ISO 10993-1:2018. Is it Harmonized?
FDA Consultants – CE marking Consultants
Reghelps
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Every medical device comes with risks. The manufacturer must decide which are acceptable risks and which are unacceptable. These are usually expressed in a risk matrix in a risk management file.
Unacceptable risks are the risks that would compromise the health and safety of patients, users or any other persons. Such risks should be definitely reported to the competent authorities so that appropriate measures can be implemented; whereas acceptable risks do not compromise the health of the intended population and are compatible with a high level of protection and safety.
If the residual risk is not judged acceptable using the criteria established in the risk management plan and
further risk control is not practicable, the manufacturer may gather and review data and literature to determine
if the medical benefits of the intended use outweigh the residual risk. If this evidence does not support the
conclusion that the medical benefits outweigh the residual risk, then the risk remains an unacceptable risk.