What manufacturers need to understand when conducting a ... · Clinical evaluation Post market surveillance Post market clinical follow up Risk ... PMS report . Summary of safety
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What manufacturers need to understand when conducting a clinical evaluation
Dr Caroline Dore Geraghty
Chief Clinical Evaluator NSAI
www.NSAIinc.com
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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