docs(splat-native): address review feedback on #34 (IVD-MDR → MDR Annex VIII Rule 11)#35
Merged
Merged
Conversation
…ex 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.
This file contains hidden or bidirectional Unicode text that may be interpreted or compiled differently than what appears below. To review, open the file in an editor that reveals hidden Unicode characters.
Learn more about bidirectional Unicode characters
Sign up for free
to join this conversation on GitHub.
Already have an account?
Sign in to comment
1 participant
Add this suggestion to a batch that can be applied as a single commit.This suggestion is invalid because no changes were made to the code.Suggestions cannot be applied while the pull request is closed.Suggestions cannot be applied while viewing a subset of changes.Only one suggestion per line can be applied in a batch.Add this suggestion to a batch that can be applied as a single commit.Applying suggestions on deleted lines is not supported.You must change the existing code in this line in order to create a valid suggestion.Outdated suggestions cannot be applied.This suggestion has been applied or marked resolved.Suggestions cannot be applied from pending reviews.Suggestions cannot be applied on multi-line comments.Suggestions cannot be applied while the pull request is queued to merge.Suggestion cannot be applied right now. Please check back later.
Summary
Follow-up to PR #34 (merged). Addresses one codex P2 finding on the regulatory citation.
Fix
The §4 standards / vocabularies index in
docs/SPLAT-NATIVE-CUSTOMER.mdcited "IVD-MDR Rule 11" as the EU SaMD risk classification for splat-native ultrasound. This is the wrong regulation.Because §4 is the regulatory cross-reference future D-SPLAT-14 (SaMD documentation track) work follows, leaving the wrong regulation name would send the certification/evidence plan down the wrong rule set for the stated ultrasound device. The Class IIa classification claim itself was correct; only the regulation citation was wrong.
What this PR changes
docs/SPLAT-NATIVE-CUSTOMER.md§4 last bulletIVD-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) [...] IVDR 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.Companion fix landing in the lance-graph canonical plan (PR follow-up to #471) — the same wrong citation appeared in the D-SPLAT-14 row of both the plan body and the STATUS_BOARD.
What's NOT in this PR
Test plan
Companion follow-up PRs:
lance-graphclaude/splat-native-ultrasound-v1-fixes — 5 fixes (StepDomain, STATUS_BOARD canonical status, pose_se3 16→24, NR-SPLAT-PHI normative rule, MD040 fence tags, + same IVD-MDR consistency fix)ndarrayclaude/splat-native-ultrasound-v1-fixes — 2 fixes (opacity-blend ray segmentation, Mahalanobis scratch buffer)MedCare-rsclaude/splat-native-ultrasound-v1-fixes — 1 fix (pose_se3 16→24)OGAR(this PR)