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docs(splat-native): address review feedback on #34 (IVD-MDR → MDR Annex VIII Rule 11) #35

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AdaWorldAPI merged 1 commit into from
Jun 5, 2026
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docs(splat-native): address review feedback on #34 (IVD-MDR → MDR Annex VIII Rule 11) #35

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12 changes: 10 additions & 2 deletions docs/SPLAT-NATIVE-CUSTOMER.md
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Expand Up @@ -242,8 +242,16 @@ arc.
(per HEALTHCARE-TRANSCODING.md §1).
- **IEC 62366 (usability) + IEC 80001 (risk) + ISO 14971 (risk mgmt)** —
SaMD certification standards referenced by D-SPLAT-14.
- **IVD-MDR Rule 11** — EU SaMD risk classification (Class IIa for
diagnostic-software with non-critical decision support).
- **MDR Annex VIII Rule 11** — EU SaMD risk classification. Software
intended to provide information used to make decisions for
diagnostic or therapeutic purposes is Class IIa (or higher); the
splat-native ultrasound SaMD path lands here per the canonical
plan's §3.14 (D-SPLAT-14). **Note:** IVDR (the in-vitro diagnostic
regulation 2017/746) is a separate framework for in-vitro
diagnostics and uses A–D risk classes; it does NOT govern this
device. The MDR (regulation 2017/745) is the correct framework
for ultrasound SaMD; Annex VIII Rule 11 is the classification
rule that applies.

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