach is also reflected as such in the standard.
Identification of potential use errors, taking into account the product’s primary operating function. Here, user interface characteristics are typically first examined formally using a checklist to assess their potential impact on the product’s safety. Furthermore, these safety-related characteristics of the user interface are examined, together with the use specification, for potential use errors.
Identification of foreseeable hazards and hazardous situations related to the use of the product as part of the product’s risk analysis.
The identified hazard-related use scenarios are documented along with the associated tasks (including sequence), severity level, and associated harm. These hazard-related use scenarios are selected, with justification, for further investigation in a summative evaluation.
The usability documentation includes, among other things, the use specification, use errors, hazard-related use scenarios, results of formative evaluations, and the planning and results of the summative evaluation.
The goal is to provide a transparent overview of the usability engineering process in accordance with IEC 62366-1. Additional human factors requirements may be relevant for international target markets. Metecon assesses whether existing IEC 62366-1 documentation needs to be expanded to address these requirements.
For manufacturers with access to the U.S. market, FDA HFE requirements must also be taken into account.
The documentation can be structured in such a way that it consistently reflects both IEC 62366-1 and FDA Human Factors Engineering requirements.
For active electrical medical devices, IEC 60601-1-6 may also be relevant.
It refers to IEC 62366-1 and supports the usability assessment of electrical devices and user interfaces.
For software that is a medical device and for software embedded in a product, on-screen sequences, error messages, navigation, and user guidance contribute to the product’s risk.
IEC 62366-1 supports the assessment of software-based use scenarios and potential use errors.
IEC TR 62366-2 provides practical guidance and examples for implementing IEC 62366-1. Metecon uses this technical report, among other resources, as a guide for practical usability engineering documentation.
IVD place special demands on usability engineering: User profiles range from professional laboratory personnel to medical laypeople in near-patient testing (point-of-care, POC) and self-testing.
For IVDs used in point-of-care or self-testing settings, safety depends not only on the performance of the test, but also on whether users handle specimens correctly, follow the procedure, and interpret results accurately. For these user groups and usage contexts, use-related risks must be systematically identified and controlled. It is crucial that the user interface, information on safe use, and risk controls work together consistently and are documented in a traceable manner. Metecon translates your intended user groups and application scenarios into a robust use specification, derives critical tasks and use-related risks from it, and documents the evidence trail in a traceable manner in the usability file—coordinated with risk management and the instructions for use.
High-throughput analyzers and clinical laboratory systems: The focus is on multi-user scenarios, LIMS integration, and stable routine processes.
Point-of-care applications (near-patient testing) in emergency rooms, doctors’ offices, or nursing settings require clear operating procedures, robust user guidance, and easy-to-understand result presentation—often under time pressure.
IVD for self-testing are performed by laypersons without specialized medical training. Sample collection, test administration, and result interpretation must therefore be designed to be particularly clear and error-tolerant.
Point-of-care tests and devices for self-testing require a precise use specification: user groups, context of use, sample handling, and interpretation of results must be described realistically and taken into account in the evaluation. Metecon addresses this specific user profile as a separate use specification.
For self-testing devices, the target users, use situations, and typical limitations must be described realistically—such as use at home, limited experience, stress, or impaired motor skills. This results in relevant use scenarios for the evaluation.
Typical use errors regarding devices for self-testing involve sample collection, test administration, waiting times, or result interpretation. These use scenarios should be described in a structured manner in the UEF and addressed through appropriate interface and information design.
Summative evaluations for self-administered tests should reflect a representative sample of lay users and realistic use scenarios. Metecon provides support with test planning, defining user groups, and evaluating the results.
The specific ways in which users interact with the products must be taken into account in the use scenarios, such as continuous use of the product across shifts, during parallel work processes, and when user roles change.
Clinical laboratory systems have complex user profiles and use scenarios: routine operations, malfunctions, maintenance, shift changes, and multi-use scenarios.
Metecon develops use specifications that clearly map these use contexts and systematically document safety-related tasks.
Multi-user scenarios and shift changes affect operational procedures, responsibilities, and the handoff of information.
These use situations should be taken into account in use cases and evaluations.
For laboratory analyzers, data entry, result transmission, and error messages are particularly important.
Usability considerations should ensure that user guidance and feedback are clear and unambiguous.
Stefan Kemmann leads the Regulatory Affairs & Technical Documentation team at Metecon and has extensive expertise in usability engineering in accordance with IEC 62366-1. The usability experts at Metecon support manufacturers from the analysis of the usage environment through to summative evaluation, closely linking the usability process with risk management to ensure that the effort contributes effectively to the safety of the user-product interface.
"If you don’t factor in usability engineering during development, you’ll end up facing costly surprises. Through consistent risk management and by leveraging all available usability tools, we help you get a firm handle on the processes and documentation required for submission."
– Stefan Kemmann, Team Lead, Regulatory Affairs & Technical Documentation, Metecon
Those who correctly identify the context of use and application-specific risks early in the design and development phase and later can avoid costly redesigns shortly before approval. Formative activities uncover usability weaknesses during development, while changes can still be made cost-effectively. Metecon takes all regulatory requirements into account from the very beginning, ensuring that summative validation does not become a surprise at the end.
The key is to consistently link the use specification, risks, and supporting evidence. If these are clearly linked, it is possible to specifically assess which supporting evidence is affected when a change occurs—rather than having to collect everything from scratch. Metecon creates the usability file in a way that allows for updates, with traceability between risk management, requirements, and usability content.
Completeness alone is not enough: What matters is whether safety-critical tasks, application-specific risks, and findings from formative and summative evaluations are clearly linked. Where usability is not integrated with risk management, the Notified Body will raise questions. Metecon thoroughly examines precisely this soundness—not merely the presence of the documents.
Formative evaluation activities can often be conducted internally. External support is worthwhile when integrating usability aspects with risk management and during summative evaluation with representative users. Metecon provides support on an ad hoc or ongoing basis, including coordination of external usability labs, without requiring you to maintain your own infrastructure.
In that case, the final declaration regarding usability is open to challenge: The Notified Body cannot verify whether application-related risks are effectively controlled. This leads to additional inquiries and, in the worst case, to retesting. Metecon ensures end-to-end traceability between the summative evaluation and application-related risks.
Reports of errors when oprating the product during the market phase serve as the basis for the risk assessment and, if necessary, revisions regarding the product’s usability. Without clear traceability, the documentation and the actual product will drift apart. Metecon structures the usability file so that PMS and vigilance findings are incorporated in a structured manner.
A test is a one-time assessment; usability engineering is a continuous process that spans from the use specification through formative to summative evaluation—integrated with risk management. This is the only way to demonstrably manage risks associated with the product’s use. Metecon structures this very process in accordance with IEC 62366-1.
Key factors include the product’s risk class and safety in use, the number of user groups (e.g., trained professionals vs. laypeople), the scope of summative studies, and the target markets (e.g., MDR/IVDR and/or FDA, or other international markets). Metecon begins with a concise assessment and then provides a detailed proposal—the free initial consultation is the first step.
Risk Management
Risk Management According to ISO 14971 (UIAI Interface)
TechDoc
Technical Documentation for MDR & IVDR
V&V
Verification & Validation – Usability Interface
Software
Medical Device Software IEC 62304 & MDSW
Biological Safety
Biological Safety & Biocompatibility ISO 10993
PMS
Post-Market Surveillance: Safety in Use & Need for Adjustments Based on Market Experience
Digitalization
Digitalization of Regulatory Processes: Traceability & Change Management
QMS
QMS & ISO 13485 Auditing
Start with a free initial consultation, and we’ll provide you with a clear assessment—whether it’s a use specification, formative, or summative evaluation.
Your contact:
Milan Weiß
Sales Manager
T: +49 621 123469-040
milan.weiss@metecon.de
