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Developing a Strategic Regulatory Framework for Compliance of AI-Enabled Medical Devices under EU MDR 2017/745 and EU AI Act 2024/1689
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1.
1. I consent to being a participant in this research study.
(Required.)
Yes
No
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2.
What is your current role in the Medical Device industry?
(Required.)
Regulatory Affairs Professional
PRRC (Person Responsible for Regulatory Compliance)
QA Professional
AI / Software Developer
Research and Development
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3.
What is your current duration of experience within the Medtech industry
(Required.)
Less than 1 year
1 to 5 years
Greater than 5 years
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4.
What is the current demographic of your organization?
(Required.)
Within the EU
Outside the EU
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5.
What is the size of your organization?
(Required.)
Less than 10 employees
10 to 100 employees
100 to 500 employees
Greater than 500 employees
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6.
How familiar are you with EU MDR 2017/745?
(Required.)
Extremely familiar
Very familiar
Somewhat familiar
Not so familiar
Not at all familiar
Other (please specify)
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7.
How familiar are you with EU AI Act 2024/1689
(Required.)
Extremely familiar
Very familiar
Somewhat familiar
Not so familiar
Not at all familiar
Other (please specify)
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8.
Within your organization, with regards to AI, which of the following statements apply?
(Required.)
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)
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9.
Within your organization’s current product offering, which of the following statements apply?
(Required.)
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)
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10.
What risk classification applies to AI enabled medical devices in your organization under EU MDR?
(Required.)
Class 1 – Low Risk
Class 2a – Medium Risk
Class 2b – Medium to high Risk
Class 3 – High Risk
Not Sure
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11.
What risk classification applies to AI enabled medical devices in your organization under EU AI Act 1689?
(Required.)
Unacceptable Risk
High Risk
Limited Risk
Minimal Risk
Not Sure
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12.
Please indicate the extent to which you agree that the following are significant compliance challenges for AI-enabled medical devices:
(Required.)
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
AI explainability and transparency
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
Dual compliance with both EU MDR 2017/745 and EU AI Act 2024/1689
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
Bias and data quality issues
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
Post-market surveillance requirements for AI systems
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
Risk classification under MDR/AI Act
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
Please briefly explain your answer.
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13.
To what extent do you agree with the following statement:
(Required.)
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."
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
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.):
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15.
Has your organization integrated the requirements of AI enabled medical devices into its QMS?
(Required.)
Yes
No
Currently in process of integrating
Unsure
Other (please specify)
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."
Strongly Disagree
Disagree
Neutral
Agree
Strongly Agree
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):
Current Progress,
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