Enhancing usability in medical devices: A key to MDR compliance and patient safety

In the ever-evolving field of medical technology, usability engineering has become a critical factor in ensuring patient safety and regulatory compliance. Medical devices are used by a wide range of users, from trained healthcare professionals to patients at home. If the device interface is not intuitive or prone to user errors, serious risks can arise, affecting both the efficiency of medical workflows and patient outcomes.

This is why MDR (Medical Device Regulation) places a strong emphasis on usability engineering. Compliance with IEC 62366-1 and IEC TR 62366-2 is not just a regulatory requirement but also a best practice for designing medical devices that are safe, effective, and user-friendly.

So, what should manufacturers consider when conducting usability studies for MDR certification? Let's explore the key principles of usability engineering and how they contribute to risk management and regulatory approval.

Key principles usability engineering

For the certification of a device under MDR (Medical Device Regulation), usability studies must be conducted in accordance with the IEC 62366-1 and IEC TR 62366-2 standards. Here are the key aspects to consider based on these standards:

1. Start the usability engineering process early

• Usability engineering studies should be initiated early in the device development process. If started too late, the device may fail to meet user needs and increase risks​.

2. User Interface (UI) design and specification

• The User Interface Specification should define the technical requirements related to the device’s user interface.
• It should include aspects such as screen visibility, alarm sound levels, and touch screen sensitivity​.

3. User profiles, use scenarios, and task analysis

• The intended users, the tasks they will perform, and the environments in which the device will be used must be identified.
• Expected user tasks should be analyzed to determine potential use errors and the risks they may cause​.

4. Integration with risk management

• User interface errors should be evaluated like other mechanical or software failures.
• The identification of user errors must be integrated into the risk management process, and risk mitigation measures should be implemented​.

5. Usability testing (Formative & Summative Evaluation)

• Formative evaluation: Interim assessments conducted during UI design to detect and correct errors early.
• Summative evaluation: Final evaluation to demonstrate that the UI design ensures user safety and device usability​.

6. Identification of hazards and hazard-related use scenarios

• Possible hazardous situations that users might encounter must be identified, and risk mitigation strategies must be developed.
• For instance, if a display is difficult to read, it may lead to errors in patient treatment, so display readability should be improved​.

7. User Interface evaluation plan

• A UI evaluation plan should outline how usability tests will be conducted and what methodologies will be used.
• Tests conducted with real users are crucial to determine if the device is user-friendly and whether it effectively reduces error risks​.

8. Usability engineering file

• All usability engineering processes, test results, and corrective actions must be documented.
• This usability engineering file serves as evidence required during the device certification process​.

Conducting usability studies in compliance with these standards facilitates the MDR certification process while enhancing patient safety by minimizing user errors.