MDR defines Risk as the combination of the probability of occurrence of harm and the severity of that harm. A Risk Benefit Analysis helps to balance the benefit with the inherent Risk. As per article 10 of MDR, Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
Risk management is a iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. Following are the requirements of risk Analysis for each Medical Device.
A risk management plan
Identification and analysis of possible hazards associated with each device
Estimation of risk associated with the intended use and misuse of the device
Risk mitigation (reduction or elimination of risk) eliminate or control the risks
Assessment of production and post-market Surveillance information on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability
necessary amend Risk control measures like safety by design, alarms, safety information and necessary training for the assessment of PMS.
EU Medical Devices Regulation (MDR 2017/745) April 5, 2017.
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices.
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