medical device regulatory approval
DESCRIPTION
TRANSCRIPT
Medical Devices - Regulatory
Approval Submissions
J. M. Brinch
Which are our markets and who are the regulators?
FDA
TPDTUV
MHLW
TGA
SFDA
More than 80 countries worldwide
Regulatory Requirements
The device and its intended purpose must be
defined
The device’s safety and effectiveness must
be assured
The benefits of the device must outweigh the
risks associated with its use
Reference
Essential Principles of Safety & Performance of
Medical Devices
Regulatory ControlsRegulatory Audit
Quality Management System - Risk Management
Premarket
Classification – Conformity Assessment
Postmarket Surveillance
Conformity Assessment (continued)
Registration
Listing
Essential Principles
Standards
Device Specification
Design Control
Design verification and validation
Clinical Evidence
STED
Declaration of conformity
Adverse Event Reporting
Complaint Management
Maintenance and Service
Corrective and Preventive Actions
Postmarket clinical follow up
Summary Technical Documentation
Regulatory Controls
Devices are typically assigned to four risk classes (EU => I,
IIa, IIb, III + AIMD)L
evel
of
Contr
ol
Device Risk Class
Regulatory Management
at Cochlear
• Cochlear has quality management system in
place and use a compliant design control process
(DCP/PIP) and manufacturing processes
• Cochlear Regulatory Affairs use an assessment
procedure to determine what regulatory action is
required for a new design or design change
(including manufacturing process)
Illustration of our Process for product to market
Reg Strat
Reg Plan
Reg Sub & app.
Doc Prep
Clin Strat
Trial Plan
Trial & report
Trial Doc
REGULATORY APPROVAL
MANAGEMENT PROCESS
E12024AG
Summary Technical Documentation - generic Device Description and Product Specification, Including Variants and Accessories
Device Description
Product Specification
Reference to similar and previous generations of the device
Labelling
Design and Manufacturing Information
Device Design
Manufacturing Processes
Design and Manufacturing Sites
Essential Principles (EP) Checklist
Risk Analysis and Control Summary
Product Verification and Validation
General – Electrical/Mechanical standards compliance
Biocompatibility
Medicinal Substances
Biological Safety
Sterilisation
Software Verification and Validation
Animal Studies
Clinical Evidence
Submission Package
Declaration of Conformity
• An attestation that each device that is subject to the declaration:
complies with the applicable Essential Principles for Safety and Performance,
has been classified according to the classification rules, and
all the applicable conformity assessment elements has met
• Information sufficient to identify the device/s to which the Declaration of Conformity
applies.
• The Global Medical Device Nomenclature (GMDN) code and term for the device .
• The risk class allocated to the device/s after following the guidance found in Principles
of Medical Devices Classification .
• Which of the conformity assessment elements described in Section 5 have been
applied.
• The date from which the Declaration of Conformity is valid.
• The name and address of the device manufacturer.
• The name, position and signature of the responsible person who has been authorised
to complete the Declaration of Conformity upon the manufacturer’s behalf.
•
Submission Package
Generation of the STED
QUALITY SYSTEM DESIGN PROCESS GUIDELINE
PROCESS OUTPUTS
TECHNICAL
DOCUMENTATION (Controlled
Documents e.g. Under a QMS)
SUMMARY TECHNICAL
DOCUMENTATION (STED)
Upon request, prepare
STED for Class A & B
devices & make available
for review by RA/CAB
For Class C & D devices
prepare and submit
STED to RA / CAB for
review
FIGURE 1: PREMARKET USE OF THE STED
Device description and product
specification, including variants and
accessories
General description and list of
specified features
LabellingSet of labels and list of language
variants
Complete design and manufacturing
information
Summary of the technical
documentation concerning design
and manufacturing
Relevant Essential Principles and
proof of conformity E.P. Checklist
Device risk management file Risk analysis and control summary
Clinical evidence Clinical evaluation report
Complete product verification and
validation documentation
Summary of verification and
validation studies
Documentation subset
Documentation subset
Documentation subset
E.P. Checklist
Documentation subset
Documentation subset
Documentation subset
Summary Technical Documentation - STED
TECHNICAL
DOCUMENTATION (Controlled
Documents e.g. Under a QMS)
SUMMARY TECHNICAL
DOCUMENTATION (STED)
Upon request, prepare
STED for Class A & B
devices & make available
for review by RA/CAB
For Class C & D devices
prepare and submit
STED to RA / CAB for
review
FIGURE 1: PREMARKET USE OF THE STED
Device description and product
specification, including variants and
accessories
General description and list of
specified features
LabellingSet of labels and list of language
variants
Complete design and manufacturing
information
Summary of the technical
documentation concerning design
and manufacturing
Relevant Essential Principles and
proof of conformity E.P. Checklist
Device risk management file Risk analysis and control summary
Clinical evidence Clinical evaluation report
Complete product verification and
validation documentation
Summary of verification and
validation studies
Documentation subset
Documentation subset
Documentation subset
E.P. Checklist
Documentation subset
Documentation subset
Documentation subset
STED
Device description
• a general description of the device
• the functional purpose
• comparisons to other devices
• the intended patient population(s)
• contraindications
• an explanation of any novel features;
• the accessories
STED
Device description
• materials and their physical properties
• the functional characteristics and
technical performance specifications
• chemical, physical, electrical,
mechanical, biological, software,
sterility, stability, storage and transport,
and packaging
STED
Labelling
• labels on the device and its packaging;
• instructions for use;
• other literature or training materials;
• instructions for installation and maintenance ;
• Any information and instructions given to the
patient, including instructions for any procedure
the patient is expected to perform.
STED
Manufacturing information
Summary of documentation related to the
manufacturing processes, including quality
assurance measures, which is appropriate to the
complexity and risk class of the device.
Emphasis on “critical” process eg those requiring
validation.
STED
Essential Principles and evidence
of conformity
Presented as a table
Essential Principle
Applicability
Standard(s) used
Document showing evidence
STED N31408AG
STED
Risk assessment
Summary of or the complete
results of the risk assessment.
This assessment should be
based upon international or
other recognized standards,
and be appropriate to the
complexity and risk class of
the device.
Mitigation of risk should also
be shown
ISO14971
STED
Summary documents of pre-clinical
design verification and validation
summaries or reports of
tests and evaluations
based on other standards,
manufacturer methods
and tests, or alternative
ways of demonstrating
compliance
• engineering tests
• laboratory tests
• biocompatibility tests
• animal tests
• simulated use
• software validation
STEDSummary documents of pre-clinical
design verification and validation
Clinical Evidence
Evidence that all the
device is clinically safe
and effective and meets
the clinical claims
• a systematic review of
existing bibliography
• clinical experience with
the same or similar
devices
• by clinical investigation
Decleration of Conformity
Documentation
•The regulators are key
customers for our
documentation
•Documentation quality is
essential
Documentation Guidance
• Clear
• Logical
• Factual
• Selfcontained
Working with the
regulators is a normal way
of life at Cochlear