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Old 11th July 2018, 12:42 PM
Marcelo Antunes's Avatar
Marcelo Antunes

Total Posts: 3,375
Re: Clinical investigation - Role of Notified Body (NB)

In Reply to Parent Post by Mark Meer View Post

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;
Thanks to Marcelo Antunes for your informative Post and/or Attachment!

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