Formative evaluation during design and implementation, with results stored in the usability engineering file and a feedback loop to repeat earlier Clause 5 steps when new use errors or hazards are discovered.
AMD1:2020 added an explicit training capability obligation: if training is required for safe use, the manufacturer must design and maintain that training capability for the expected service life of the device.
Formative evaluation records in the usability engineering file and evidence of the Clause 5 feedback loop — undocumented evaluation sessions and unresolved findings are the most common clause 5.8 findings.
Maps to
IEC 62366: §5.8 Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION
ISO 13485: §7.3.4 Design and development outputs
Requirement text
The manufacturer shall design and implement the user interface, including the accompanying documentation if needed, and training capability if needed, as described in the user interface specification. The manufacturer shall utilize, as appropriate, usability engineering methods and techniques, including formative evaluation, to accomplish this design and implementation. The results of any utilized formative evaluation shall be stored in the usability engineering file. Where new use errors, hazards, hazardous situations, or hazard-related use scenarios are discovered during this step, the manufacturer shall repeat the steps of Clause 5 as appropriate. If training on the specific medical device is required for the safe use of the medical device by the intended user, the manufacturer shall design and implement a training capability for the expected service life of the medical device by doing at least one of the following: provide the materials necessary for training; ensure that the materials necessary for training are available; make the training available; or make training available to the responsible organization that enables it to train its users.
Why this clause exists
Clause 5.8 exists because the design and implementation phase is where usability engineering obligations shift from analysis and planning to active risk control — and because formative evaluation during this phase is the mechanism that catches hazardous interface designs before they advance to the final device and require costly redesign or, worse, reach the market. The formative evaluation obligation is specifically structured as iterative: results must be stored in the usability engineering file, and any newly discovered use errors or hazardous situations must trigger a return to earlier steps of Clause 5. This iterative architecture reflects the empirical fact that use errors in complex interfaces cannot be fully predicted analytically — they are discovered when users interact with progressively higher-fidelity prototypes. Regulatory agencies have documented cases where hazardous use-error patterns that were not predicted in the use-error analysis were first observed during formative evaluation of a working prototype, allowing the manufacturer to implement a design fix before the interface was locked. The training capability obligation at clause 5.8 exists because training is only a permissible risk control under clause 4.1.2(c) if the training is actually available to users for the device’s service life — and the obligation to design and maintain a training capability ensures the manufacturer does not treat training as a one-time activity that degrades over the product lifecycle.
What changed
IEC 62366-1:2015+AMD1:2020 CSV clause 5.8 was meaningfully expanded by AMD1:2020. The 2015 edition required design and implementation per the UI specification and formative evaluation with results stored in the usability engineering file. AMD1:2020 added the explicit training capability obligation: if training is required for safe use, the manufacturer must design and implement a training capability for the expected service life of the device and ensure it is available to users or the responsible organization. This extends the manufacturer’s obligation beyond delivering a training document at launch to maintaining a training capability throughout the device lifecycle. AMD1:2020 also updated ISO 14971 cross-references (from 2007 §6.6 to 2019 §7.5 for the design-change review obligation noted in the informative notes).
Common gaps (what we see in audits)
- Formative evaluation results not documented in the usability engineering file — Teams conduct formative evaluation activities — design reviews, user testing sessions, expert critiques — without producing documented reports stored in the usability engineering file. Verbal design feedback sessions and informal whiteboard reviews do not constitute usability engineering file records. Without documented formative results, there is no evidence that clause 5.8’s iterative evaluation obligation was satisfied.
- Training capability not maintained for the expected service life — AMD1:2020 requires a training capability for the expected service life, not just at initial release. Manufacturers that deliver training materials at launch without a plan for maintaining, updating, and distributing training when the interface changes — or when the responsible organization’s user base changes — do not satisfy the clause 5.8 obligation.
- Formative evaluation findings not fed back into Clause 5 risk analysis — New use errors or hazardous situations identified during formative evaluation are addressed as design problems — the interface is fixed — without updating the use-error analysis (clause 5.2), hazard identification (clause 5.3), and hazard-related use scenarios (clause 5.4) to reflect the newly discovered failure modes. The risk management file and hazard-related use scenarios list remain based on pre-formative-evaluation knowledge, creating a traceability gap.