This document discusses regulatory approval requirements for medical devices. It notes that medical devices must be approved by regulators in over 80 countries worldwide. Key requirements include defining the device and intended use, ensuring safety and effectiveness, and that benefits outweigh risks. Regulatory controls include audits, quality management systems, premarket reviews, postmarket surveillance, and assigning devices to one of four risk classes. The document outlines Cochlear's regulatory approval process, including developing a regulatory strategy and plan, clinical evidence, and generating a Summary Technical Documentation for submission to regulators. It emphasizes that high quality documentation is essential for regulatory approval.

1. Medical Devices - Regulatory
Approval Submissions
J. M. Brinch

2. Which are our markets and who are the regulators?
FDA
TPD
TUV
MHLW
TGA
SFDA
More than 80 countries worldwide

3. 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

4. Regulatory Controls
Regulatory 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

5. Regulatory Controls
Devices are typically assigned to four risk classes (EU => I,
IIa, IIb, III + AIMD)
LevelofControl
Device Risk Class

6. 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)

7. 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

8. REGULATORY APPROVAL
MANAGEMENT PROCESS
E12024AG

9. 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

10. 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

11. Generation of the STED
QUALITY SYSTEM DESIGN PROCESS GUIDELINE
PROCESS OUTPUTS
TECHNICAL
DOCUMENTATION (Controlled
Documents e.g. Under a QMS)
de
F
FIGURE 1:
Device description and product
specification, including variants and
accessories
Labelling
Complete design and manufacturing
information
Relevant Essential Principles and
proof of conformity
Device risk management file
Clinical evidence
Complete product verification and
validation documentation

12. 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
Labelling
Set 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

13. 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

14. 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

15. 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.

16. 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.

17. STED
Essential Principles and evidence
of conformity
Presented as a table
 Essential Principle
 Applicability
 Standard(s) used
 Document showing evidence

18. STED N31408AG

19. The Use of Standards
N30344AG – Cochlear Standards

20. 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

21. 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

22. STED
Summary 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

23. Decleration of Conformity

24. Documentation
•The regulators are key
customers for our
documentation
•Documentation quality is
essential

25. Documentation Guidance
• Clear
• Logical
• Factual
• Selfcontained

26. Working with the
regulators is a normal way
of life at Cochlear