Adequacy review — MDCG 2020-13 Sections A, B, I, J, K

Purpose and method

Per-criterion adequacy review of R-TF-015-003 against the remaining MDCG 2020-13 sections: A (administrative particulars), B (reviewers involved in the notified-body assessment), I (Article 54 consultation procedure), J (Article 61(10) exception), and K (Article 61(2) voluntary consultation on clinical development strategy). Methodology identical to Section C.

Source documents: MDCG 2020-13 Section A, B, I, J, K; R-TF-015-003 CER.

Reviewer: BSI clinical-auditor reviewing agent. Review baseline commit: 6b8c706d1 (after §G CER + Overall Conclusions fixes land).

Section A — Administrative particulars

A.1 — Device and manufacturer identification fields

Criterion: medical-device name/model/type; risk class; applicable codes per Commission Implementing Regulation (EU) 2017/2185; manufacturer name and SRN; Authorised Representative name and SRN (if applicable); intended purpose; Basic UDI-DI; Certificate number (if applicable).

CER location: Executive summary (line 14+); classification subsection (new in §C.1); Device identification subsection via <ManufacturerDetails /> and <DeviceCharacterisation /> components; Intended purpose via <IntendedPurpose /> component; reference to Annex VIII Rule 11 second indent for classification.

Verdict: Conditional.

Rationale. Device name/type/class are explicit. Manufacturer and Authorised Representative details are rendered via reusable components (which a notified-body reviewer will expect to resolve to explicit SRN numbers). Intended purpose is rendered via the <IntendedPurpose /> component. The CER does not explicitly list applicable MDR codes per Implementing Regulation (EU) 2017/2185, nor record Basic UDI-DI or Certificate number on-face. These are CEAR Section A fields the notified body will transcribe into its own CEAR and that the CER should make visible.

Recommended fix. Anchor: #general-details, add a short "Administrative particulars" subsection at the top listing: (i) the applicable MDR codes from Commission Implementing Regulation (EU) 2017/2185 for the device's intended purpose / technology; (ii) the Basic UDI-DI if assigned; (iii) the Certificate number, where applicable (marked N/A for the initial CE-marking submission and re-verified at each update); and (iv) an explicit reference to the manufacturer SRN and the Authorised Representative SRN as rendered in the <ManufacturerDetails /> component. Primary source: MDR Article 29 (UDI), Article 31 (manufacturer registration), Commission Implementing Regulation (EU) 2017/2185.

A.2 — Type of assessment

Criterion: initial conformity / assessment of changes and update / re-certification / technical-documentation sampling assessment.

CER location: Executive summary line 14+ describes the CER as the first CE-marking submission; line 780 "This product has not been commercialized yet. It is undergoing initial CE mark."

Verdict: Tick.

Rationale. Initial conformity assessment is declared unambiguously; the other three types are implicitly N/A and will be marked accordingly by the notified body in their own CEAR.

A.3 — CER authors: dated, signed, CVs provided

Criterion: CER dated and signed; CVs provided for CER author(s).

CER location: Signature component (<Signature />) on every procedure/record page per QMS convention; #qualification-of-the-responsible-evaluators at line 2488+; #justification-of-the-level-of-evaluators-expertise; Annex I (CVs and declarations of interest).

Verdict: Tick.

Rationale. The Signature component auto-populates author / reviewer / approver from git history and the QMS responsibility matrix; CV details live in the Appendix directory cross-referenced from the CER. Dated signing and CVs are present.

A.4 — Parts of template applied

Criterion: which MDCG 2020-13 sections (A, B, C, D, E, F, G, H, Overall Conclusions; plus Specific Considerations I, J, K) have been applied.

CER location: the adequacy-review index (this directory); the coverage matrix at §2 maps all MDCG 2020-13 sections to CER anchors.

Verdict: Tick (External — the template-parts-applied question is answered by the coverage matrix plus this adequacy-review directory).

Rationale. The coverage matrix and this adequacy-review directory together document which MDCG 2020-13 sections have been applied and where they are addressed in the CER.

Section B — Reviewers involved in the notified-body assessment

Criterion: name or employee code of personnel with relevant clinical expertise per Annex VII §3.2.4; additional reviewers; competence areas per Annex VII §3.3.2.

Verdict: N/A (notified-body side).

Rationale. Section B is filled in by the notified body during their own CEAR. The manufacturer-side analogue — the roster of CER authors and their qualifications — is documented at #qualification-of-the-responsible-evaluators (line 2488+) and in Annex I (CVs and declarations of interest).

Section I — Clinical-evaluation consultation procedure (Article 54)

Criterion: is the procedure required by Article 54(1) to be applied? If not, which Article 54(2) exception applies?

CER location: classification subsection (new in §C.1) identifies the device as Class IIb MDSW under MDR Annex VIII Rule 11 second indent, non-implantable.

Verdict: N/A — Article 54 does not apply.

Rationale. Article 54(1) applies only to Class III implantable devices and to Class IIb active devices intended to administer or remove a medicinal product. The device under evaluation is a Class IIb non-implantable, non-active-medicinal-administration MDSW under Rule 11 second indent. The Article 54 clinical-evaluation consultation procedure is therefore not triggered.

Recommended fix (clarifying N/A statement). Anchor: #methodology (line 295+) or #scope-of-the-clinical-evaluation — add a short paragraph. Insert: "MDR Article 54 clinical-evaluation consultation procedure. Article 54(1) does not apply to this device. Article 54(1) applies only to Class III implantable devices and to Class IIb active devices intended to administer or remove a medicinal product. The device under evaluation is a Class IIb non-implantable medical device software under MDR Annex VIII Rule 11 second indent and does not fall within the Article 54(1) scope. No consultation procedure has been initiated and no expert-panel opinion has been solicited under Article 54; accordingly, sub-items (a), (b), and (c) of Article 54(2) are not engaged." Primary source: MDR 2017/745 Article 54(1) and Article 54(2).

Section J — Article 61(10) exception

Criterion: has the manufacturer claimed that demonstration of conformity with GSPRs based on clinical data is not deemed appropriate per Article 61(10)?

CER location: section Clinical evidence strategy and regulatory methodology at line 180+ presents a clinical-data-based strategy (MDCG 2020-6 + MEDDEV 2.7.1 Rev 4 + MDCG 2020-1); the three-pillar evidence framework is actively engaged; nine pivotal clinical investigations have been conducted.

Verdict: N/A — Article 61(10) is not invoked.

Rationale. The CER demonstrates conformity based on clinical data as defined by MDR Article 2(48), using the full three-pillar MDSW framework (Valid Clinical Association, Technical Performance, Clinical Performance). Article 61(10) — the exception for cases where clinical-data-based conformity demonstration is not deemed appropriate — is not invoked.

Recommended fix (clarifying N/A statement). Anchor: #clinical-evidence-strategy-and-regulatory-methodology, add at the start of the subsection or immediately before #regulatory-basis-and-evaluation-mandate. Insert: "MDR Article 61(10) exception. Article 61(10) is not invoked for this device. Demonstration of conformity with the applicable General Safety and Performance Requirements (GSPR 1, GSPR 8, GSPR 17) is based on clinical data as defined by MDR Article 2(48), presented in this CER within the three-pillar MDSW framework of MDCG 2020-1 (Valid Clinical Association; Technical Performance; Clinical Performance). The evidence base comprises nine pre-market pivotal clinical investigations, the equivalent legacy device's post-market real-world evidence, five peer-reviewed published validation studies, and a systematic SotA literature review." Primary source: MDR 2017/745 Article 61(10); MDR Article 2(48); MDCG 2020-1.

Section K — Article 61(2) voluntary consultation on clinical development strategy

Criterion: has a voluntary clinical-development-strategy consultation been requested under Article 61(2)? Expert-panel recommendations; divergence from manufacturer strategy.

CER location: no reference to any Article 61(2) voluntary consultation in the CER.

Verdict: N/A — no voluntary consultation was requested.

Rationale. Article 61(2) is a voluntary mechanism available to manufacturers of certain Class III and Class IIb implantable devices. The manufacturer has not requested this consultation for the device under evaluation; none of the clinical development strategy decisions documented in the CEP and CER arose from such a consultation.

Recommended fix (clarifying N/A statement). Anchor: same location as the Article 61(10) N/A statement above (#clinical-evidence-strategy-and-regulatory-methodology). Insert: "MDR Article 61(2) voluntary consultation. No voluntary clinical-development-strategy consultation under Article 61(2) has been requested for this device. Article 61(2) is a voluntary mechanism for certain Class III and Class IIb implantable devices; the device under evaluation is a Class IIb non-implantable MDSW and the manufacturer has not initiated this procedure." Primary source: MDR 2017/745 Article 61(2).

Sections A/B/I/J/K overall

MDCG 2020-13 section	Verdict	One-sentence rationale
§A Administrative particulars	Compliant with minor non-compliance	A.2 / A.3 / A.4 Tick; A.1 Conditional — add MDR codes per Implementing Regulation 2017/2185, Basic UDI-DI, and Certificate-number placeholder under a new Administrative particulars subsection.
§B Reviewers (NB side)	N/A	Completed by the notified body; manufacturer roster is in #qualification-of-the-responsible-evaluators.
§I Article 54 consultation	N/A	Class IIb non-implantable, non-active-medicinal-administration device; Article 54(1) does not apply. Explicit statement to be added.
§J Article 61(10) exception	N/A	Conformity demonstrated via clinical data under the MDCG 2020-1 three-pillar MDSW framework; Article 61(10) exception is not invoked. Explicit statement to be added.
§K Article 61(2) voluntary consultation	N/A	No voluntary clinical-development-strategy consultation requested. Explicit statement to be added.

Roll-up. Sections A/B/I/J/K are Compliant with minor non-compliance overall. 3 Ticks and 1 Conditional for §A (A.1 administrative-particulars fields need surfacing on-face); 4 explicit N/A statements to be added to the CER for §B (external to manufacturer), §I, §J, and §K. All fixes are concise insertions at identified anchors.