Risk analysis is a series of steps that use available data to identify safety-related features, identify hazards, and estimate each hazard of medical devices in both their normal and defective states.
For MDR, IVDR, FDA, or any other regulation, the manufacturer must establish the device’s safety. As a result, risk analysis based on ISO 14971 is required and becomes a requirement. This standard’s requirements apply to the whole life cycle of a medical device.
Risk Analysis shall be carried out in three stages.
The manufacturer must show conformance with the general safety and performance requirements, as well as other requirements such as quality and medical device risk management, according to MDR and IVDR Essential Requirements. EN ISO 14971:2020 is currently harmonised with MDR and IVDR.