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Common Non Conformities in
MDR Clinical Evaluation

Dr. Nikhil Khadabadi

Clinician-led excellence in clinical evidence and MDR compliance

TÜV SÜD Ex TÜV SÜD Clinical Reviewer MDR PMCF Expert

"With over 15 years of experience across orthopaedic surgery, notified body review and industry, I bring frontline medical and regulatory insight to every evidence program. We focus on clinical data that is clear, defendable and ready for review."

— Dr Nikhil Khadabadi, MD, MS, MRCS
"I have sat on both sides of the table. I have reviewed clinical files for a Notified Body and authored them for manufacturers. Most nonconformities are predictable and preventable once you know how reviewers think. My simple advice is: keep a clean structure that is searchable, traceable, and defensible."
Area 01

General clinical documentation quality

"The CER is only partially searchable and lacks bookmarks or clickable contents. Updated sections are not provided with tracked changes, making review difficult."

Frequent Issues

  • CER and CEP files are not fully searchable
  • No clickable table of contents or bookmarks
  • Updated documents sent without a tracked changes version
  • Author CVs and DOIs are missing or out of date
  • Gap between literature search cut off and submission is too long

Practical Fixes

  • Make every document fully searchable with bookmarks
  • Always submit tracked and clean versions together
  • Add a short Pathway Statement in section one
  • Keep an Author Dossier with signed CVs and DOIs
  • Align search cut-offs with device risk
Area 02

Managing device families and variants

"The CER puts nine device models into one report without explaining the differences between them or how each one is supported."

Frequent Issues

  • Multiple models included without clear model-level support
  • Evidence pooled across sizes or indications with no explanation
  • Worst-case variants used without scientific justification
  • No device family map linking models to data

Practical Fixes

  • Build a Device Family Matrix listing configurations
  • Provide a short bridging justification for highest-risk models
  • Mark every clinical claim as Family-level or Model-specific
  • Explain similarity testing when a model lacks direct data
Nihon Kohden
Client Success Story

Nihon Kohden Corporation

"Eclevar provided thorough explanations about document preparation policy and relevant guidelines, sharing their expertise in a way that allowed us to create documentation perfectly adapted to our situation. The team responded promptly and arranged meetings in a timely manner."

Y.G., Product Manager for EEG-1200K
Area 03

Clinical Evaluation Plan essentials

"The CEP lists 'improve outcomes' as the main clinical benefit for a Class IIb implant but does not define measurable outcomes or acceptance thresholds."

Frequent Issues

  • Intended purpose is vague and not certificate ready
  • Clinical benefits are written as general intentions
  • Benefit-risk acceptance thresholds are missing
  • CEP and CER are not aligned on outcome parameters

Practical Fixes

  • Write a clear purpose statement fit for the certificate
  • Convert each benefit into measurable outcomes
  • Define acceptance thresholds based on state of the art
  • Ensure the CER uses the same outcomes as the CEP
Area 04

State of the art that truly drives thresholds

"The CER provides a long background on the disease but does not define outcome ranges. The device cannot be compared to any concrete benchmark."

Frequent Issues

  • Section reads like a textbook rather than an evidence review
  • Safety outcomes described narratively, not turned into numbers
  • No explicit acceptance ranges defined
  • CEP does not reuse these ranges as thresholds

Practical Fixes

  • Create a focused, separate State of the Art section
  • Turn alternative outcomes into numeric ranges
  • Copy these thresholds into the CEP
  • Compare device data directly against these thresholds in the CER

Self score: Are you review ready?

Give yourself two points for each Yes and zero for each No.

  • Can a reviewer reach your acceptance thresholds from the state of the art in under 1 minute?
  • Do your PMCF endpoints mirror your CEP outcomes?
  • Does every clinical claim point to a cited paragraph in the CER?
  • Does your device family matrix prove coverage for each model?
  • Can you show signed author CVs and DOIs less than 12 months old?

Your Score

8 to 10: You are ready for scrutiny.

5 to 7: Tighten your alignment.

0 to 4: Rebuild your core evidence logic.

Partnership Success Story

RegenLab: Chronic Wound Trial

"With Milo, we transformed the way data becomes clinical data across multiple sites, ensuring high-quality, real-time capture and seamless integration with clinical workflows. This has significantly improved data accuracy and regulatory compliance in our trials."

Watch Now
RegenLab

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Dr Nikhil

Dr. Nikhil Khadabadi

CMO & Former NB Reviewer

Reforming Clinical Evaluation of Medical Devices in Europe