Clinical Review: Round 1
Status
Key changes verified in source docs
| Description | Item | Assigned |
|---|---|---|
| Device description rewritten as stand-alone in CER | Item 2a | Taig |
| Device output explained as ICD-11 probability distribution | Item 2a | Taig |
| How-to-read-this-CER section in R-TF-015-003 | Item 2a | Taig |
| API vs physician prioritised view distinction in CER | Item 2a | Taig |
| Clinical benefits consolidated from 7 to 3, Option C | Item 2b | Taig |
| Acceptance criteria derived from SotA in CER | Item 2b | Taig |
| Individual acceptance criteria for high-risk conditions in CER | Item 2b | Taig |
| MRMC reframed as Rank 11 supporting evidence in CER | Item 3a | Taig |
| Equivalence section expanded with 4 specific changes in CER | Item 3a | Taig |
| Sample size justification and sufficiency section in CER | Item 3b | Taig |
| Usability section in CER with methodology, results, residual risk | Item 4 | Taig |
| Gaps 4 and 5 declared acceptable in CER Need for more evidence | Item 6 | Taig |
| DIQA traceability found: SRS-Y5W with 11 test cases | Item 7 | Taig |
| IFU gap fixed: population variability section added | Item 7 | Taig |
| N3 complete: all 62 risks have full traceability | Item 7 | Taig |
| PMS section rewritten: MDCG 2020-6 § 6.2.2 cited, future-tense fixed, PSUR deprecated | CER | Taig |
| PMCF activity pruning: team decided NOT to remove any activities, 2026-04-07 | Item 6a | Jordi |
Source column renamed: "Source" → "Source of Acceptance Criteria", "Sample" → "Current study", "Population" → "State of the art" in PerformanceClaimsTable.tsx | Item 2b | Taig |
| Validated methodological quality appraisal section added: QUADAS-2 (4 studies), MINORS (6 studies), per-study prose | Item 3a | Jordi |
| Regulatory framework, evidence quality hierarchy (MDCG 2020-6 App. III), and MDCG 2020-1 three-pillar tables added to CER | Item 3a | Jordi |
| CRIT1-7 appraisal framework rationale added to SotA (R-TF-015-011) | Item 3a | Jordi |
| CRIT1-7 mapped to MDCG 2020-6 § 6.3 tools (IMDRF Appendix F, Newcastle-Ottawa Scale, GRADE) in SotA | Item 3a | Jordi |
| CRIT1-7 replaced by MINORS for 9 manufacturer studies and 4 severity publications in CER appraisal sections | Item 3a | Jordi |
| MINORS appraisal for severity validation studies (APASI_2025, AUAS_2023, AIHS4_2023, ASCORAD_2022) added to CER | Item 3a | Jordi |
| New "Clinical evidence strategy and regulatory methodology" section added to CER: Routes A/B/C, 3 pillars, Appendix III | Item 3a | Jordi |
| MEDDEV stages 0–3 updated with per-stage outcome sentences in CER | Item 3a | Jordi |
| Item 3a response updated: item 10 added (strategy section reference), item 7 updated (4th study design family) | Item 3a | Jordi |
| NMSC_2025 (Medela et al. 2025) added as Pillar 3 Clinical Performance malignancy evidence: QUADAS-2 appraisal, prose analysis, and "Appraisal of published malignancy clinical evidence" section added to CER; response items 5, 7, 9, 10 updated | Item 3a | Jordi |
| CER purged of all old benefit IDs: "7 distinct clinical benefits" → 3 benefits; 1QF→7GH (4 rows + 2 prose references), 8PL→3KX (1 row + 1 prose reference), 0ZC→3KX (3 rows), N/A→3KX (Expert Agreement row), 9VW→7GH sub-criterion (b) | CER | Jordi |
| CER gaps 1–5 annotated with benefit IDs; CEP gap list updated with benefit annotations; PMCF activity rationales (A.1–A.3, B.1, B.4, B.5, C.1, Section D heading) updated to cite specific clinical benefits | CER/PMCF/CEP | Jordi |
| Concordance review of 4 severity publications: 6 errors fixed — ASCORAD annotators (3→9), ASCORAD RMAE values, APASI annotator characterisation, AUAS subjects (248→231), AUAS year, combined totals (3,300→4,400 images, 17→24 dermatologists), data file author order | Item 3 | Taig |
Source document verification audit (2026-04-06, updated 2026-04-18)
A systematic audit previously flagged that multiple responses referenced changes that did not exist in the source documents. All originally identified blockers have now been resolved: (1) PMCF Plan Section D resolved 2026-04-07 (commit c289ff136 added Section D with D.1/D.2). (2) AI Risk Assessment Item 7 updates resolved 2026-04-18: strategy pivoted from updating R-TF-028-011 JSON fields to (a) adding severity justification and likelihood methodology sections to R-TF-013-003, (b) adding AI-vs-patient-harm scale reconciliation section to R-TF-028-011 MDX, (c) citing concrete PMS numerators/denominators from the legacy device PMS Report (R-TF-007-003, superseding the deprecated R-TF-007-004) with IMDRF N56 Appendix F appraisal in the response. (3) CER PMS section resolved 2026-04-07: PSUR deprecated (Class IIa/IIb format incompatible with Class 1 device); CER PMS section rewritten with MDCG 2020-6 § 6.2.2 citation and fixed future-tense language; responses corrected to remove PSUR-sourced data. See the full audit at item-0/verification-audit-2026-04-06.
Overview
This section documents the items raised by BSI during the Round 1 Clinical Oversight Review for the device, version 1.1.0.0.
| Field | Value |
|---|---|
| Assessment reference | T0088560 |
| BSI job reference / SMO | 30365821 |
| Reviewer | Erin Preiss, Clinical Evaluation Specialist |
| Round 1 sent | 2026-03-06 |
| Response deadline | TBD |
| Status | Received |
Summary of items
This round contains 7 items with a total of 10 requests. Items 2, 3, and 6 are flagged as deficiencies.
Items with deficiency finding
| Item | Topic | Requests | Key area |
|---|---|---|---|
| Item 2 | Device Description & Claims | 2 | Annex II, Annex XIV 1(a) sub-bullets 2, 3, 4, 6; Article 2(53): intended purpose, OZCs, SotA |
| Item 3 | Clinical Data | 2 | Annex XIV, Article 61: clinical assessment completeness, CIs, equivalence, PMS data |
| Item 6 | PMCF Plan | 2 | Annex XIV 5, 6.1, 6.2: PMCF activity detail, justification, lifetime coverage |
Items without deficiency finding (observations/requests)
| Item | Topic | Requests | Key area |
|---|---|---|---|
| Item 1 | CER Updates | 1 | Articles 61(11), 86: CER update frequency cadence |
| Item 4 | Usability | 1 | GSPR 5, EN ISO 14971: summative usability validation methodology/results |
| Item 5 | PMS Plan | 1 | Chapter VII Articles 83–89, Annex III 1(a)(b): PMS SOPs and traceability |
| Item 7 | Risk | 1 | GSPRs 1–5, 8: severity justification, occurrence estimates, residual risk |
Response process
As per BSI's instructions:
- Responses must be appended below each question in BSI's Word document
- Supplementary evidence should be compiled as a single bookmarked PDF
- Red-lined documentation should be provided for any document changes
- Specific section/page references should be provided wherever information has been added or updated
BSI notes
- During the initial review, significant gaps were identified which prevented in-depth review of some parts of the clinical evaluation as scope could not be well understood prior to definition of some key parameters. As a result, a high-level review was performed of some sections, with cursory questions provided. More in-depth and unrelated questions may be asked during later rounds after scope is defined.
- Examples provided should not be considered exhaustive. Efforts should be made to comprehensively address all gaps.
Applicable requirements
The items reference the following regulatory requirements and standards:
- MDR 2017/745 Article 2 (Definitions): (48) clinical data, (51) clinical evidence, (53) clinical benefit
- MDR 2017/745 Article 7: Prohibition of misleading claims
- MDR 2017/745 Article 61: Clinical evaluation
- MDR 2017/745 Article 86: PSUR update frequency
- MDR 2017/745 Articles 83–89: Post-market surveillance and vigilance
- MDR 2017/745 Annex I (GSPRs): 1, 2, 3, 4, 5, 8
- MDR 2017/745 Annex II: Device description and technical documentation requirements
- MDR 2017/745 Annex III: 1(a), 1(b): PMS technical documentation
- MDR 2017/745 Annex XIV: Clinical evaluation and PMCF requirements
- EN ISO 14971:2019 + A11:2022: Application of risk management to medical devices
- MDCG 2020-7: PMCF plan guidance