Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices

What is a valid ISO 13485 QMS certificate accepted by the TGA?

International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The TGA accepts ISO 13485 certificates issued by Notified Bodies or an International Accreditation Forum (IAF) certified conformity assessment body.

Refer to the Table provided below for a summary of TGA accepted manufacturer’s evidence for IVD medical devices.

Device Classification	AU (TGA)	EU	Canada	US (FDA)	ISO 13485:2016
Class 1 IVD	N/A	N/A	N/A	N/A	N/A
Class 2 IVD	TGA CA Schedule 3 Part 1 (excluding clause 1.6); or Part 4.	CA issued under EU IVDD 98/79/EC Annex IV.3; or Annex VII. OR CA certificate issued under EU IVDR 2017/746 Annex IX Chapter I; or Annex XI (except Section 5).	ISO 13485 issued by CMDCAS Recognised Registrar; or MDSAP Certificate.	MDSAP Certificate.	Issued by a Notified Body designated under the IVDD 98/79/EC. OR Issued by an accredited body that is a signatory to the IAF MLA. Only for IVD applications submitted before 26 May 2023.
Class 3 IVD	TGA CA Schedule 3 Part 1 (excluding clause 1.6); or Part 4.	CA issued under EU IVDD 98/79/EC Annex IV.3; or Annex VII. OR CA certificate issued under EU IVDR 2017/746 Annex IX Chapter I; or Annex XI (except Section 5).	ISO 13485 issued by CMDCAS Recognised Registrar; or MDSAP Certificate.	MDSAP Certificate or PMA.	Issued by a Notified Body designated under the IVDD 98/79/EC. OR Issued by an accredited body that is a signatory to the IAF MLA. Only for IVD applications submitted before 26 May 2023.
Class 4 IVD	TGA CA Schedule 3 Part 1 (excluding clause 1.6); or Part 4.	CA certificate issued under EU IVDD 98/79/EC Annex IV.3; or Annex VII. OR CA certificate issued under EU IVDR 2017/746 Annex IX Chapter I; or Annex XI (except Section 5).	N/A	N/A	N/A

Abbreviations: CA = Conformity Assessment, CMDCAS = Canadian Medical Device Conformity Assessment System, MLA IAF = Multilateral Recognition Arrangement of the International Accreditation Forum, IVD = In Vitro Diagnostics, IVDD = In Vitro Diagnostic Directive, IVDR = In Vitro Diagnostic Regulations, MDSAP = Medical Device Single Audit Program, PMA = Premarket Approval

 

What is changing?

The COVID-19 pandemic had a significant impact on the IVD industry which was burdened with the increased demand for diagnostic devices to support the community and health care industry. As such, the complete implementation of IVDR (EU) 2017/746 was delayed and the transitional arrangements extended under Regulation (EU) 2022/112. This allowed IVD device manufacturers more time to comply with the updated Regulations.

As a result the TGA have revised the transitional timelines set for accepting ISO 13485 certificates issued by a Notified Body under the Directive 98/79/EC or IAF accredited conformity assessment bodies.

What are the new timelines?

New applications for inclusion of Class 2 and Class 3 IVD medical devices on the ARTG may continue to be supported with a valid ISO 13485 certificate until 26 May 2023.

Where manufacturers have lawfully placed their Class 2 IVD medical device on the market before 26 May 2022 and hold an EU Declaration of Conformity (DOC) under IVD Directive 98/79/EC they may apply for inclusion on the ARTG until 26 May 2027.

Where manufacturers have lawfully placed their Class 3 IVD medical device on the market before 26 May 2022 and hold an EU Declaration of Conformity (DOC) under IVD Directive 98/79/EC they may apply for inclusion on the ARTG until 26 May 2026.

Conclusion

The revised reforms have been implemented to ensure that high risk Class 2 and Class 3 IVD medical devices continue to be supplied and it equally provides the industry time to comply with the new requirements following the fallout from the COVID-19 pandemic.

It is noted that all medical device and IVD medical device manufacturers need to ensure that they maintain up-to-date evidence of conformity.

If this change applies to your device or if you have any medical device regulatory concerns, contact KD&A, we can support your organisation with your medical device and/or IVD compliance requirements.