Preparing the IFU in compliance with MDR 745, Chapter III

V

Vicky Santos

Registered
#1
#1
Hi Marc,

Our company is initially applying for CE marking and currently preparing the IFU in compliance with MDR 745, Chapter III- Requirements regarding Information supplied, Section 23.4. Our medical device is a Class IIb, Implant (Intraocular lens).
I have question on item c) where applicable, a specification of clinical benefits to be expected and e) performance characteristics of the device. How to demonstrate these in IFU? Can you pls. provide me an example for more understanding? Thank you!
 
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F

François

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#2
#2
In my understandings, it shall be based on your clinical evaluation report and your risk benefits assessment.

c) clinical benefits: If a patient uses your lenses, what will be the positive impact on his/her health.
e) performances characteristics of the device shall be equivalent to your clinical claims. Maybe, you can add some more technical performances that are useful for users to make a decision between your products and another one.
 
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