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Clinical Evaluation Report · EU MDR 2017/745Built for EU MDR requirements and for the way a Notified Body actually reads a clinical evaluation.
Eclevar develops, reviews and remediates Clinical Evaluation Reports, Clinical Evaluation Plans and the clinical evidence packages that surround them, for Class IIa, IIb and III devices. Senior clinical and regulatory specialists, including people who have assessed device files from inside a Notified Body, work on the evidence architecture before the document is written and challenge the package before it is submitted.
A clinical evaluation engagement starts with the regulatory route, the claims, the evidence you already hold and the questions an assessor is most likely to raise. It does not start with a document template. Three situations account for most of the work.
You are building the clinical evaluation from the ground up. Eclevar develops the Clinical Evaluation Plan, sets the evidence strategy and acceptance criteria, establishes the state of the art, runs the systematic literature search and appraisal, writes the Clinical Evaluation Report, and defines the PMCF pathway that keeps it current. One controlled package, one vocabulary, one set of claims.
Legacy evidence assembled under the directives rarely survives contact with Annex XIV unchanged. Eclevar reassesses the claims, tests whether an equivalence route still holds, rebuilds the state of the art and the appraisal against MDR expectations, maps clinical evidence to the relevant GSPRs, and identifies what has to be generated post-market rather than argued.
An assessment has raised findings on the clinical evaluation and the response window is running. Eclevar maps each finding to its root cause rather than to its wording, rebuilds the sections that cannot be defended, harmonizes the linked documents so the response does not create a new contradiction, and prepares the response package.
These are the patterns we are asked to fix most often. They are recurring problems we encounter in the files we are brought into, not a statement of how every assessment goes.
Addressing one of these in isolation often leaves the underlying structure unchanged, which is why the next round of questions tends to land somewhere else in the same file. That is why the work starts with the evidence architecture.
Published program examples state only the delivery scope verified against the underlying engagement documentation.
Nihon Kohden
Neurological diagnostic device
The program required a defensible clinical evidence package for a neurological diagnostic system combining electromyography, nerve-conduction assessment and evoked-potential measurement. Eclevar set the clinical evaluation strategy, authored the Clinical Evaluation Report, and built the literature review, state-of-the-art assessment and data appraisal that support it as one controlled package.
The system records and measures nerve and muscle signals. It is a diagnostic clinical-neurophysiology platform and does not deliver therapeutic neurostimulation.
Public scope is limited to activities verified against the contract and the delivered documentation.
The clinical evidence package was prepared to support the manufacturer's conformity assessment under Regulation (EU) 2017/745. No certification, approval or conformity-assessment outcome is attributed to Eclevar.
Eclevar supports global medical device manufacturers with clinical evaluation, clinical evidence strategy and EU MDR programs across multiple therapeutic areas.
Nihon Kohden
Clinical evaluation and EU MDR evidence
Terumo
Selected client collaboration
Shofu
Selected client collaboration
Engagement scope varies by manufacturer. Case-specific services are described where applicable.
Every deliverable below is built from the same controlled evidence, the same claims and the same terminology, so the dossier reads as one system.
Not every engagement needs all of it. The scope is set after the first review of what you already hold.
Six steps. The evidence decisions and the final challenge are led by senior specialists, not delegated after a kick-off call.
Confirm the regulatory route, intended purpose, claims, device and variant scope, the evidence you hold and any findings already raised.
Define the clinical benefit, the performance and safety parameters, the acceptance criteria and the state-of-the-art benchmark, then map the gaps against them.
Develop or rebuild the CEP, the literature methodology and appraisal, the CER and the PMCF linkage as one package.
A specialist with Notified Body review experience reads the package the way an assessor would, and the likely questions are documented and answered before submission.
Align claims, terminology, data, risk-management references, IFU, PMCF and GSPR support across the dossier.
Support clarifications and deficiency responses within the agreed assessment scope.
Figure 2. Reviewer challenge model
Sponsor evidence
What you already hold: claims, literature, prior data, existing documents.
Eclevar clinical evaluation
Evidence architecture, acceptance criteria, appraisal and authoring.
Reviewer challenge
Cross-document harmonization
Claims, risk file, IFU, PMS, PMCF and SSCP brought into one trace.
Submission
The package goes out with its known weak points already answered.
A clinical evaluation is assessed alongside the risk management file, the IFU and labeling, the PMS and PMCF documentation, the SSCP where one is required, and the GSPR checklist. Inconsistencies between those documents can trigger reviewer questions or findings, and they weaken the defensibility of the clinical evidence package as a whole. It is also why a deficiency response written in isolation can create a fresh inconsistency somewhere else while closing the item it was written for.
Eclevar maintains one claim set and one evidence trace across those documents, and reviews the linked file whenever the CER changes.
Figure 1. Clinical evidence architecture
Device and intended purpose
The population, the indication and the conditions of use that scope the whole evaluation.
Claims
Every performance, safety and clinical-benefit claim that has to be supported, including those in the IFU and the marketing material.
State of the art
The benchmark the device is judged against, including alternative treatments and current clinical practice.
Clinical evidence and appraisal
The literature and clinical data, appraised against a documented and reproducible method.
Acceptance criteria
Set before the analysis, so the report tests the evidence against a standard rather than announcing a conclusion.
Benefit-risk
Derived from the appraised data and the state of the art, not asserted on top of them.
Clinical Evaluation Report conclusion
What the evidence supports and, just as importantly, what it does not.
PMCF and post-market surveillance feed back into the chain. The gaps the report identifies are what the PMCF plan is built to close, and new post-market data reopens the appraisal.
The evidence strategy and the final challenge review are led by named senior people.
COO and CMO Cardiovascular · Consultant cardiac surgeon · Former Notified Body review experience at TÜV SÜD, cardiovascular devices
Applies that experience to clinical evidence strategy, pre-submission challenge and difficult deficiency responses.
Decisions he leads: the evidence route, reviewer-question mapping, the final challenge review, cardiovascular appraisal and response strategy.
Orthopedic surgeon · Former Notified Body review experience at TÜV SÜD, orthopedic and Class III implantable devices
Applies that experience to orthopedic and spine evidence strategy, high-risk implant appraisal and deficiency-response support.
Decisions he leads: orthopedic and spine appraisal, implant evidence review, state-of-the-art benchmarking and specialty input to reviewer responses.
Head of Medical Writing
Clinical evaluation methodology, literature strategy, evidence architecture and regulatory gap analysis across therapeutic areas.
Decisions he leads: methodology, the literature search protocol, authoring, traceability and the integration of CER evidence gaps into PMCF activities.
Notified Body experience is professional background, not a medical qualification, and the two are stated separately above. Former positions are given for biographical context only. Eclevar is independent and is not affiliated with or endorsed by TÜV SÜD or any Notified Body. Meet the full leadership team.
The evidence question is not the same for a coronary guidewire, an orthopedic implant, a dental restorative, a diagnostic platform and a product without an intended medical purpose. The state of the art, the endpoints and the acceptable evidence route all change.
Guidewires, vascular access, structural heart and interventional devices.
Implants, instruments and long-term evidence strategies where survivorship is the endpoint.
Chronic wound, biologic and regenerative device evidence routes.
Active implantables, stimulation systems and neurodiagnostic platforms.
Restorative, implant and dental technology clinical evaluation.
Performance, indirect clinical benefit and evidence for products without an intended medical purpose.
A deficiency letter is a scoping document. Findings frequently point at a structural weakness wider than the sentence they were raised against, and the response window is fixed by the assessing body. Eclevar starts by separating the findings that need a rewrite from the findings that need evidence, because those two answers have very different costs and timelines.
Figure 3. CER remediation pathway
Finding raised
The wording of the finding, and the section it was raised against.
Root cause
What in the evidence architecture produced it, which is rarely the sentence that was quoted.
Scope of the underlying gap
Everything else that follows from the same weakness, including items not yet raised.
Argument or new data
Made explicitly, and made early. Everything downstream depends on which side of this line a finding falls.
The evidence exists but was not presented, appraised or traced in a way that supports the conclusion.
No available evidence closes the gap, so the answer is a PMCF activity or a clinical investigation.
CER and CEP remediation
The sections that cannot be defended as written are rebuilt rather than patched.
Dossier harmonization
The rest of the dossier is realigned to the rebuilt sections.
Response package
Structured to the assessing body's format, finding by finding.
A CER can only conclude on the evidence that exists. When the evaluation identifies a gap that no literature can close, the answer is a study, and the two pieces of work should be planned by the same team.
Yes. The engagement covers the Clinical Evaluation Plan, the evidence strategy, the state of the art, the literature search protocol and appraisal, the report itself and the PMCF linkage, as one package rather than as separate deliverables.
Yes. This is a substantial part of the work. It starts with root-cause analysis of the findings and an explicit decision on which gaps can be closed by argument and which need data.
Yes. For Class III and implantable devices, the clinical evidence strategy must first determine whether a clinical investigation is required or whether one of the conditions or exemptions under Article 61(4) to (6) applies. The applicable route depends on the device, its regulatory history and the clinical evidence available. Eclevar establishes that route before the CER evidence strategy is built.
Yes, where the underlying structure holds. The first step is a review that establishes which of the two it is, because presenting a rewrite as an update is itself a finding risk.
Yes, and it is the preferred route. A CER written against a plan that was not designed for it is one of the most common sources of internal inconsistency.
Yes, with a documented, reproducible search protocol and a traceable path from the result set to the conclusions.
Yes. The work usually turns on whether the legacy claims and any equivalence route survive Annex XIV, and on what has to move into post-market evidence generation.
Yes. A senior challenge review reads the package against assessment logic and documents the questions the package is most likely to attract, with the evidence available to answer them. Cross-document consistency is a defined part of that scope, not an optional review at the end.
Named senior specialists, including people with Notified Body review experience and practicing clinicians in the relevant specialty. The people listed above lead the decisions set out against their names.
Tell us the device class, the regulatory situation and where you think the evidence is thin. We will route the conversation to the reviewer and the therapeutic specialist relevant to your file.
Client program cards describe the delivery scope verified against the contract and the delivered documentation for that engagement, and nothing beyond it. No certification, approval or conformity-assessment outcome is attributed to Eclevar. Eclevar is a clinical research and regulatory services provider. Conformity assessment and certification decisions are made by the Notified Body.
