Dear Pascale,
The comments that I am making here are entirely made from a European regulatory perspective. There may be differences with US FDA language.
Let me start with a direct comment to the three terms in your question:
- Clinical study: this term is not used at all in the (EU) IVD world. Or should not be used at all. If it is used in colloquial language, it probably means "Clinical Performance Study", but it is not the correct regulatory term.
The European IVD industry has always argued that the IVD are not subject to Clinical Studies but to Performance Evaluations, because the term "Clinical Studies" is associated with a bunch of regulatory requirements (burdensome applications, ethical issues, ...). The idea was supported by the IVD Directive. The term "clinical" occurs twice (2 times) in the entire Directive. In the Regulation, "clinical" occurs 206 times! This illustrates one of the major changes in the Regulation: heavily increased attention to the clinical aspects of an IVD.
- Clinical evaluation: not used either. This combination of words is absent in the IVD Regulation. The correct term is Clinical Performance Evaluation. Clinical performance must be evaluated and can be based on Clinical Performance Studies, scientific peer-reviewed literature and/or published experience gained by routine diagnostic testing. In other words, Clinical Performance Studies are one of the input into Clinical Performance Evaluation.
- Clinic investigation: same story. This combination of word does not occur in the IVD Regulation. Actually, it does. Once. In the pre-amble while referring to clinical investigations for medical devices. If used in the IVD context, it probably refers to a Clinical Performance Study.
Clinical Performance is one component of Performance Evaluation, which is performed to collect and discuss Clinical Evidence. The other components are Scientific Validity and Analytical Performance. The three components each have their specific role in Performance Evaluation and specific contribution to Clinical Evidence.
Although the IVD Regulation has introduced concepts and requirements that bring the Clinical Performance Studies closer to clinical investigations for medical devices, there are still significant differences. This is now also reflected in the standards. IVD were never in the scope of ISO14155, but the IVD industry now has its equivalent: ISO20916. It is not on the list of harmonized standards, yet, but undoubtedly will be and it is already highly recommended to implement it. It is well aligned with the requirements of the Regulation itself.
I hope this helps. I always encourage everyone to use the terms as they are (clearly) defined in the Regulation. Simply to avoid confusion. They are not always the ones you would intuitively use, but they have the advantage of being well defined.
Feel free to reach out to me, if you need more information.
Best regards,
Dirk
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Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.comhttps://www.qarad.com------------------------------
Original Message:
Sent: 11-Dec-2021 02:56
From: Richard Vincins
Subject: European régulation for IVD MD (2017/746) and clinical investigation / evaluation
Hello Pascale,
The conduct of a clinical investigation is general as described in ISO 14155 for subject protection, informed consent, record keeping, etc. However, the similarity between Clinical Evaluation - medical device - and Performance Evaluation - IVD medical device - are not too much. Performance evaluation under IVDs look at scientific validity, analytical performance, and clinical performance. Clinical evaluation under medical devices look at safety, performance, and clinical benefit versus risk. There are nuisances between the two but there is definitely a different approach. This is why there are two regulations and not just one.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 10-Dec-2021 09:24
From: PASCALE BLANGARIN
Subject: European régulation for IVD MD (2017/746) and clinical investigation / evaluation
Dear all,
I have some difficulties to understand what are the nuances between clinical investigation, clinical study, clinical evaluation and do all these concepts apply to in vitro diagnostic medical devices?
Thank you very much for your clarification on this subject
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PASCALE
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