lifecycle of a medical device / ivd · complaints, literature, user experience . adverse event...

Lifecycle of a Medical Device / IVD

Speaker ― Sally Jennings Chair, TARSC, IVD Australia

Disclaimer

Any comments, issues, actions or decisions described in or with this presentation DO NOT in any way reflect on any device currently or

previously supplied on the market. Examples used DO NOT imply any action or decision on the part of

any sponsor, manufacturer or the TGA.

Clinical Evidence

Design, Develop, Validate Re-Engineer/

Reformulate Approval of Conformity

Product Recall/

Correction Incident/ patient impact

Market and Supply

Advertising Promotion

Complaints, Literature, user

experience Adverse

Event Reporting

Application Audit

Ongoing Reports, TGA audits

Uniform Recall

Procedure

Notification of Change

Application for Inclusion

Manufacturers Evidence

Conformity Assessment

ARTG

ACMD

Code

Lifecycle of a Medical Device / IVD

Example Medical Devices

Class III Medical Device Contains human &/or animal origin material

Class I IVD Medical Device/ Class IIb Medical Device

Self-testing

Pre-Market

Clinical Evidence

Design, Develop, Validate

Approval of Conformity

Conformity Assessment

ACMD

Class III Medical Device Contains human &/or animal origin material

Pre-Market

Clinical Evidence

Approval of Conformity

Advertising Promotion Application

Audit

Application for Inclusion

Manufacturers Evidence

ARTG

Code

Post-Market

Clinical Evidence

Market and Supply

Advertising Promotion

Complaints, Literature, user

experience

Ongoing Reports, TGA audits

ARTG

Code

Lifecycle of a Medical Device / IVD

Clinical Evidence

Incident/ patient impact

Market and Supply Complaints,

Literature, user experience

Adverse Event

Reporting Ongoing Reports, TGA audits

Post-Market

Clinical Evidence

Product Recall/

Correction

Uniform Recall

Procedure

IMPORTANT SAFETY INFORMATION Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj.

WARNING: Do not wear sensor longer than the time indicated in these instructions for use. Doing so may cause adverse skin reactions. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj. Aodjsfewjdsfjdsjfjejdsjfdsfjdskfjdksjfksdjfdsfdsfdsfkdsjfkdskjsdnmdsfn ejwnsdndsknfdsjnfejnfsdjfndsjfdnsjfdnsjfdsnfjdsnfdjsnfdsjnewjndjsfndsjnfdsjnfdjasndsjnjdsnfj.

Post-Market

Clinical Evidence

Design, Develop, Validate Re-Engineer/

Reformulate Approval of Conformity

Notification of Change

Conformity Assessment

ACMD

Clinical Evidence

Clinical Evidence

Design, Develop, Validate Re-Engineer/

Reformulate Approval of Conformity

Product Recall/

Correction Incident/ patient impact

Market and Supply

Advertising Promotion

Complaints, Literature, user

experience Adverse

Event Reporting

Application Audit

Ongoing Reports, TGA audits

Uniform Recall

Procedure

Notification of Change

Application for Inclusion

Manufacturers Evidence

Conformity Assessment

ARTG

ACMD

Code

Disclaimer

Any comments, issues, actions or decisions described in or with this presentation DO NOT in any way reflect on any device currently on the market. Nor do they imply any action or decision on the part of

any sponsor, manufacturer or the TGA.