SHAIPED Survey Form

SHAIPED questionnaire to Notified Body

SHAIPED Stakeholder Survey

About this questionnaire

This questionnaire is part of the SHAIPED project, a European initiative exploring how EHDS-enabled health data access can support the development, assessment, and deployment of Medical Device Artificial Intelligence (MDAI) in Europe.

Within SHAIPED, this work focuses specifically on the role of Real-World Data (RWD) in MDAI post-testing stages — market certification, post-market surveillance, clinical follow-up, HTA and reimbursement processes.

We are exploring how accessing high-quality RWD through services of the future Health Data Access Bodies (HDABs) may help address the challenges faced by MDAI stakeholders.

We welcome contributions both from experts with direct experience evaluating MDAI and from experts who may not yet have assessed these technologies but can provide valuable insights into how such processes should be shaped in the future.

The questionnaire contains 7 sections. Completing the questionnaire should take approximately 20 minutes.

The results will be made available in project deliverables published on the SHAIPED webpage, and we will also send the respective documents to the email address used to contact you.

You can find additional details on SHAIPED and our survey from the Participant Information Sheet.

For any questions, please contact: info@shaiped.eu

Thank you very much for your time and for sharing your expertise.

Section 0 — Organisation Profile

Contact name (optional)

Role / position (optional)

Your role and affiliation, if you would like to share it.

Organisation name

Please update your organization name, if necessary.

Contact email (optional — for confirmation)

Country

If your organization operates at country level, please select one. Otherwise, leave empty.

Governance level

Select the level at which your organization primarily acts.

Is your organisation mandated under Regulation (EU) 2017/745 on medical devices (MDR)?

Yes

Does your organisation assess Medical Devices with Artificial Intelligence (MDAI) under MDR/IVDR?

Yes

Is MDAI formally differentiated from other software medical devices?

Yes

How is this distinction operationalised?

Over the past 24 months, how has your organisation been involved in MDAI activities?

Additional notes on your organisation

Section 2 — Barriers to acceptance of RWD/RWE

Which evidence gaps most frequently prevent or delay a positive conformity-assessment outcome for MDAI? Rank the most important (1 = most important). Ranking is optional.

Evidence gap	Rank
Insufficient clinical evidence
Insufficient external validation
Inadequate representativeness of study populations
Insufficient statistical power / sample size
Poor data quality / completeness
Lack of standardisation / interoperability / linkage
Insufficient transparency or explainability
Inadequate cybersecurity evidence
Insufficient PMS / PMCF planning
Inadequate change-management strategy
Insufficient bias assessment
Insufficient human-oversight documentation

Which differences have you observed in how different Notified Bodies approach RWD requirements for MDAI assessments? (please describe)

How would you characterise the extent of these differences?

In your view, what might contribute to these differences?

Would additional EU-level guidance be of value in this regard, in your view?

What developments, if any, would you consider most helpful for consistency in practice? (please describe)

Section 3 — Adaptive AI & lifecycle evidence needs

How does your organisation differentiate between static and adaptive AI systems during conformity assessment?

How prepared is the current MDR/IVDR framework for continuously learning or adaptive AI?

Which evidence should be required following a significant model update?

Technical validation
Clinical validation
External validation
RWD-based monitoring
Bias assessment
Human factors testing
Cybersecurity review

In your view, would a pre-approved change specification framework (a concept applied in some other jurisdictions, such as FDA Predetermined Change Control Plans) be of value for MDAI assessment in Europe? Please explain.

Section 5 — Regulatory framework

Which aspects of the current regulatory framework create the greatest practical challenges during conformity assessment of MDAI?

In your opinion, how would applying separate MDR and AI Act requirements versus an integrated framework (AI requirements included within the MDR/IVDR) affect each of the following?

Administrative burden
Legal clarity
Consistency of conformity assessment
Efficiency of assessment
Innovation and market access

Section 6 — Closing

In your view, what is the most significant challenge to effective use of RWD/RWE in MDAI conformity assessment — and what would most help address it?

What differences have you observed between the EU and other jurisdictions (e.g. the US, UK and Asia) in the conformity assessment of MDAI and the use of real-world data (RWD) and real-world evidence (RWE)?

Please describe any differences you have observed — for example in evidence requirements, acceptance of RWD/RWE, assessment of adaptive AI, regulatory guidance, or post-market evidence expectations.

Do you have any recommendations regarding MDAI certification in Europe?

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Clinical evaluation
Performance evaluation
External validation
Generalisability assessment
PMCF
PMS
Bias assessment
Safety monitoring