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MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation

FoGia

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#1
Hello,

MEDDEV 2.7/1 rev 4 and MDR refer to 'principles of operation' without defining it properly. It's unclear to me what is expected from that description and its level of detail. Do you have references better describing this concept? Or a good source for examples?

Any info would be much appreciated.

Best regards
 
#2
I am not aware of a definition for 'principle of operation' and I believe it would be difficult to define in because of the great variance and complexity between devices.
I would say that 'principle of operation' is one level beneath what you have in the User's manual; it describes how the device achieves its operation from a technological standpoint. Because it is not so well defined you have some tolerance, and if asked you can always provide some more details.

Shimon
 

SKM.Sunil

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#3
I would say that 'principle of operation' is one level beneath what you have in the User's manual; it describes how the device achieves its operation from a technological standpoint. Because it is not so well defined you have some tolerance, and if asked you can always provide some more details.

I am agree with the statement and this is more technical presentation and differ from "mode of action/ mechanism of action".


A Example in my understanding- " A gelatin sponge used for hemostasis"
Principle of operation : The device provides a cascade for platelet aggregation [provide a mechanical barrier to stop bleeding]
Mode of Action: The cell comes in contact with the cascade wall results in platelet activation (break), which provide a base and essential blood clotting factors to initiate clotting.

"A X-Ray"
Principle of operation : electromagnetic radiation and Fluoroscopy . [further can be explained in detail]
Mode of Action: The X-Ray beam pass through the body and a X-ray image is created [further can be explained in detail]
 
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FoGia

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#4
Thank you these are great examples! If I guess this correctly this usually shouldn't be longer than a few sentences?
 
#5
I think of principles of operation as how the device works, and mode of action as how it achieves its medical purpose by working that way.
 
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