Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

I have a rather straightforward question that i would like some input in if i may?

We are currently transitioning from the IVDD to the IVDR with our legacy IVDs. The analytical performance has been demonstrated within the current IVDD technical file as verification plans and reports. The studies themselves are sound, and i do not see the need to repeat them. 

Am i correct in assuming that to utilise these existing plans/reports, we document this approach within the performance evalution plan, complete with justification and data appraisal, and perhaps create an analytical performance report (IVDR) which concludes all the existing data?

Appreciate any input or alternative suggestions

Thanks

Hello Anon,

The simple answer is yes.  There is no need to repeat analytical performance testing if this is already available for the device or has been available under the EU IVDD Directive.  When putting together the Analytical Performance Report (APR) for IVD devices, we quite commonly take all of the existing analytical testing performed (usually already as part of design verification and validation) and summarise this in the APR.  The only reason to repeat testing or conduct new testing is if gaps are identified in the clinical/analytical data under the EU IVDR.  This means conducting a review of the available analytical testing data ensuring it is meeting the requirements under the EU IVDR for performance evaluation (which we find 95% of the time this is the case).  As an additional note, you may also be able to use some of the analytical performance data for your Clinical Performance Report (CPR) depending on how the data was gathered, what samples were used, etc.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-Nov-2022 19:58
From: Anonymous Member
Subject: Analytical Performance Documentation Presentation - IVDR

This message was posted by a user wishing to remain anonymous

Hi All,

I have a rather straightforward question that i would like some input in if i may?

We are currently transitioning from the IVDD to the IVDR with our legacy IVDs. The analytical performance has been demonstrated within the current IVDD technical file as verification plans and reports. The studies themselves are sound, and i do not see the need to repeat them.

Am i correct in assuming that to utilise these existing plans/reports, we document this approach within the performance evalution plan, complete with justification and data appraisal, and perhaps create an analytical performance report (IVDR) which concludes all the existing data?

Appreciate any input or alternative suggestions

Thanks

Hello Anon, 

Like Richard said, it is absolutely appropriate to use IVDD-era analytical performance data for your IVDD submission, assuming there have not been changes to your IVD since the original testing was conducted. If there have been changes (i.e., for an assay that is now run on a different instrument than used in the original AP testing), then either updated testing or a justification may be needed. 

A few things to keep in mind for your APR:
1. The NB will want to see all parameters in GSPR 9.1 a. addressed, even if it is to say "this parameter doesn't apply because (justification)"
2. A literature search for any AP testing published on your IVD can help to support your in-house AP data

Best,

------------------------------
Bethany Chung
Principal, Clinical and Post Market Practice, RQM+
------------------------------

Original Message:
Sent: 16-Nov-2022 00:53
From: Richard Vincins
Subject: Analytical Performance Documentation Presentation - IVDR

Hello Anon,

The simple answer is yes.  There is no need to repeat analytical performance testing if this is already available for the device or has been available under the EU IVDD Directive.  When putting together the Analytical Performance Report (APR) for IVD devices, we quite commonly take all of the existing analytical testing performed (usually already as part of design verification and validation) and summarise this in the APR.  The only reason to repeat testing or conduct new testing is if gaps are identified in the clinical/analytical data under the EU IVDR.  This means conducting a review of the available analytical testing data ensuring it is meeting the requirements under the EU IVDR for performance evaluation (which we find 95% of the time this is the case).  As an additional note, you may also be able to use some of the analytical performance data for your Clinical Performance Report (CPR) depending on how the data was gathered, what samples were used, etc.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Nov-2022 19:58
From: Anonymous Member
Subject: Analytical Performance Documentation Presentation - IVDR

This message was posted by a user wishing to remain anonymous

Hi All,

I have a rather straightforward question that i would like some input in if i may?

We are currently transitioning from the IVDD to the IVDR with our legacy IVDs. The analytical performance has been demonstrated within the current IVDD technical file as verification plans and reports. The studies themselves are sound, and i do not see the need to repeat them.

Am i correct in assuming that to utilise these existing plans/reports, we document this approach within the performance evalution plan, complete with justification and data appraisal, and perhaps create an analytical performance report (IVDR) which concludes all the existing data?

Appreciate any input or alternative suggestions

Thanks