Hi Fady,

I agree that it is not clear as to what exactly “as far as possible” means and what standard it is being compared to. This statement definitely implies that all risks cannot be reduced completely, but should be significantly reduced nonetheless to ensure that the device is safe to use. As long as the manufacturers can verify that the risks are reduced as far as possible within their risk management plan that is a part of their technical documentation, it should be acceptable. Just as others mentioned above, the end goal of any medical device is to be as safe and effective as possible with no risk left unacknowledged and reduced.