Regulatory Open Forum

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!

Hi Anon,

could you give some examples for the tests? Usually I would assume that "baseline safety parameters" can be measured using standard CE-marked IVDs. Or are these specific parameters that are exclusively used in the context of a clinical trial?

Best regards, Christoph

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!

Christoph,

These would be baseline safety labs (eg, CBC, LFTs, renal function...).

Thank you!

Hi Anon,

could you give some examples for the tests? Usually I would assume that "baseline safety parameters" can be measured using standard CE-marked IVDs. Or are these specific parameters that are exclusively used in the context of a clinical trial?

Best regards, Christoph

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!

You may be able to answer this question yourself. First step is to detemine if the intended purpose describes a medical purpose. Is the test intended to diagnose, predict, or prognose a disease or disability, or is it investigating a physiological or pathological process or state? If so, it is a medical device and you can go the next step. If not, you can stop and the product should not be considered an IVD under the IVDR. The second step is to determine if it would be considered an IVD. Is it intended to examine specimens taken from the human body to provide information about a physiological or pathological process or state, congenital impairments, predispostion to medical condition or disease, determination of the safety and compatibility with potential recipients, prediction of treatment responses, or for monitoring therapeutic measures? If so, it appears to be an IVD under the IVDR, if not, it will most likely be a medical device. 

Reach out if you need help with this.

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!

Ronald, thank you so much.  Very helpful!

You may be able to answer this question yourself. First step is to detemine if the intended purpose describes a medical purpose. Is the test intended to diagnose, predict, or prognose a disease or disability, or is it investigating a physiological or pathological process or state? If so, it is a medical device and you can go the next step. If not, you can stop and the product should not be considered an IVD under the IVDR. The second step is to determine if it would be considered an IVD. Is it intended to examine specimens taken from the human body to provide information about a physiological or pathological process or state, congenital impairments, predispostion to medical condition or disease, determination of the safety and compatibility with potential recipients, prediction of treatment responses, or for monitoring therapeutic measures? If so, it appears to be an IVD under the IVDR, if not, it will most likely be a medical device. 

Reach out if you need help with this.

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!

Are local laboratory tests used for patient inclusion/exclusion criteria (eg, baseline safety parameters, these are not biomarkers used for patient selection), considered to have a 'medical purpose' under the IVDR regulation and therefore subject to the IVDR requirements?

Thank you!