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

Follow-up to PR #34 (merged). Addresses one codex P2 finding.

## Fix — Regulatory basis for Rule 11 / Class IIa (codex P2)

The §4 standards / vocabularies index cited "IVD-MDR Rule 11" as the
EU SaMD risk classification for splat-native ultrasound. This is the
wrong regulation. IVDR (the In-Vitro Diagnostic Regulation 2017/746)
governs IN-VITRO DIAGNOSTICS (e.g., blood tests, immunoassays) and
uses A-D risk classes. Ultrasound SaMD is regulated under the MDR
(Medical Device Regulation 2017/745); the applicable classification
rule is **MDR Annex VIII Rule 11**.

Because this section is the regulatory cross-reference future
D-SPLAT-14 (SaMD documentation track) work will follow, leaving the
wrong regulation name would send the certification/evidence plan
down the wrong rule set for the stated ultrasound device.

Fix: corrects the IVD-MDR entry to MDR Annex VIII Rule 11 and adds
a half-sentence call-out explaining that IVDR is a separate
framework that does NOT govern this device. The Class IIa
classification claim is unchanged (just attached to the correct
regulation now).

Companion fix in the lance-graph canonical plan (PR follow-up to
#471) which had the same wrong citation in the D-SPLAT-14 row of
both the plan body and the STATUS_BOARD.

## What's NOT in this PR

- Source code: still none. Narrative-only doc.
- The other regulatory standards (IEC 62366 usability, IEC 80001
  risk, ISO 14971 risk-management) are unchanged.
- The Class IIa classification claim itself is unchanged (it was
  correct; only the regulation citation was wrong).

## Test plan

- [x] Codex P2 (regulatory basis) — IVD-MDR → MDR Annex VIII Rule 11.
- [x] Cross-grep: no remaining IVD-?MDR references in this file.
- [ ] Codex re-review on this PR.

Author: AdaWorldAPI

docs/SPLAT-NATIVE-CUSTOMER.md

@@ -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.
 
 ---