Annex D
We took the stricter reading of all three
MDR, the AI Act and GDPR are treated at their most demanding interpretation. Nothing is submitted while a submission-gate item is open.
Compliance checklist
D02 · EU MDR
PENDINGMDR Rule 11 classification confirmed with notified body
Owner: AeroGlyphics
D03 · EU MDR
AGREEDClass IIa+ technical file structure adopted from day one
Owner: AeroGlyphics
D05 · EU MDR
AGREEDClinical evaluation plan referencing paired CPET validation
Owner: SOAP Health
D06 · AI Act
CONFIRMEDSystem treated as high-risk; no wellness exemption claimed
Owner: AeroGlyphics
D08 · AI Act
AGREEDModel cards and data-governance records for every released model
Owner: GoApercu
D10 · AI Act
AGREEDHuman oversight design documented on the clinician surface
Owner: SOAP Health
D12 · GDPR
PENDINGLawful basis established with each imaging site
Owner: Medome
D14 · GDPR
PENDINGEU–US transfer mechanism for model training data
Owner: GoApercu
D16 · GDPR
AGREEDDPIA completed and reviewed before prospective recruitment
Owner: Medome
| ID | Regime | Statement | Owner | Status |
|---|---|---|---|---|
| D02 | EU MDR | MDR Rule 11 classification confirmed with notified body | AeroGlyphics | PENDING |
| D03 | EU MDR | Class IIa+ technical file structure adopted from day one | AeroGlyphics | AGREED |
| D05 | EU MDR | Clinical evaluation plan referencing paired CPET validation | SOAP Health | AGREED |
| D06 | AI Act | System treated as high-risk; no wellness exemption claimed | AeroGlyphics | CONFIRMED |
| D08 | AI Act | Model cards and data-governance records for every released model | GoApercu | AGREED |
| D10 | AI Act | Human oversight design documented on the clinician surface | SOAP Health | AGREED |
| D12 | GDPR | Lawful basis established with each imaging site | Medome | PENDING |
| D14 | GDPR | EU–US transfer mechanism for model training data | GoApercu | PENDING |
| D16 | GDPR | DPIA completed and reviewed before prospective recruitment | Medome | AGREED |
Submission gate — open questions
- MDR Rule 11 class (D02) — determines the entire conformity route and the WP6 timeline.
- Imaging-site lawful basis (D12) — blocks the retrospective n=800 derivation cohort.
- EU–US transfer mechanism (D14) — blocks SleepFM adaptation on EEA-origin data.