What manufacturers need to understand when conducting a clinical evaluation
Dr Caroline Dore Geraghty
Chief Clinical Evaluator NSAI
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Clinical evaluation after the MED DEV
Scope
1. Clinical evaluation process
2. Clinical data requirements
3. Equivalency
4. Difference between MED DEV 2.7/1 Rev 4 and MDR
Clinical evaluation process
Chapter VI article 61
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Clinical evaluation
Clinical evaluation
Thorough
Objective
Favourable and
unfavourable
Proportionate to
classification , risk , intended
purpose
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How to conduct
Identify Specify Generate Analyse Clinical
evaluation
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Identify
Safety and performance requirements
State of the art
Common specifications
Clinical data and gaps
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Specify
Intended purpose of the device
Target population
Clinical outcome
parameters
Clinical development
plan
Methods used
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Generate
A: Are you claiming equivalence?
Or
B: Are you generating your own clinical data?
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Equivalence
Annex IV Part A .3
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Equivalence
Technical Biological Clinical
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Chapter VI, Article 61, point 5
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Class III and implantable devices
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Equivalence confirmed
Critical evaluation of scientific literature
Demonstrate access to tech file of equivalent device Sales
Complaints
Vigilance
Recalls
Emerging post market risks
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Clinical data requirements
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Common specification
Identify and align with these
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If no common specification
Generate data
Level of data is proportionate to risk of device
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Class III and certain Class IIb
Option of consulting with expert panel prior to:
Clinical evaluation
Clinical investigation
Opinion shall be documented in CER
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Generate: Clinical development plan
• Animal studies
• First-in-man studies
• Feasibility study
• Pilot studies
• Confirmatory studies
• Post-market clinical follow up
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Implantable and Class III devices
Clinical investigation shall be performed unless:
Device is a modification of device already marketed by same manufacturer
Modified device is equivalent to marketed device
Marketed device conforms to Annex I requirements
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Implantable and Class III devices
Requirement to perform clinical investigation shall not apply:
Device lawfully placed onto market under 90/385/EEC or 93/42/EEC if:
Based on sufficient clinical data
In compliance with common specifications if they exist
Sutures, staples, fillings, braces , crowns, plates, wires, pins, clips , connectors if:
Based on sufficient clinical data
In compliance with common specification if they exist
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Exempted devices
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Annex XVI
Chapter VI article 61 .9 Annex XVI
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No intended medical purpose
Clinical benefit is understood as a requirement to demonstrate performance
Safety data
PMS data
PMCF
Clinical investigations
Clinical investigations shall be performed unless reliance on existing clinical data from analogous devices
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No clinical data presented
Lower risk devices
Adequate justification why non-clinical testing alone is adequate:
Bench testing
Pre-clinical
Chapter VI article 61 point 10
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Post market
Clinical evaluation
Post market surveillance
Post market clinical follow
up Risk
Clinical development
plan
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Post market surveillance system
Chapter VII, Article 83
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Post market data
Summary safety and
clinical performance
Risk
Trend detection
PMS of other devices
CAPA
Clinical evaluation
Instructions for use
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PSUR
Chapter VII article 86
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PSUR
Main PMCF
findings
Conclusion of benefit risk
analysis
Volume of sales, usage frequency
PSUR update
•Class IIb
•Class IIIAt least Annually
•Class IIaAt least every
2 years
•Class I – updated when necessary
PMS report
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Summary of safety and clinical performance
Implantable and Class III devices
Manufacturer creates
NB reviews
Written clearly for the end user +/- patient
Content laid out in Article 32
Publicly available EUDAMED
Referenced on label and IFU where it is publicly available
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MED DEV 2.7/1 revision4
Transition document
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Concepts explained further MED DEV 2.7/1 Rev 4
Frequency of updates of CER
CER team
Stages of clinical evaluation and plan
Importance of PMS
Equivalence
Hierarchy of clinical data
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MDR further expands
Clinical evaluation process
Embeds ISO 14155 into the regulation
Embeds pertinent features of MED DEV 2.7/1 rev4 into the regulation
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New MDR concepts
Common specifications
Expert panel
Periodic safety update reports
Summary of safety reports
Increased scrutiny for high risk devices
Annex XVI products
Equivalence-high risk device contract
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Common specifications
Expert panel
Periodic safety update reports
Summary of safety reports
Increased scrutiny for high-risk devices
Annex XVI products
Equivalence-high risk device contract
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Expert Panel
Who are they?
42
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