How do you demonstrate the usability of your medical device under IEC 62366-1 in an audit-ready way for the notified body?
We build the usability engineering process to IEC 62366-1 into your development from day one: the use specification, the analysis of hazard-related use scenarios, formative evaluation and summative validation all feed into an audit-ready usability engineering file. The real stumbling block is rarely the summative study itself, but the sequence leading up to it. If you do not derive the hazard-related use scenarios from your risk management under ISO 14971, you end up validating the wrong tasks and have to repeat the study.
- MedTech
- IVD
Overview
What requirements does IEC 62366-1 place on manufacturers?
Usability support for MedTech and IVD · IEC 62366-1:2015, ISO 14971, MDR (EU 2017/745)
Last updated: 2026-06-13
IEC 62366-1:2015 does not call for a one-off usability test at the end, but for an end-to-end process that systematically addresses use errors as a source of hazard. The four points where usability files most often fail during the notified body review:
- Usability is bolted on only towards the end of the project instead of being integrated into development from the outset. IEC 62366-1 assumes that the use specification and the hazard-related use scenarios drive the design rather than confirming it after the fact.
- The hazard-related use scenarios are not derived from risk management under ISO 14971. The two standards interlock: use errors are a hazard source within the risk analysis, and it is precisely these critical scenarios that define the scope of the summative validation.
- The summative evaluation is methodologically weak in its design and yields no robust data on use errors. Without representative user groups, a realistic use environment and pre-defined acceptance criteria, the validation is not meaningful.
- The usability results are not linked to the instructions for use (IFU) and the technical documentation under MDR (EU 2017/745) or IVDR (EU 2017/746). Risk mitigation through information for safety must be evidenced where the notified body looks for it.
Services
How we support you
Building the usability engineering process
Establishing the usability engineering process to IEC 62366-1: a use specification covering the intended purpose, user profiles, use environment and user interface. The deliverable is a documented use specification as the foundation of the usability engineering file.
Analysis of hazard-related use scenarios
Identifying use errors and deriving the hazard-related use scenarios from the risk analysis under ISO 14971. The deliverable is a prioritized list of the critical tasks to be validated, linked to the risk assessment.
Learn more →Formative evaluation & iterative testing
Conducting formative evaluations in the early development phases: prototype tests, expert reviews and cognitive walkthroughs with documented findings. The deliverable is a set of traceable design changes and a formative evaluation report.
Summative evaluation (validation study)
Planning and conducting the summative evaluation with representative users: test plan, use scenarios, acceptance criteria and analysis. The deliverable is a usability evaluation report that demonstrates the safety of the final design.
Usability engineering file & MDR integration
Building and reviewing the usability engineering file and linking the results to the IFU, risk management and technical documentation under MDR (EU 2017/745) or IVDR. The deliverable is an audit-ready, fully cross-referenced usability file.
Learn more →How we work together
What it comes down to
The standard IEC 62366-1:2015 treats use errors not as a secondary risk but as a hazard source in their own right, one that must be addressed in sequence. The starting point is the use specification with its intended purpose, user profiles and use environment. From it and the risk analysis under ISO 14971, the hazard-related use scenarios are derived, that is, exactly the tasks whose incorrect operation could lead to harm. These scenarios determine what the summative evaluation must test at the end. Anyone who reverses this chain and plans the study first ends up validating tasks that do not correspond to the highest risks, and has to retest if the notified body raises findings.
This is precisely where we come in: the formative evaluation takes place before the design freeze, while findings can still flow back into the design rather than merely being documented. The summative study only follows once the design is frozen and the acceptance criteria are fixed in advance. Finally, the results are fed back into the IFU, the risk file and the technical documentation under MDR (EU 2017/745), so that the risk mitigation through information for safety is evidenced where the notified body checks for it.
Our approach
Our approach
Step
Result
Use specification
A documented intended purpose, user profiles, use environment and user interface as the basis of the usability engineering file.
Hazard-related use scenarios
A list of use errors and critical use scenarios derived from ISO 14971 that sets the scope of the summative validation.
Formative evaluation
An iteratively improved design with documented findings and traceable design changes.
Summative evaluation
A completed validation study with representative users and a usability evaluation report against pre-defined acceptance criteria.
Usability engineering file
An audit-ready usability file cross-referenced with risk management, the IFU and the technical documentation for the notified body review.
Common pitfalls
Where projects commonly fail
Usability is not started until after the design freeze.
If the formative evaluation can no longer feed back into the design, the summative study merely documents existing weaknesses instead of preventing them. IEC 62366-1 requires an iterative process, not a final tick-box.
The hazard-related use scenarios are created independently of risk management under ISO 14971.
The summative study then validates tasks that do not correspond to the highest risks, and the critical use errors go untested. The notified body spots the missing link.
The summative study is run with non-representative users or in an unrealistic environment.
Results from a lab setting with no connection to the actual user group and application situation will not carry the usability evidence.
Pre-defined acceptance criteria for the summative evaluation are missing.
If success and the assessment of the observed use errors are only defined after the study, the analysis is open to challenge and provides no robust validation.
The usability results are not fed back into the IFU, the risk file and the technical documentation under MDR (EU 2017/745).
A self-consistent usability engineering file is of little use if the risk mitigation through the instructions for use is not evidenced in the risk management and the technical documentation.
FAQ
Frequently asked questions
Sources
- IEC 62366-1:2015: Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971: Application of risk management to medical devices
- Regulation (EU) 2017/745 (MDR): primary text, Annex I (general safety and performance requirements)
- Regulation (EU) 2017/746 (IVDR): primary text
- Entourage website-writer source material: usability-engineering.md
- https://theentourage.de/expertise/usability-engineering/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- IEC 62366-1:2015 (application of usability engineering to medical devices)
- ISO 14971 (application of risk management to medical devices)
- EU 2017/745 (MDR)
- EU 2017/746 (IVDR)
- IEC 62304 (software life cycle processes, where software is involved)
Related topics
Design Controls →
User needs and design inputs as the basis of the use specification
Risk Management →
Use errors as a hazard source under ISO 14971
Labeling & IFU Authoring →
Instructions for use as risk mitigation in the usability process
Verification and Validation →
Summative evaluation as part of design validation
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