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Clinical Evaluation Report · EU MDR 2017/745

Clinical Evaluation Report (CER) services for medical devices

Built 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.

  • Reviewer challenge before submission. Your package is read against assessment logic, so you see the questions it is likely to attract while you can still answer them.
  • Class IIa through Class III. Evidence strategy matched to device risk, indication and the route you can actually defend.
  • Authoring and remediation. First MDR submissions, MDD to MDR transitions, and deficiency responses after an assessment has already gone badly.
Engagement scenarios

Senior support matched to your regulatory situation

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.

01. First MDR CER submission

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.

Discuss a first MDR submission

02. MDD to MDR transition

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.

Discuss a transition file

03. Notified Body deficiency response

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.

Review a deficiency letter

Problem recognition

Where clinical evaluations usually break

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.

  • Claims in the IFU and the marketing material that the clinical evidence supports for only part of the intended population.
  • An equivalence claim built on a device whose data the manufacturer cannot access, or one where the technical, biological and clinical criteria are asserted rather than demonstrated.
  • A state of the art written as a literature summary rather than as the benchmark the device is judged against.
  • Acceptance criteria that appear for the first time in the conclusion, so nothing in the report is actually measured against them.
  • A literature search protocol whose inclusion and exclusion logic does not reproduce the result set presented.
  • A benefit-risk conclusion asserted on top of the data rather than derived from it.
  • PMCF treated as an appendix rather than as the answer to the evidence gaps the report itself identified.

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.

Client programs

Clinical evaluation programs delivered for medical device manufacturers

Published program examples state only the delivery scope verified against the underlying engagement documentation.

Nihon Kohden Neurological diagnostic device

EU MDR clinical evidence for an electromyography and evoked-potential system

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.

Generic clinical-neurophysiology workstation: display cart, amplifier and electrode leads
  • Electromyography
  • Nerve conduction
  • Evoked potentials
Electromyography and evoked-potential measuring system Clinical neurophysiology, neurological diagnostic device. Proprietary illustration built on generic device-category geometry. No client product photograph, traced outline or model designation is used.

Verified delivery scope

  • Clinical evaluation strategy
  • Clinical Evaluation Report
  • Systematic literature review
  • State-of-the-art assessment
  • Clinical-data appraisal
  • EU MDR evidence integration

Public scope is limited to activities verified against the contract and the delivered documentation.

Regulatory purpose

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.

Trusted by global medical device manufacturers

Eclevar supports global medical device manufacturers with clinical evaluation, clinical evidence strategy and EU MDR programs across multiple therapeutic areas.

  • Eclevar and Nihon Kohden team members photographed together at a working meeting
    Nihon Kohden Clinical evaluation and EU MDR evidence
    • CER
    • Literature review
    • State of the art
  • Eclevar and Terumo team members photographed together at a working meeting
    Terumo Selected client collaboration
  • Eclevar and Shofu team members photographed together at a working meeting
    Shofu Selected client collaboration

Engagement scope varies by manufacturer. Case-specific services are described where applicable.

What we deliver

One clinical evidence architecture, not a stack of documents

Every deliverable below is built from the same controlled evidence, the same claims and the same terminology, so the dossier reads as one system.

  • Clinical Evaluation Plan and Clinical Development Plan
  • State of the art and alternative-treatment analysis
  • Systematic literature search protocol review and appraisal, with a reproducible method
  • Clinical Evaluation Report authored or remediated
  • Equivalence strategy and Article 61 justification, where applicable
  • Benefit-risk analysis and clinical GSPR mapping
  • PMCF Plan and PMCF Evaluation Report derived from the evidence gaps the CER identifies
  • SSCP clinical content consistent with the CER conclusions
  • Cross-document consistency review across CER, risk management, IFU, PMS and SSCP
  • Notified Body deficiency responses and submission support

Not every engagement needs all of it. The scope is set after the first review of what you already hold.

Reviewer-led delivery model

How the engagement runs

Six steps. The evidence decisions and the final challenge are led by senior specialists, not delegated after a kick-off call.

  1. Strategy and deficiency mapping

    Confirm the regulatory route, intended purpose, claims, device and variant scope, the evidence you hold and any findings already raised.

  2. Evidence architecture

    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.

  3. Integrated authoring

    Develop or rebuild the CEP, the literature methodology and appraisal, the CER and the PMCF linkage as one package.

  4. Reviewer challenge

    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.

  5. Cross-document harmonization

    Align claims, terminology, data, risk-management references, IFU, PMCF and GSPR support across the dossier.

  6. Submission and question support

    Support clarifications and deficiency responses within the agreed assessment scope.

Figure 2. Reviewer challenge model

  1. 01

    Sponsor evidence

    What you already hold: claims, literature, prior data, existing documents.

  2. 02

    Eclevar clinical evaluation

    Evidence architecture, acceptance criteria, appraisal and authoring.

  3. 03

    Reviewer challenge

    • Likely questions documented
    • Evidence gaps declared
    • Response strategy prepared
  4. 04

    Cross-document harmonization

    Claims, risk file, IFU, PMS, PMCF and SSCP brought into one trace.

  5. 05

    Submission

    The package goes out with its known weak points already answered.

The challenge step happens while the answers are still cheap.
Evidence architecture

The CER is read against everything else in your file

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

  • Start

    Device and intended purpose

    The population, the indication and the conditions of use that scope the whole evaluation.

  • 02

    Claims

    Every performance, safety and clinical-benefit claim that has to be supported, including those in the IFU and the marketing material.

  • 03

    State of the art

    The benchmark the device is judged against, including alternative treatments and current clinical practice.

  • 04

    Clinical evidence and appraisal

    The literature and clinical data, appraised against a documented and reproducible method.

  • 05

    Acceptance criteria

    Set before the analysis, so the report tests the evidence against a standard rather than announcing a conclusion.

  • 06

    Benefit-risk

    Derived from the appraised data and the state of the art, not asserted on top of them.

  • CER

    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.

Each element constrains the next. A change to the claims or the intended purpose reopens everything below it.
Who does the work

The people who challenge your clinical evidence

The evidence strategy and the final challenge review are led by named senior people.

Dr Mark Da Costa, Chief Operating Officer and Chief Medical Officer, Cardiovascular, at Eclevar MedTech

Dr Mark Da Costa

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.

Dr. Nikhil Khadabadi, Chief Medical Officer, Orthopedics and Spine, at Eclevar MedTech

Dr. Nikhil Khadabadi

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.

Pierre-Marie Boutanquoi, Head of Medical Writing at Eclevar MedTech

Pierre-Marie Boutanquoi

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.

Therapeutic fit

Clinical evaluation expertise by device and therapeutic area

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.

Deficiency response

You have findings on your clinical evaluation

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.

What the response work covers

  • Root-cause analysis of each finding, including the items that were not raised but follow from the same weakness
  • Rebuild of the CEP or CER sections that cannot be defended as written
  • A decision, made explicitly, on which gaps are closed by argument and which require new data
  • Harmonization of the linked documents so the response does not create a fresh contradiction
  • A structured response package aligned to the assessing body's format

Figure 3. CER remediation pathway

  1. 01

    Finding raised

    The wording of the finding, and the section it was raised against.

  2. 02

    Root cause

    What in the evidence architecture produced it, which is rarely the sentence that was quoted.

  3. 03

    Scope of the underlying gap

    Everything else that follows from the same weakness, including items not yet raised.

  4. 04 · The decision

    Argument or new data

    Made explicitly, and made early. Everything downstream depends on which side of this line a finding falls.

    • Closed by argument

      The evidence exists but was not presented, appraised or traced in a way that supports the conclusion.

    • Requires new data

      No available evidence closes the gap, so the answer is a PMCF activity or a clinical investigation.

  5. 05

    CER and CEP remediation

    The sections that cannot be defended as written are rebuilt rather than patched.

  6. 06

    Dossier harmonization

    The rest of the dossier is realigned to the rebuilt sections.

  7. 07

    Response package

    Structured to the assessing body's format, finding by finding.

Separating findings that need a rewrite from findings that need evidence is the decision that sets the timeline.
Connected work

Where clinical evaluation fits in your evidence program

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.

Before you engage

Questions manufacturers ask before engaging

Can Eclevar write a complete CER from scratch?

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.

Can you remediate a CER after Notified Body findings?

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.

Do you support Class III and implantable devices?

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.

Can you update an existing CER instead of rewriting it?

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.

Can Eclevar develop the CEP and the CER together?

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.

Do you perform systematic literature reviews?

Yes, with a documented, reproducible search protocol and a traceable path from the result set to the conclusions.

Can you support an MDD to MDR transition?

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.

Can you review our CER and align it with PMCF, risk management and the SSCP before we submit?

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.

Who actually works on the file?

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.

Next step

Put your clinical evaluation through a senior review before it is assessed

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.

Scope and limitations

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.

Reforming Clinical Evaluation of Medical Devices in Europe