Clinical Review: Round 1
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