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Tailoring the Usability Engineering Process according to IEC 62366-1

IEC-62366-1

IEC-62366-1

Tailoring the Usability Engineering Process according to IEC 62366-1

How much effort is actually required?

April 2025

Executive Summary

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This article examines how the usability engineering effort for medical devices can be appropriately adjusted to the specific situation without losing sight of the regulatory requirements. The international standard IEC 62366‑1:2015 specifies the requirements for the usability engineering process within the development of medical devices. Its focus is on reducing use errors that may result from inadequate usability and that could ultimately pose a risk to patients, users, or third parties. The standard is deliberately structured as a process‑oriented framework in order to accommodate different device types, risk levels, and development scopes. For this reason, the standard provides a certain degree of flexibility to tailor the extent of the usability engineering activities and adapt them to the respective development project.

The tailoring of the usability engineering effort is an integral and necessary aspect of applying IEC 62366‑1 to medical devices. It enables manufacturers to adapt the usability engineering process to the specific characteristics of the medical device, particularly its user interface, and its intended use. By considering factors such as the prevailing complexity of the user interface or the severity of potential harm related to use, a manufacturer can derive arguments to implement a tailored, efficient, and still comprehensively safe usability engineering process. How this can be carried out in practice is explained in detail in the present technical article.

1Objective of tailoring the usability engineering effort

Tailoring (adapting the extent of activities) serves the objective of conducting the usability engineering process in relation to the type of device, the risk level, and the use environment. Activities that are necessary for identifying and mitigating potential use errors must primarily be carried out in full depth. This allows the effort for documentation, analysis, and evaluation to be scaled efficiently without sacrificing essential insights.

By tailoring the usability engineering effort, the manufacturer gains the ability to customize certain activities. At the same time, the manufacturer remains responsible for ensuring that the existing safety requirements are met throughout medical device development. When implementing such a process adjustment, it is therefore essential to understand why the respective adaptation is permissible. Each adaptation should be supported with appropriate rationale and documented accordingly. The overarching objective remains the same: the development of safe and effective medical devices.

Tailoring process

2The basis for tailoring

Because medical devices and their user interfaces can vary significantly in terms of complexity, use environment, and potential risks, it is not always necessary or practical to apply the usability engineering process to the same extent for every device. IEC 62366‑1:2015 acknowledges this and permits tailoring of the usability engineering effort. The rationale behind this lies in the need to design the process flexibly so that it can be adapted to the specific characteristics of the medical device and its intended use. The regulatory basis for this is provided in Clause 4.3, “Tailoring of the usability engineering effort,” of IEC 62366‑1:2015, which explicitly addresses this possibility for adaptation.

3Which factors influence the tailoring and extent of the usability engineering activities?

In Clause 4.3 of IEC 62366‑1:2015, the standard identifies several factors that may be used to justify tailoring the usability engineering process effort within a given medical device development project. Both the level of effort and the selection of methods and tools used to carry out the usability engineering process can be adapted based on the following factors:

Extent and complexity of the user interface: The standard states that the extent and complexity of the user interface can serve as a basis for justifying the tailoring of the usability engineering effort. A more complex user interface typically requires a higher usability engineering effort to identify and mitigate relevant use errors than a simpler one. The terms “extent” and “complexity” can be interpreted in various ways and may include aspects such as heterogeneity or the number of interaction elements.

Severity of harm associated with the use of the medical device: This is based on the rationale that devices for which use errors may lead to severe harm should undergo a more intensive usability engineering process to minimize risks than devices with a potentially lower severity of harm. The primary inputs for this assessment are the severity definitions of the company’s internal risk matrix and the detailed analysis of the hazard‑related use scenarios.

Extent or complexity of the use specification: A broad or extensive variation in intended uses, users, or use environments indicates the need for a high usability engineering process effort, whereas a simple use specification with only one user group and a clearly defined use environment may justify a lower level of effort.

Presence of a user interface of unknown provenance (UOUP): If a medical device has a user interface of unknown provenance in accordance with the UOUP definition in IEC 62366‑1:2015 (Annex C), the significantly reduced usability engineering process described therein may be applied to reduce effort. Put simply, a UOUP refers to a user interface from an already developed medical device for which no sufficient records of the usability engineering process according to the current standard are available. However, it is essential to examine the situation carefully and verify that the conditions defined in the standard for applying the UOUP process are fully met before proceeding along this path.

Extent of modification to an existing user interface of a medical device that has already undergone the usability engineering process: For minor modifications to medical devices that have already been cleared in accordance with the usability engineering process, the usability engineering effort can be focused on the modified user interface elements and their impact on the use of the device. If the modifications do not affect the user interface or the Use Specification, no additional usability engineering effort may be necessary. The key question often is: Does the modification introduce new potential use errors that could lead to risks in a non‑acceptable region?

After the fundamental factors that can be used as a rationale for tailoring the usability engineering process have been outlined, the following section illustrates their application using practical examples.

4Practical application examples

To illustrate the previously outlined theoretical factors in practice, the following section compares two medical devices with very different user interfaces and use environments.

Bild 1 Vergleich Medizinprodukte 2

As an example of a medical device with a user interface that might justify a low usability engineering effort, a lancet for blood glucose measurement is used. Possible lines of argumentation may include the following aspects:

  • Low‑complexity user interface: It could be argued that the user interface of this manually operated lancing device for capillary blood sampling in individuals with diabetes typically consists of a mechanical release button and a simple depth adjustment via a rotating mechanism. In addition, the device contains no software components. Consequently, the human‑device interaction is limited to a few clearly defined steps.
  • Low assumed severity of harm: The analysis of identified hazard‑related use scenarios may indicate a low to medium severity of harm (e.g., minor injury without the need for medical treatment and a low risk of infection).
  • Low complexity of the use specification: It could be argued that the user profiles can be clearly defined and that users are generally familiar with the device.

In contrast, the assessment of an integrated anesthesia workstation with ventilation, monitoring, gas supply, and touchscreen control may lead to the conclusion that extensive usability engineering activities are necessary. This conclusion is based on the following points:

  • High‑complexity user interface: The medical device includes a wide range of user interface elements. These may include multiple display layers with touchscreen control, an alarm system, as well as numerical input functions.
  • High assumed severity of harm: The analysis of the hazard‑related use scenarios indicates severity levels in the high to critical range (e.g., related to lack of ventilation during induction of anesthesia or delays in life‑saving interventions) as a consequence of potential use errors.
  • High complexity of the use specification: The operation of this medical device is likely carried out by multiple user groups. The Use Specification may therefore include several intended user profiles, such as anesthesiologists, nursing staff, or technicians, which in turn may require configurable, highly individualized user profiles.

The brief comparison of these medical devices illustrates how differently the individual factors may be assessed. This, in turn, provides corresponding flexibility for tailoring the extent of the usability engineering effort.

5How should one proceed, and which activities can be tailored?

The standard and the associated technical report IEC TR 62366‑2:2016 indicate usability engineering process activities that must be carried out, whereas other activities allow for greater flexibility. In this context, we recommend the following approach.

Step 1 – Establish the decision basis

As mentioned at the beginning, safe medical device development is the central focus of the standard. To ensure this, the following essential foundational activities must first be carried out:

  1. The conceptual description of the user interface (user interface description) of the medical device, which includes the safety‑related user interface characteristics
  2. The creation of a use specification

  3. The execution of a use‑related risk analysis by means of:

    • Analysis of the available post‑production / post‑market information (with a focus on known use errors that may lead to use‑related risks)
    • Analysis of all hazard‑related use scenarios (with a focus on potential use errors that may lead to use‑related risks)

Ideally, this information is based on extensive user research activities as well as a well‑established internal data foundation regarding complaints and claims. This should be supplemented by a thorough review of relevant databases. In addition, the systematic identification of potential use errors as part of the development of the hazard‑related use scenarios is required.

Relevante Aktivitaeten zum Tailoring 1 scaled 1

Step 2 – Analyze the influencing factors

If comprehensive knowledge in the form of the user interface description, the use specification, and the use‑related risk analysis is available, a detailed analysis of the previously mentioned influencing factors can be carried out. This includes, for example, examining the complexity of the user interface and the Use Specification, as well as the assumed severity of harm.

Step 3 – Define and document the number and extent of the further usability engineering activities

Depending on the completeness and level of detail of the Use Specification as well as the known and potential use errors, the extent of the subsequent usability engineering activities is now defined. This includes in particular the further extent of

  • User research activities: The extent depends on the magnitude of existing gaps in the use specification, such as with respect to user groups, prevailing workflows, or use environment specifications.
  • User interface design iterations: Depending on the complexity, a few design cycles may be sufficient, or extensive iterative development cycles may be required. Design iterations should always be planned hand in hand with formative evaluations.
  • Formative evaluations: These are used to identify problems associated with the use of still‑immature user interfaces in order to conduct design optimizations based on the findings. The number and depth of these evaluations may vary and can be influenced to some extent (for example, through the choice of evaluation methods or the number of participating test users) and are often dependent on the extent and maturity of the available user interface prototypes.
  • Summative evaluation activity: This serves to provide objective evidence that the use‑related residual risk is at an acceptable level. The method most commonly applied here is the usability test. The scope of a summative evaluation is determined by the risks and the diversity of the hazard‑related use scenarios, as well as the associated user groups. If modifications to the user interface are required after the summative evaluation, additional evaluations may become necessary if the changes could introduce further use‑related risks. However, these can be focused on the affected interactions or interface elements.

Important – Keep the deliverable in mind: In particular, the definition of the number and extent of the formative usability evaluations to be conducted, as well as the methodology of the summative evaluation, should be documented in the user interface evaluation plan.

Conclusion

IEC 62366‑1:2015 enables a flexible and risk‑based approach to applying the usability engineering process. This is both reasonable and necessary to achieve an optimal balance of safety, effort, and product quality. Tailoring the usability engineering effort allows manufacturers to structure this process efficiently by adjusting its extent to the specific risks and the complexity of the product. Strategic tailoring—meaning a customized definition of the usability engineering activities—makes it possible to align regulatory compliance with economic efficiency within the development process. Take the time early in your development project to establish clarity in this regard, as it will save you significant effort and difficulties as the project progresses.

However, when tailoring the process, always ensure the consistency of your rationale in order to demonstrate compliance with the requirements of IEC 62366‑1:2015. A final remark: IEC 62366‑1 focuses strictly on applying the usability engineering process to optimize the usability of medical devices with respect to safety. More extensive usability activities may therefore not be regulatory requirements and may not be necessary to “get through” the process. However, such additional activities often lead to the user‑centered improvements that ultimately determine user satisfaction in daily practice and, consequently, the success or failure of your product.

Disclaimer

The information on standards and guidelines presented in this technical article has been prepared to the best of the author’s knowledge and expertise. It reflects solely the opinion of the author. No guarantee can be given with regard to the completeness, timeliness, or accuracy of the information provided. Standards and guidelines are subject to regular revisions and amendments, which may not always be immediately reflected here. This article does not constitute binding advice and does not replace a review of the applicable standards and guidelines by qualified experts or official bodies. For the application and interpretation of standards and guidelines, the currently valid original documents and the responsible organizations are authoritative.

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As usability engineering specialists, we at USE‑Ing. are pleased to support you in tailoring the usability engineering effort as part of your medical device development. Do you have any questions? Feel free to contact us.

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Usability requirements for medical devices on the Chinese market in accordance with NMPA

Header_NMPA

Header_NMPA

NMPA Usability Requirements for Medical Devices on the Chinese Market

What Manufacturers Need to Know

September 2025

Executive Summary

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Since October 8, 2024, the updated NMPA Usability & Human Factors Guideline has been in force. As part of medical device approval in China, it requires clear evidence that medical devices can be operated safely, taking into account Chinese cultural and linguistic conditions. This article explains which products are affected, which requirements apply, and how you can successfully meet them. In doing so, the recommended approach of our experts is explained in detail and illustrated using concrete examples.

1The Role of the NMPA in the Usability Approval Process

The responsible regulatory authority is the National Medical Products Administration (NMPA), the Chinese authority responsible for the regulation and supervision of pharmaceuticals, medical devices, and cosmetics. Since 2018, it has been the successor organization to the CFDA (China Food and Drug Administration) and is part of the State Administration for Market Regulation (SAMR). In the context of medical devices, the NMPA maintains various subordinate organizations and centers, including the CMDE (Center for Medical Device Evaluation).
The CMDE is a specialized unit within the NMPA that conducts the technical review and evaluation of registration and filing procedures for medical devices of all classes and is also responsible for usability. Similar to the U.S. FDA (Food and Drug Administration), the NMPA has defined its own usability requirements and published them in the form of guideline documents. The original Chinese documents can be downloaded here free of charge.
An expert group with substantial involvement of USE‑Ing. experts has prepared a commented English translation of the Chinese original text, which can be downloaded here free of charge.
NMPA Usability Engineering Anforderungen

2Which Products Does the NMPA Usability Guideline Apply To?

In principle, the NMPA Usability Guideline applies to medical devices of all classes. However, the Guideline requires the submission of usability documentation exclusively for Class II and Class III medical devices. In alignment with IEC 62366‑1:2015, the Guideline does not explicitly state that drug–device combination products fall within its scope of application. Nevertheless, based on various passages of the Guideline—particularly Section VI.(IV)—it can be assumed that the outlined principles also apply to all Class II and Class III medical devices that are part of, or constitute a component of, a product regulated as a drug. In‑vitro diagnostic reagents remain excluded from the scope of application.
It should be noted that the Chinese risk classification is not equivalent to the U.S. or European classification systems. However, this risk classification decisively determines the scope of usability activities to be conducted, in particular with regard to usability testing involving representative users. The following table presents the product catalogue included in the Guideline for products classified as high use‑risk from the perspective of the NMPA, for which summative usability testing is required under certain conditions (see Chapter 3).

Product Name

  • Cardiac radio-frequency ablation equipment
  • Cardiac radio-frequency ablation catheter
  • Radio-frequency ablation equipment for cardiac surgery
  • Radio-frequency ablation forceps/pen for cardiac surgery
  • Surgical navigation and positioning system (with robotic arm and end effector)
  • Endoscopic surgical system
  • Control system for vascular interventional surgery
  • Therapeutic ventilator
  • Home healthcare environment ventilator
  • External defibrillation equipment
  • Haemodialysis equipment
  • Continuous blood purification equipment
  • Artificial liver device
  • Implantable circulation assistance equipment
  • Implantable drug infusion equipment
  • Syringe pump (Class III)
  • Needle-free injectors
  • Infusion pump (Class III)
  • Insulin pump (Class III)

Table: Product catalogue for high use‑risk products – according to the NMPA Guideline (as of October 2024)

3Scope of Usability Activities and Documentation

The extent of usability engineering activities expected by the NMPA primarily depends on the following aspects:

  • The use‑risk level of the medical device
  • The availability of comparable equivalent medical devices that are already available on the Chinese market
  • The availability of human–machine interaction information for the identified equivalent medical devices

Depending on these variables, the NMPA expects the submission of one of the following two documents:

  • Use error evaluation report
  • Usability engineering research report

The following flowchart illustrates the recommended approach for determining the extent of usability engineering effort.

In the following, the individual steps are discussed in detail.

Step 1: Determination of the use‑risk level of the medical device

As an initial step, the use‑risk level of the product must be determined. In this context, the NMPA follows the established approach of both the FDA and IEC 62366‑1 by emphasizing that, due to the typically limited availability of data for risk classification, the focus should be placed on the severity of harm rather than on the probability of occurrence. In particular, the NMPA follows the approach of critical tasks, as already established by the FDA. In this regard, the NMPA defines the following:

  • Incorrect use of Class II medical devices (medium use‑risk) may result in minor injuries.
  • Incorrect use of Class III medical devices (high use‑risk) may result in serious injury or death. This concept is comparable to the FDA’s critical task approach.
According to the NMPA, the following characteristics are considered indicators of a high use‑risk product:
  • Completely new ways of use
  • Long learning curves
  • Use by lay users
  • High operational complexity
In addition, the use‑risk level of a medical device can also be determined based on post‑market surveillance data and recalls:
  • High use‑risk level: In the case of serious adverse events or Class I recalls related to use problems of similar medical devices after market launch.
  • Medium use‑risk level: In the case of adverse events or Class II recalls related to use problems of similar medical devices after market launch.
  • Low use‑risk level: If no adverse events have occurred, or only Class III recalls, or no recalls related to use problems of similar medical devices after market launch are present.
The assessment is substantively based on ISO 14971:2019. The outcome is a determination of whether a medical device is classified as having a high use‑risk level or not.
Step 2: Equivalent medical device comparative evaluation on the Chinese market If the medical device under development is not classified as a product with a high use‑risk level, the usability engineering process may be shortened and a use error evaluation report can be prepared directly.

However, if a product with a High Use‑Risk level is present, an equivalent medical device comparative evaluation on the Chinese market must be conducted. For this purpose, a systematic search shall be performed to determine whether equivalent medical devices are already available on the Chinese market. Relevant sources include, in particular, NMPA registrations and publicly available product information.

Define clear criteria to justify equivalence. These may, for example, include the following aspects:

  • alignment with respect to the intended use,
  • alignment with respect to intended user profiles,
  • alignment with respect to functional principles, and
  • alignment with respect to characteristic user interface (UI) features (controls, displays, and labels),

in combination with equivalent user tasks and workflows.

The search shall be documented in a traceable manner, including the search strategy, sources consulted, identified products, and the rationale for inclusion or exclusion. If an equivalent medical device exists in China, human–machine interaction data related to this device should be specifically collected and compiled, for example in the form of an equivalent medical device comparative evaluation report, which may form part of the usability engineering research report.
Step 3: Summative usability evaluation If no equivalent medical device can be demonstrated, validation is to be conducted in the form of a summative usability test. This may be carried out either in‑house or by an external usability testing service provider (agency or test laboratory). However, the NMPA clearly emphasizes that the individuals involved in conducting the evaluation must possess expertise in usability testing of medical products and devices, and that the evaluation must not be conducted by individuals who are or were part of the development team. The summative usability evaluation is to be designed as a validation study.
For this purpose, representative Chinese users shall be recruited in accordance with the intended user profiles. Similar to the FDA, the NMPA recommends conducting the usability test with 15 participants per relevant user group. With regard to the conduct of the usability test, realistic simulation of the use environment shall be ensured in the sense of a simulated use test. In this context, labels, instructions for use, and any required product training shall also be considered in the intended market configuration.
Attention should also be paid to any potentially required training decay. In line with other standards and guidelines, use errors, close calls, and use difficulties shall be recorded and analyzed with regard to their root causes. In cooperation with risk management, this serves to generate a sufficient data basis to demonstrate the effectiveness of the risk control measures and to support the acceptability of the residual risk. If the data are sufficient, the usability engineering research report shall be compiled.

4How are the Use Error Evaluation Report and the Usability Engineering Research Report structured?

Depending on the specific case, either the use error evaluation report or the usability engineering research report provides the complete line of argumentation and body of evidence demonstrating the safe and effective use of the medical device for the NMPA. The following table presents the recommendations contained in the Guideline regarding the structure of the two documents:

Use Error Evaluation Report

  1. Basic information
  2. Level of risk of use
  3. Core elements

4a. Analysis of post-market use problems of similar medical devices

5a. Use-risk management

6a. Conclusion

Usability Engineering Research Report

  1. Basic information
  2. Level of risk of use
  3. Core elements

4b. Usability engineering process

5b. User interface requirements specification

6b. Use-risk management

7b. Verification and validation of the user interface

8b. User interface traceability analysis

9b. User training scheme

10b. Conclusion

In the following, the individual chapters of the two documents are explained in greater detail (use error evaluation report (a), usability engineering research report (b)).

Chapter 1: Basic information

Both documents begin with the basic information. The content is comparable to that of the use specification and primarily relates to general product descriptions. However, user profiles and the description of the use environment are to be provided in Chapter 3, “Core elements”.

Chapter 2: Level of risk of use

In the chapter level of risk of use, the derivation of the use‑risk level for the product under consideration shall be presented clearly and comprehensibly. Compared to IEC 62366‑1 and the FDA Guidance, this chapter is new and goes beyond the typical documentation contained in the usability engineering file. While a risk‑based approach is also applied in IEC 62366‑1:2015, for example with regard to the selection of hazard‑related use scenarios or the definition of critical tasks in accordance with FDA Guidance, a more detailed justification of the risk assessment is required here.

Chapter 3: Core elements

In the chapter core elements, the NMPA requires the creation of use scenarios understood as a sequence of human–machine interactions. In addition to the requirements of the IEC standard, these should also include textual and/or pictorial references to the user interface. The use scenarios should furthermore contain detailed descriptions of the use settings and environmental conditions. A key extension compared to IEC 62366‑1 is the classification of the considered user tasks along three central dimensions: Criticality, operation urgency, and operation frequency. This detailed categorization supports the systematic identification of potential risks within the framework of an NMPA‑compliant task analysis.
User-task-clasification

Practical examples for the general illustration of the classification of different user tasks

1
Infusion pump
Setting the flow rate
User task classification:
  • critical,
  • non-urgent,
  • non-frequent 

Rationale:

Criticality – Setting the flow rate determines the amount of medication or fluid administered. An incorrectly set value may result in over‑infusion or under‑infusion and can immediately cause critical physiological conditions (e.g., hypotension, hyperkalemia, shock, respiratory depression – depending on the active substance). The task is therefore critical.
Operation urgency – The setting is typically not performed under time pressure. It is carried out prior to the start of therapy or during planned adjustments. Although the potential harm is high, there is usually no second‑ or minute‑level time pressure during input. The task is therefore non‑urgent.
Operation frequency – Setting or adjusting the flow rate is not required on a continuous basis. It is an episodic action performed at the start of the infusion or during individual therapy adjustments. The task is therefore non‑frequent.
2

Ventilator

Immediate increase of oxygen concentration

User task classification:
  • critical,
  • urgent,
  • non-frequent 

Rationale:

Criticality – The oxygen concentration has an immediate effect on the patient’s oxygenation. An insufficient increase of the O₂ fraction can rapidly lead to hypoxia, which may cause acute organ damage or circulatory failure. The task is therefore critical.
Operation urgency – The need to increase oxygen delivery often arises suddenly, for example in the event of oxygen saturation decline, respiratory insufficiency, or unexpected clinical deterioration. In such situations, a response is required within seconds. The task is therefore urgent.
Operation frequency – An immediate increase in oxygen delivery is not performed routinely. It occurs only in the presence of clinical complications or unstable patient conditions. The task is therefore non‑frequent.
3

Patient monitor

Confirmation of an alarm

User task classification:
  • non-critical,
  • non-urgent,
  • frequent 

Rationale:

Criticality – Confirmation of an alarm does not directly affect the patient’s physiological parameters. It serves system interaction rather than direct therapy adjustment. Potential harm arises only indirectly, for example through alarm fatigue or missed critical alarms. The task is therefore non‑critical.

Operation urgency – Confirmation of an alarm is not time‑critical, as the clinically relevant action (e.g., intervention in a critical condition) must be performed independently of alarm confirmation. The confirmation primarily serves alarm management rather than immediate patient stabilization. The task is therefore non‑urgent.
Operation frequency – Confirmation of alarms occurs very frequently in clinical environments, particularly in intensive care units. The high alarm rate results in regular interaction with the alarm interface. The task is therefore frequent.

Chapter 4a : Analysis of post-market use problems of similar medical devices

This analysis report may be prepared as part of a clinical literature search and typically includes information on the search object (the medical device), the search content (how the search was conducted and which sources were reviewed), as well as the search results (including the preparation of a document list and the submission of full texts). As a general rule, the search should cover the past five years. It should be noted that the scope of the literature search should include both the major global databases for medical device adverse events and recalls, as well as Chinese and international literature databases.

Chapter 4b : Usability engineering process

In this chapter, the NMPA requires the illustration of the project‑specific usability engineering process by means of a flowchart. A table of contents for the usability engineering file shall also be provided, along with a brief description of the content and requirements of each activity performed within the process.

Chapter 5a & 6b: Use-risk management 

The NMPA Guideline requires the submission of risk management documentation for the medical device to be registered, including the clear identification of the use‑related risks contained therein. Alternatively, a separate use‑related risk management file may be submitted. The use‑related risk management should include an analysis of use errors of similar medical devices that are already known based on post‑market surveillance data. In addition, it should cover a comprehensive risk analysis of all known use errors of the submitted medical device as well as the corresponding risk control measures, in order to demonstrate that the remaining use‑related residual risk is acceptable.

Chapter 5b: User interface requirements specification

This section requires the presentation of the user interface requirements specifications of the medical device, which is comparable to Chapter 5.6 of IEC 62366‑1:2015/AMD1:2020. If no separate user interface requirements specification file is available, the product requirement specification file may be submitted, provided that the user interface specification contained therein is clearly identified.

Chapter 7b: Verification and validation of the user interface

Here, the NMPA requires a description of the content and requirements of the evaluation activities related to the verification and validation of the user interface of the medical device. The term “verification” is largely equated with formative evaluation, while “validation” is equated with summative evaluation. In comparison with other standards and guidelines, it should be emphasized that the NMPA Guideline requires the submission of a user interface verification, which essentially corresponds to the formative user interface evaluation of the medical device. If a comparative evaluation with an equivalent medical device is conducted, this replaces the plan and report of the summative usability test.

Chapter 8b: User interface traceability analysis

At this point, the creation and submission of a user interface traceability analysis report is required, which transparently and comprehensibly demonstrates the relationships between the user interface requirements, the design, verification (formative evaluations), validation (summative evaluation), and risk management.

Chapter 8b, “User interface traceability analysis”, represents a novel requirement compared to other commonly used usability standards and guidelines. We recommend the development of a matrix structure that presents and cross‑references all previously described activities. This should be complemented by detailed descriptions of the relationships between the individual activities, explaining how the activities interact and interrelate.

Chapter 9b: User training scheme

If applicable, a training scheme for the medical device to be registered shall be developed at this point, describing the user training scheme, the materials, methods, and trainers used, and providing evidence of the evaluation of training effectiveness.

Chapter 6a & 10b: Conclusion 

Here, the overall usability engineering process shall be briefly described in conclusion, essentially in the form of a management summary. In particular, it shall be demonstrated to what extent the use‑related residual risks have been reduced to an acceptable level, and that the safety and effectiveness of the user interface are ensured.

5When are usability tests required to be conducted in China?

Whether summative usability tests with the medical device are required is determined by the decision logic described in Chapter 3, “Scope of usability activities and documentation,” with the use‑risk level and the available data basis regarding equivalent medical devices being decisive. For products with high use‑risk and without robust evidence of an equivalent medical device, the NMPA generally expects a summative usability evaluation in the form of simulated use tests with Chinese users in a sufficiently simulated Chinese use context / simulation environment. The Guideline requires at least 15 Chinese participants per relevant user group in order to reliably identify use errors.

The Guideline provides for careful selection of participants, training where applicable, and data collection with a focus on the critical tasks. The Guideline emphasizes that individuals who frequently participate in usability tests of the same device or other devices from the same manufacturer should be excluded. Notably, compared to other guidelines, the NMPA Guideline explicitly expects a justification if no device training is required for test participants. The test reports should contain detailed information on the objectives, simulation conditions, results with respect to use errors and the associated root causes, as well as any deviations.

Once it has been determined that usability tests are required to be conducted in China, the question of practical implementation arises. While the NMPA does not specify a concrete qualification profile, it formulates clear requirements regarding the qualification and independence of the individuals conducting the tests – the evaluation shall be planned, conducted, and analyzed by individuals with demonstrable experience in usability testing of medical devices. Members of the manufacturing company who are heavily involved in the development of the device should not be assigned to conduct the evaluation.

For international manufacturers, two implementation models have essentially become established in practice:
  • China‑specialized usability testing laboratories Conducting the study through partners with experienced usability testing personnel and their own infrastructure (laboratories, recruitment panels), with close substantive coordination with the manufacturer’s central usability team.
  • Manufacturer‑internal implementation via local subsidiaries
    Conducting the study at a Chinese subsidiary or in a company‑owned usability laboratory, provided that the moderating personnel are independent of the development team and have sufficient experience in usability testing; often in combination with external consulting to ensure NMPA‑compliant documentation.
For the Chinese authority, it is less decisive whether the study is conducted in a manufacturer’s laboratory, at an external test laboratory, or in a hospital, but rather whether the design, conduct, and documentation of the evaluation transparently demonstrate that all critical tasks can be performed safely under Chinese conditions. Clear documentation of the roles (who plans, moderates, and analyzes), the qualifications of the involved parties, and the interfaces to risk management is therefore an essential component of the documentation to be submitted.

6Conclusion – How to successfully prepare usability documentation for registration on the Chinese market

The “Guideline for Registration Review of Usability Engineering of Medical Devices” issued by the NMPA is the central reference for the assessment of usability within the Chinese registration procedure. For manufacturers with an established usability engineering process in accordance with IEC 62366‑1:2015, this means that the fundamental workflow—use specification, hazard-related use scenarios, formative and summative evaluations—remains familiar. However, the NMPA shifts the focus from a primarily internal usability engineering file toward reviewable documents that must stand on their own within the registration dossier (use error evaluation report or usability engineering research report). The recommended structure of these documents presented in Chapter 4 precisely reflects this dossier‑oriented approach.

For successful registration in China, it is therefore not sufficient to simply “submit” an existing IEC 62366‑1 process. What is decisive is that manufacturers consistently translate their usability evidence into the NMPA framework: with a clearly defined use‑risk level, a transparent decision logic (use error evaluation report vs. usability engineering research report), China‑specific summative usability tests where applicable, and reviewable documentation within the registration dossier. Manufacturers that proceed in such a systematic manner not only increase their chances of a timely market approval.

They also ensure that their products are used safely and effectively by the appropriate user groups in everyday clinical practice in China, in accordance with the labeling – thereby positioning themselves sustainably in one of the world’s most important MedTech markets.

Disclaimer

The information on standards and guidelines presented in this technical article has been prepared to the best of the author’s knowledge and expertise. It reflects solely the opinion of the author. No guarantee can be given with regard to the completeness, timeliness, or accuracy of the information provided. Standards and guidelines are subject to regular revisions and amendments, which may not always be immediately reflected here. This article does not constitute binding advice and does not replace a review of the applicable standards and guidelines by qualified experts or official bodies. For the application and interpretation of standards and guidelines, the currently valid original documents and the responsible organizations are authoritative.

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