within the linked-in "EU Medical Device Regulation (MDR & IVDR) updates" group the following question is discussed:
"The question from industry:
In MEDDEV 2.7.1 rev 4, section 10.3, there are certain devices that may not require clinical data for demonstration of conformity. You mentioned the standards
for electrosurgical devices (EN-60601-1) as an example.
The question is: If a device like an electro-surgery device that fulfills all relevant Harmonized Standards, the Risk Management report does not
reveal any residual clinical risks/hazards, performance and usability can be shown with bench and pre-clinical data - would it be possible to demonstrate conformity, in your opinion,
without the use of clinical data? Or is this clause (10.3) only intended for low-risk devices like a tongue depressor etc.?"
I would like to jump in this discussion with a more clinical and practical point of view. To understand my perspective it might be helpful to know my background.
As a former surgeon and scientist I performed and developed a lot of pre-clinical tests to avoid clinical studies on humans, and as a former head of a clinical research organization (CRO) I learned to focus the question of a study to make it as efficient as possible. I also joined several standardization committees where I learned to understand the spirit and the ideas of the members writing the standard, which is very helpful not to get lost in all the paragraphs. During the 30 years of my career I developed my own view on this topic which is a little different.
Now back to the question if an electrosurgical device needs clinical data to fulfill the requirement of the new MEDDEV 2.7.1 and the new MDR (eventually also FDA and other requirements). First of all I would appreciate to know what kind of device it is? A radio frequency device for coagulation and cutting or one for thermo-ablation, etc. …? In the following I will proceed discussing the question if clinical data is needed, on base of a RF-device.
What are we talking about from a clinical prospective? What would we like to know about the device as a potential patient or user/surgeon using the device? I assume we would like to know on a high level:
1. Can the device cut and control bleeding?
2. What are the potential short and long term hazards of this method/device?
Some of the next questions are in a very high level:
3. What kind of test do I need to demonstrate safety and performance?
a. Bench/Lab test to control electrical safety in general
b. Tests on isolated organs to demonstrate the function in general
c. Test on perfused isolated organs to show function under “blood pressure” as well as distribution of heat
d. If questions were not answered yet by the aforementioned tests can an animal test bring more information? E.g. to get info about long term results and potential intro-operative complications?
e. Are still any questions open to justify a test on a human being and what additional information may we gain from such a study? Is a prospective study design necessary or can we use historic data in a retrospective case series?
f. Can we use study results from other devices as benchmark eventually in combination of the test mentioned before?
From my experience building up a test strategy in that way it is often possible to avoid or at minimum to downsize the effort of animal and clinical studies – furthermore in some cases it is also unethical or impossible to try to answer special questions by a clinical study on humans. E.g. in case of a radio frequency device it might be difficult to measure heat distribution around and in depths of the tissue because I need special electrodes within a widespread region which the surgeon would never touch during surgery? I guess there is no Ethical committee that approves such a study and no patient and surgeon would agree to participate.
To conclude: In some cases clinical studies are not deemed to be necessary if sufficient preclinical data are available to use section 10.3. This needs to be checked carefully for each individual product.
Hope reading these thoughts helps a little bit.
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