Why Do We Have To?
This regulation makes many references to risk reduction, including the requirement to reduce risk "as far as possible" within its General Safety and Performance Requirements (GSPR).
What is the EU MDR?
You "plan" your risk acceptability criteria in this document.
What is the risk management plan?
This is the process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
This standard allows manufacturers to define their own policy for establishing risk acceptability, including “reducing risk as far as possible without adversely affecting the benefit-risk ratio.”
What is ISO 14971:2019?
Per MD45, this is “the concept of applying controls cumulatively, regardless of initial risk level, until further risk reduction is not possible, taking into account state of the art and available technologies and ensuring additional controls do not adversely affect the benefit risk ratio.”
What is "risk reduced as far as possible?"
You evaluate the residual risk after this activity.
What is implementation of risk controls?
This procedure requires that “all risks must be reduced as far as possible by applying controls.”
What is MD45, Product Risk Management Procedure?
or
What is MD151971, Risk Management Supporting Procedure?
This document records the conclusion of the overall residual risk evaluation.
What is the risk management report?
The product document(s) that capture the residual risk evaluations for each fault condition.
What is the FMEA?