This session will examine some of the hot topic in this areas including a presentation from TGA covering some of the challenges they are seeing locally as well as an industry perspective on global hot topics and trends in device vigilance

1. Device Vigilance
Local Challenges & Global Trends
Pam Carter
Director, Device Vigilance and Monitoring Section
Medical Devices Branch, TGA
ARCS Conference 2018
21 August 2018

2. Topics
Local challenges
• Medical Device reforms
– MMDR
– Inquiries and the results
• Relationship between sponsor and
manufacturer
• Education and training
• Reporting of AEs
• Relationship with health facilities and
professionals
Global hot topics and trends
• Women’s health
• Post market surveillance
– PSUR/Annual reporting
– Life cycle responsibilities
– Post market surveillance studies
• Reporting AEs
– Electronic
– Web forms
– Databases
– Harmonisation
– Communication between regulators

3. Local Challenges

4. Expert Panel Review (MMDR)
• Two reports released during 2015
– Medicines and Devices
– Complementary medicines and Advertising
• Review included discussion papers, submissions and interviews, followed
by stakeholder workshops and other meetings
• Department considered feedback and advised Minister, who took
preferred position to Cabinet
• Government intent released in May 2016 budget - full response released
on 15 September 2016
– Government accepted 56 of the 58 Recommendations

5. MMDR medical device projects
• Key projects
• Designation of conformity assessment bodies in Australia
• Expedited review process for certain ‘novel’ devices
• Use of approvals from comparable overseas regulators
• Harmonisation with the European Union
• Strengthening of post market monitoring

6. European Harmonisation
MMDR recommendation:
• Align with new European regulatory framework where possible
• Clear rationale for Australian specific requirements
EU MDR and IVD Regulations came into force on 26 May 2017
Key changes include:
• Definitions
• Classification
• Conformity assessment procedures
• Essential Principles and General Safety &
Performance Requirements
• EU regulations also capture in-house IVDs
• Implant cards and patient leaflets

7. Medical Devices reforms
Patient Implant Cards and Device Information Leaflets
• From 1 December 2018, patient implant cards will begin to be supplied with new
implantable medical devices (starting with urogyanecological mesh)
• All permanently implantable devices are affected:
– Phased approach to be fully implemented by 1 December 2021
• Addresses an information gap
• Exempted products:
– simple implants (dental fillings, dental braces, tooth crowns, endosseous dental
implants, screws, etc.)

8. Medical Devices reforms
Patient Implant Cards and Device Information Leaflets
Must include the following information about the device:
Cards
– Name
– Model
– Batch code, lot number or serial number
– Unique device identifier (if any)
– Manufacturers name, address and website
Leaflets
– information identifying the device, or the kind of
device
– the intended purpose
– information explaining how to use the device safely
– other information that the manufacturer considers
would be useful for patients

9. Post market monitoring
• Better integration and timely analysis of
available datasets
• Electronic reporting of adverse events
• Enhanced information-sharing with overseas
regulators
• Deferred: Implementation of registries for all
high risk implantable device

10. Reforms vs Recommendations from Inquiries
• Reforms
– Quicker access to medical device technology through:
 Multiple pathways to inclusion
 Use of overseas approvals
• Inquiries
– Hips, breast implants, urogynaecological mesh, private health insurance, cosmetic industry, health
technology
 More oversight of medical devices pre and post market
 More information for patients and health professionals
 Medical Device Registries

11. Relationships
• Relationship between sponsor and manufacturer
– Signed agreements
– Flow of information
– Understanding the Australian regulatory system
• Relationship with health facilities and professionals
– inSite
– Who is reporting an adverse event and to whom
– Limitations of the Therapeutic Goods Act
– Expectations on sponsors and manufacturers
 Replacement of devices
 Reporting

12. Education and Training
• Sponsors:
– Staying included
– Sponsor training day
– SME
– consultation
• Health Professionals
– inSite
– Web statements
– MDSU
– Consultation

13. Reporting of AEs
Still need to work on:
• No ARTG number
• Insufficient information
• Statistics
• Timely response to investigation
Getting better
• Submitting final reports
• Statistics
• Using web portal

14. Global hot topics and trends

15. Women’s health
• Mesh
• Breast implants
• Contraceptive devices
• Morcellators
• Dermal fillers

16. Post market surveillance
• PSUR/Annual reporting
– Align with European guidance
• Life cycle responsibilities
– Post market surveillance studies
– MDSAP
– Post market reviews
Clinical
Evidence
Report
Risk
assessment
Risk
mitigations
Post-market
vigilance

17. Reporting Adverse Events
• Electronic reporting
• Web forms
• Databases
• Harmonisation
– Adverse event terminology codes
 Annex A: Problem terms and codes
 Annex B: Type of Investigation terms and codes
 Annex C: Investigation Findings terms and codes
 Annex D: Investigation Conclusion terms and codes
 To come: Annex E - Clinical Signs, Symptoms and Conditions,
and Annex F – Health Impacts
• Communication between regulators