CASE STUDY

Urology Portfolio – EU MDR CER Nonconformity Resolution

Client Background

A UK-based medical device sponsor with a portfolio of urology devices received Notified Body (NB) nonconformities against multiple Clinical Evaluation Reports (CERs) under Regulation (EU) 2017/745 (EU MDR).

The Challenge

The CERs required urgent remediation to:

  • Address NB findings
  • Align with Annex XIV requirements
  • Avoid certification delays within strict submission timelines
  • The sponsor needed audit-ready documentation with strengthened clinical justification.

Bioexcel’s Approach

Bioexcel delivered structured, end-to-end NC resolution support:

  • Detailed gap assessment mapped to NB findings
  • Strengthened literature review and traceability matrix
  • Improved equivalence justification
  • Enhanced state-of-the-art alignment
  • Stronger linkage between PMS, Risk Management, and benefit–risk conclusions

Outcome

  • All NB findings addressed within required timelines
  • CERs upgraded to EU MDR-compliant, audit-ready documentation
  • Improved regulatory confidence across the entire urology portfolio

Spinal Implant Systems – EU MDR PMCF Study (Class IIb)

Client Background

Manufacturer of Class IIb spinal implant systems requiring real-world post-market evidence under EU MDR.

The Challenge

To Demonstrate:

  • Continued clinical safety
  • Real-world performance
  • Usability across cervical, thoracic, and lumbar procedures
  • MDR compliance (Rule 8)

Bioexcel’s Strategy

  • Designed retrospective, open-label PMCF study
  • Developed ISO 14155-aligned documentation
  • Created CRFs and coordinated investigators
  • Managed ethics submissions
  • Prepared final PMCF Report for CER integration

Outcome

  • Robust real-world evidence generated
  • Strengthened PMS & PMCF framework
  • Improved EU MDR technical documentation readiness

Clinical Investigation – Digital Thermometer (Class A, India)

Objective

To generate prospective clinical evidence supporting safety and performance under Indian MDR 2017.

Study Highlights

  • Prospective, observational study
  • Accuracy compared to reference thermometer
  • Usability and safety evaluation
  • ISO 14155 & CDSCO aligned

Bioexcel’s Contribution

  • Developed CDSCO-compliant CIP
  • Ethics Committee coordination
  • Oversight under GCP principles
  • Prepared Clinical Investigation Study Report

Outcome

  • No device-related adverse events
  • Confirmed performance within intended use
  • Data suitable for regulatory submissions

Non-Invasive IOP Assessment Device – EU Clinical Investigation

Challenge

Prospective evidence required to confirm safety and comparator-based performance alignment.

Study Design

  • Prospective, comparative, within-subject study
  • Comparator: Standard tonometry
  • Usability and safety evaluation
  • Usability & safety endpoints

Bioexcel’s Role

  • ISO 14155-compliant protocol development
  • Ethics support & investigator coordination
  • GCP-aligned oversight
  • CISR preparation

Regulatory Value

  • No unexpected safety concerns
  • Performance aligned with standard tonometry
  • Evidence strengthened EU MDR readiness

FDA Human Factors Validation – Hemoglobinometer (IVD)

Objective

FDA-aligned protocol review prior to Human Factors Validation Study.

Bioexcel Delivered

  • Regulatory gap analysis against FDA HF guidance
  • Critical task review
  • Simulated-use evaluation assessment
  • Error mitigation analysis

Impact

  • Protocol aligned with FDA expectations
  • Reduced risk of post-study deficiencies
  • Strengthened submission readiness

Diagnostic Catheter – EU MDR Class III Clinical Investigation

Device

Intracardiac electrophysiology diagnostic catheter (Class III).

Challenge

Robust clinical evidence required under EU MDR Annex XV.

Study Overview

  • Prospective, interventional, single-arm study
  • Evaluated insertion, navigation, signal acquisition
  • Safety endpoints included major complications

Bioexcel’s Support

  • MDR-compliant CIP development
  • Ethics approvals
  • GCP oversight
  • CISR preparation

Outcome

  • Successful procedural completion
  • No unexpected device-related SAEs
  • Strong support for CE marking

Guiding Catheter –Interventional Cardiology (Class III)

Objective

Demonstrate safety, usability, and procedural performance.

Key Results

  • No catheter-related complications
  • Positive investigator usability feedback
  • Stable physiological parameters

Regulatory Value

  • Strengthened Article 61 Clinical Evaluation
  • EU MDR Class III conformity support

Hemodialysis Catheters – Long & Short Term (Class III)

Challenge

Demonstrate procedural and functional performance for extracorporeal therapy.

Bioexcel’s Execution

  • MDR Annex XV-aligned CIPs
  • Ethics & CTRI support
  • Safety monitoring framework
  • CISR preparation

Outcome

  • Adequate dialysis flow demonstrated
  • No unexpected safety concerns
  • Strengthened GSPR conformity

PMCF – Cemented Mobile Bearing Total Knee Replacement (Class III Implant)

Objective

15-year PMCF to confirm long-term implant survivorship and safety.

Study Focus

  • Functional scores (KSS, WOMAC)
  • Revision rate monitoring
  • Radiographic stability
  • Long-term risk monitoring

Regulatory Impact

  • Supports Annex XIV Part B compliance
  • Ongoing confirmation of benefit–risk profile
  • Strengthens CER & Technical Documentation

PMCF – Non-Absorbable Synthetic Surgical Sutures (Class IIb)

Objective

Confirm continued safety and performance in real-world surgical use

Study Design

  • Retrospective observational PMCF
  • Focus on wound healing, infection, tissue reaction

Results

  • No unexpected device-related SAEs
  • Complication rates consistent with SoTA
  • Acceptable tissue response

Regulatory Value

  • Supports EU MDR Annex XIV compliance
  • Strengthens Clinical Evaluation & Technical File

CDSCO Import Licence (MD-15) – Indian Market Entry

Client Background

Korean manufacturer entering India through an Authorized Agent & Wholesaler.

The Challenge

  • No documentation aligned to MD-15 checklist
  • Missing device documents
  • No MD-42 wholesale licence
  • Risk of application rejection and delay

Bioexcel’s Intervention

  • Performed MD-15 gap assessment
  • Collected and compiled device-wise documentation
  • Registered Authorized Agent on CDSCO MD Portal
  • Secured MD-42 Wholesale Licence
  • Submitted MD-15 Import Licence application
  • Managed regulatory scrutiny

Outcome

  • Structured regulatory framework established
  • Successful MD-15 submission
  • Strengthened long-term compliance under MDR 2017