Clinical investigation - Role of Notified Body (NB)

[HeatherC-S]

Hello

I am working towards CE marking of Class IIb device under the new IVDR, and am wondering what the role of the NB is during the clinical investigation/trial stage as part of the CE marking process.

Obviously our competent authority will be notified and cleared to perform the clinical investigation, as well as updating them of adverse events, results etc.

When the technical file (including the report of the investigation) is submitted to the NB, is this the first time they will be aware of it?

Many thanks

 

[Marcelo]

Just to prevent confusion, you mean performance study, right? Clinical investigation is only applicable to non-IVD devices. The related term that applies to IVDs are performance studies.

The basic NB role is to verify that the conformity assessment route applied by the manufacturer was followed. Performance studies (or clinical investigations in the case of non-IVD devices) are not part of the conformity assessment per se, because they are mainly ways to generate data for the performance evaluation (or clinical evaluation in the case of non-IVD devices.

The performance study or clinical investigation is treated directly with the regulatory authority of the member-state it's being performed.

As to when the NB will be aware of the performance study...well, it depends. If you read the IVDR (for example, search the pdf document for "performance study") you will see that there's no requirement to inform the NB of any performance study, what they have to do is to evaluate the clinical data of your performance evaluation, which may include data from performance studies.

But in practice they may be aware (they will probably ask, for information's sake) about any performance study your device is undergoing.

 

[HeatherC-S]

Hello - Apologies for the confusion. I meant the MDR NOT the IVDR, and therefore is a clinical investigation!

Many thanks for your help.

 

[Mark Meer]

Just to prevent confusion, you mean performance study, right? Clinical investigation is only applicable to non-IVD devices. The related term that applies to IVDs are performance studies. ...

Hi Marcelo,
Curious: do you know why the authors opted to define different terms?

I understand there are differences, but they are largely talking about the same thing, no? It seems to me that creating another (quite different) term just lends itself to more confusion. Why not just prefix the MDR term with "IVD" (i.e. an "IVD Clinical Investigation") to refer to the specific type of investigation?

 

[Marcelo]

Hello - Apologies for the confusion. I meant the MDR NOT the IVDR, and therefore is a clinical investigation!

Many thanks for your help.

Ah ok, the idea is the same.

 

[Marcelo]

Hi Marcelo,
Curious: do you know why the authors opted to define different terms?

I understand there are differences, but they are largely talking about the same thing, no? It seems to me that creating another (quite different) term just lends itself to more confusion. Why not just prefix the MDR term with "IVD" (i.e. an "IVD Clinical Investigation") to refer to the specific type of investigation?

Because, in the case of most IVDs, you do not need to use the device in humans so there's usually no clinical data involved, and thus the focus is to verify the performance of the device only (not what the device directly does to the patient).

You can better see the differences when you look at the different definitions from the MDR and IVDR:

MDR ‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;

IVDR ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;

MDR ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

IVDR ‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;

MDR ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

MDR has a definition of clinical data, IVDR does not.

IVDR ‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;

 

[Marcelo]

Curious: do you know why the authors opted to define different terms?

Just to make it clear - these concepts are not new, they were already in the 1998 IVD Directive and were created way before. So it's not somethings that the authors of the new regulations created.