SHAIPED Survey Form

EC Group & Committee

SHAIPED Stakeholder Survey

Section 0 — Organisation Profile

Organisation name

Contact email (optional — for confirmation)

Country

Governance level

Mandate scope (select all that apply)

MDR

IVDR

AI Act

EHDS

HTA Regulation

GDPR

Other

How does your group contribute to the governance of MDAI within the EU?

To what extent has the use of Real-World Data (RWD) in MDAI been addressed within your group's work?

Do Real-World Data play a role in MDAI certification? If yes, what role?

Does the European Commission offer Secure Processing Environments (SPEs)?

Yes

How does the EC ensure autonomy, sovereignty, and full control over European health data?

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 2 — Adaptive vs. Static AI

Is the evolving/adaptive nature of MDAI adequately addressed in current EU-level governance frameworks?

Yes

Which structural elements are most urgently needed at EU level for coherent governance of adaptive MDAI?

Section 3 — RWD Acceptance & Quality

Is there sufficient clarity at EU level regarding acceptable RWD for MDAI evaluation?

Which aspects of RWD use in MDAI would most benefit from further EU-level standardisation?

How do anonymisation/pseudonymisation requirements influence lifecycle evaluation of MDAI using RWD? (cross-border, federated, balance)

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?

Framework	Alignment	Notes
MDR
IVDR
AI Act
EHDS
HTA Regulation
GDPR
Other

What are the main drivers of variability in MDAI governance across Member States?

Do you perceive duplication or misalignment between CE-marking and HTA/reimbursement RWD requirements?

Yes

Where does duplication occur?

Are current regulatory structures sufficient to address the adaptive nature of MDAI?

Yes

Which structural elements require clarification?

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EC Group &amp; Committee

EC Group & Committee