From 86a5173751faba230fd9ffb8bc13a74aaa658512 Mon Sep 17 00:00:00 2001 From: AdaWorldAPI Date: Fri, 5 Jun 2026 12:22:09 +0200 Subject: [PATCH] =?UTF-8?q?docs(splat-native):=20address=20review=20feedba?= =?UTF-8?q?ck=20on=20#34=20(IVD-MDR=20=E2=86=92=20MDR=20Annex=20VIII=20Rul?= =?UTF-8?q?e=2011)?= MIME-Version: 1.0 Content-Type: text/plain; charset=UTF-8 Content-Transfer-Encoding: 8bit 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. --- docs/SPLAT-NATIVE-CUSTOMER.md | 12 ++++++++++-- 1 file changed, 10 insertions(+), 2 deletions(-) diff --git a/docs/SPLAT-NATIVE-CUSTOMER.md b/docs/SPLAT-NATIVE-CUSTOMER.md index 56d5669..0580ed8 100644 --- a/docs/SPLAT-NATIVE-CUSTOMER.md +++ b/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. ---