QMS & Global Regulatory ServicesUsability engineering is an essential aspect of medical device safety, focusing on the interaction between the device, its intended users, and the use environment. An effective usability engineering process helps manufacturers identify foreseeable use errors, evaluate their potential impact on patient and user safety, and implement appropriate measures to reduce associated risks.
What Must Manufacturers Consider?
Manufacturers should establish a usability engineering process appropriate to the device's intended purpose, user interface, and associated risks.
Key activities include:
- Intended users and use environment: Identify the individuals expected to operate or handle the device and the environments in which it will be used.
- User interface assessment: Evaluate relevant device features, controls, connections, labelling, and instructions for use that could influence safe operation.
- Use-related risk analysis: Identify foreseeable use errors, hazardous situations, and potential harm arising from user interaction.
- Risk control measures: Implement appropriate design measures, protective measures, and information for safety to reduce identified risks.
- Usability evaluation: Assess whether the user interface supports safe use and whether implemented risk controls adequately address relevant use-related risks.
What Documentation Is Required?
Manufacturers should maintain documented evidence demonstrating that usability-related risks have been systematically evaluated and addressed. The Usability Engineering File (Including Plan and Report) contains or references the records generated throughout the usability engineering process.
Depending on the device and its associated risks, the documentation may include:
- Usability engineering plan and use specification.
- User interface specifications.
- Use-related risk analysis and identified hazardous use scenarios.
- Documented risk control measures and their evaluation.
- Usability evaluation protocols and reports, where applicable.
- Usability engineering report and supporting records.
These records may be incorporated into the manufacturer's existing design and development documentation and risk management file, provided that the usability engineering activities and their outcomes remain adequately documented and traceable.
How Does Usability Engineering Support EU MDR Compliance?
Usability engineering supports the demonstration of conformity with the applicable General Safety and Performance Requirements (GSPRs) under Annex I of the EU MDR. Its findings should be consistent with the device's risk management documentation, design specifications, labelling, and instructions for use.
Usability-related information obtained through complaint handling, post-market surveillance, and other post-market activities should also be reviewed to determine whether additional risk controls, design modifications, or updates to user information are necessary.
How Does Usability Engineering Supports USFDA Compliance?
As per FDA Guidance on: Content of Human Factors Information in Medical Device Marketing Submissions, Medreg assist for what human factors information should be included in marketing submissions. It includes determination of HF submission category. Under Appendix of these FDA Guidance, it requires device’s risk management documentation, user interactions, trainings, HFE/UE analyses and evaluations, labelling and post-market use error problems.
