SHAIPED Survey Form

SHAIPED Stakeholder Survey

Section 1 — Real-world data across the MDAI Lifecycle

For each lifecycle phase, indicate how Real-World Data are used within your activities.

Phase	Level of use	Main purpose	Type of RWD	Formalised?
Pre-market			Electronic Health Records Patient Registry Claims / Administrative Wearable / Sensor Genomic Imaging PMS / Adverse Events Other
Post-market Monitoring			Electronic Health Records Patient Registry Claims / Administrative Wearable / Sensor Genomic Imaging PMS / Adverse Events Other
HTA / Reimbursement			Electronic Health Records Patient Registry Claims / Administrative Wearable / Sensor Genomic Imaging PMS / Adverse Events Other

If RWD use is limited or inconsistent, describe the main barriers.

Section 4-add — Reimbursement & Uncertainty

Does your organisation use conditional reimbursement, MEAs, or Coverage with Evidence Development for MDAI?

Yes

How are RWD integrated into such schemes?

What is the typical duration of evidence collection periods?

What triggers reassessment of reimbursement?

Do you perceive misalignment between CE-marking and HTA/reimbursement evidence expectations?

Yes

Where is this misalignment most evident?

Section 5 — Harmonisation (Optional)

This section is optional. Answer if time allows.

To what extent are EU regulatory instruments aligned regarding RWD use in MDAI?

How consistent are RWD-related practices across Member States?

Are current assessment and reimbursement structures sufficient to support lifecycle governance of adaptive MDAI?

Yes

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