Screen Reader Mode Icon Check SCREEN READER MODE to make this survey compatible with screen readers. Developing a Strategic Regulatory Framework for Compliance of AI-Enabled Medical Devices under EU MDR 2017/745 and EU AI Act 2024/1689 Question Title * 1. 1. I consent to being a participant in this research study. Yes No OK Question Title * 2. What is your current role in the Medical Device industry? Regulatory Affairs Professional PRRC (Person Responsible for Regulatory Compliance) QA Professional AI / Software Developer Research and Development OK Question Title * 3. What is your current duration of experience within the Medtech industry Less than 1 year 1 to 5 years Greater than 5 years OK Question Title * 4. What is the current demographic of your organization? Within the EU Outside the EU OK Question Title * 5. What is the size of your organization? Less than 10 employees 10 to 100 employees 100 to 500 employees Greater than 500 employees OK Question Title * 6. How familiar are you with EU MDR 2017/745? Extremely familiar Very familiar Somewhat familiar Not so familiar Not at all familiar Other (please specify) OK Question Title * 7. How familiar are you with EU AI Act 2024/1689 Extremely familiar Very familiar Somewhat familiar Not so familiar Not at all familiar Other (please specify) OK Question Title * 8. Within your organization, with regards to AI, which of the following statements apply? AI forms part of my organizations strategic goals We use AI informally without formal strategy Our organization discourages AI use We do not use AI in any manner that I am aware of Other (please specify) OK Question Title * 9. Within your organization’s current product offering, which of the following statements apply? We currently offer AI enabled medical devices to the EU market We currently offer, and are also developing additional AI enabled medical devices for the EU market We are currently in the development phase of AI enabled medical devices for the EU market We do not currently have AI enabled medical devices available on the EU market, and have no plans for developing AI enabled medical devices that I am aware of Other (please specify) OK Question Title * 10. What risk classification applies to AI enabled medical devices in your organization under EU MDR? Class 1 – Low Risk Class 2a – Medium Risk Class 2b – Medium to high Risk Class 3 – High Risk Not Sure OK Question Title * 11. What risk classification applies to AI enabled medical devices in your organization under EU AI Act 1689? Unacceptable Risk High Risk Limited Risk Minimal Risk Not Sure OK Question Title * 12. Please indicate the extent to which you agree that the following are significant compliance challenges for AI-enabled medical devices: Strongly Disagree Disagree Neutral Agree Strongly Agree AI explainability and transparency AI explainability and transparency Strongly Disagree AI explainability and transparency Disagree AI explainability and transparency Neutral AI explainability and transparency Agree AI explainability and transparency Strongly Agree Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689 Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689 Strongly Disagree Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689 Disagree Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689 Neutral Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689 Agree Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689 Strongly Agree Bias and data quality issues Bias and data quality issues Strongly Disagree Bias and data quality issues Disagree Bias and data quality issues Neutral Bias and data quality issues Agree Bias and data quality issues Strongly Agree Post-market surveillance requirements for AI systems Post-market surveillance requirements for AI systems Strongly Disagree Post-market surveillance requirements for AI systems Disagree Post-market surveillance requirements for AI systems Neutral Post-market surveillance requirements for AI systems Agree Post-market surveillance requirements for AI systems Strongly Agree Risk classification under MDR/AI Act Risk classification under MDR/AI Act Strongly Disagree Risk classification under MDR/AI Act Disagree Risk classification under MDR/AI Act Neutral Risk classification under MDR/AI Act Agree Risk classification under MDR/AI Act Strongly Agree Please briefly explain your answer. OK Question Title * 13. To what extent do you agree with the following statement: Strongly Disagree Disagree Neutral Agree Strongly Agree "The current regulatory requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 provide sufficient clarity and support for implementing robust data governance practices in AI-enabled medical devices." "The current regulatory requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 provide sufficient clarity and support for implementing robust data governance practices in AI-enabled medical devices." Strongly Disagree "The current regulatory requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 provide sufficient clarity and support for implementing robust data governance practices in AI-enabled medical devices." Disagree "The current regulatory requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 provide sufficient clarity and support for implementing robust data governance practices in AI-enabled medical devices." Neutral "The current regulatory requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 provide sufficient clarity and support for implementing robust data governance practices in AI-enabled medical devices." Agree "The current regulatory requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 provide sufficient clarity and support for implementing robust data governance practices in AI-enabled medical devices." Strongly Agree OK Question Title * 14. Please briefly explain what, if any, aspects of data governance you find under-supported (e.g., dataset bias, black box, traceability, data quality requirements, etc.): OK Question Title * 15. Has your organization integrated the requirements of AI enabled medical devices into its QMS? Yes No Currently in process of integrating Unsure Other (please specify) OK Question Title * 16. To what extent do you agree with the following statement: Strongly Disagree Disagree Neutral Agree Strongly Agree "The post-market surveillance (PMS) requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 are sufficiently aligned and effective for monitoring the ongoing performance and safety of AI-enabled medical devices." "The post-market surveillance (PMS) requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 are sufficiently aligned and effective for monitoring the ongoing performance and safety of AI-enabled medical devices." Strongly Disagree "The post-market surveillance (PMS) requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 are sufficiently aligned and effective for monitoring the ongoing performance and safety of AI-enabled medical devices." Disagree "The post-market surveillance (PMS) requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 are sufficiently aligned and effective for monitoring the ongoing performance and safety of AI-enabled medical devices." Neutral "The post-market surveillance (PMS) requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 are sufficiently aligned and effective for monitoring the ongoing performance and safety of AI-enabled medical devices." Agree "The post-market surveillance (PMS) requirements under the EU MDR 2017/745 and the EU AI Act 2024/1689 are sufficiently aligned and effective for monitoring the ongoing performance and safety of AI-enabled medical devices." Strongly Agree OK Question Title * 17. Please briefly explain what gaps or challenges you believe exist in the current PMS requirements (e.g., handling adaptive algorithms, data feedback loops, transparency reporting, real-time monitoring expectations): OK NEXT