Eclevar Medtech eliminates the root causes of Notified Body non-conformities before the first draft reaches the reviewer. We build clinical evidence that closes the cycle in one round.
More than two-thirds of Class IIb and Class III CER submissions under EU MDR receive a Major NCR. Issues range from insufficient safety evidence to missing PMCF feedback loops.
Each Q&A round adds 3-4 months. For many, cumulative delays exceed 9 months, resulting in massive lost market access for every month the device is not on the shelf.
Lack of traceable Annex XIV residual risk-to-clinical evidence mapping.
Equivalence claimed without similarity demonstrated.
PMCF Plan not linked to CER gaps.
Literature methodology fails MEDDEV 2.7/1 standards.
No state-of-the-art benchmark defined.
Building Backwards from the Notified Body Checklist. Every CER Eclevar authors is built against the same checklist that your Notified Body uses. Our team includes former reviewers who have assessed hundreds of packages. They know exactly which evidence gaps trigger a Major NCR.
Pierre-Marie is a senior expert with deep expertise in methodology for high-risk cardiovascular devices. Former assessor for Class III packages, he builds documents the way a reviewer needs to read them.
Mark specializes in shortening the Q&A cycle through structured pre-submission alignment meetings and proactive gap analysis before the first submission. Expert in NB relationship management.
Former assessor at TUV SUD. Nikhil has assessed clinical evidence for hundreds of implants from the reviewer side. He writes CERs against the exact internal assessment frameworks of major NBs.
We build a complete matrix mapping every CER residual risk to a specific clinical evidence source. Notified Bodies cannot find a gap because there are no gaps.
We build the full three-dimensional similarity matrix (technical, biological, clinical) before equivalence is claimed. No assertion is made without documentation.
Full MEDDEV 2.7/1 Section 9 compliance: predefined strategy, explicit inclusion/exclusion, PRISMA flow, and study appraisal with NICE or GRADE. No cherry-picking.
Each PMCF objective is derived directly from a specific evidence gap identified in the clinical evaluation. The PMCF Plan and CER are two sides of a single document.
| NCR Reference | Root Cause | Eclevar Solution |
|---|---|---|
| Equivalence inadequate (Art. 61(4)) | Similarity not demonstrated per MDR Article 61(4). | Full 3D similarity matrix built before claim. |
| SLR fails MEDDEV 2.7/1 rev.4 | No PRISMA flow; narrative review only. | Section 9 compliant SLR with GRADE appraisal. |
| No PMCF-to-CER gap linkage | PMCF Plan authored independently. | PMCF Plan co-authored with direct gap mapping. |
| SSCP inconsistent with CER | Performance data values do not match conclusions. | Documents co-authored from verified source documents. |
Pre-evaluation definition of SoA for the device category, establish benchmarks before search begins.
MEDDEV 2.7/1 Section 9 compliant review with PRISMA flow and GRADE/NICE appraisal.
Full Article 61(4) coverage for technical, biological, and clinical similarity.
Critical appraisal of device-specific data (Investigations, PMCF, Registries).
Full MEDDEV 2.7/1 rev.4 authoring with embedded Annex XIV traceability matrix.
Co-authored deliverables to ensure 100% internal consistency across all documents.
Free 30-min call to identify NB risks and map pathway.
Build traceability and SoA benchmark before finalize strategy.
Section 9 SLR and comprehensive clinical data appraisal.
Draft CER reviewed by second expert against NB checklist.
Manage NB cycle until final approval is achieved.
Book a free Clinical Evaluation Report Gap Assessment. We will review your current evidence and outline exactly what is required to achieve approval in a single round.
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