Impact assessment EN ISO 14971 -- EN ISO 14971: 2019 - Risk Management for Medical Devices

Summary of the Significant changes:

• Fundamental understanding and process for risk management has not changed.
• Introduction of new definitions (benefit, reasonably foreseeable misuse & state of the art).
• Increased attention to benefit-risk analysis, aligning the concept with terminology used in the MDR.
• Additional emphasis on the scope of the ISO 14971-risk management process, i.e. all risks associated with a  medical device, ranging from risks related to electricity, usability, data security etc. 
• The risk management plan has to define the methods and criteria to evaluate acceptability of the overall  residual risk. 
• The requirements to disclose certain residual risks are merged into one requirement, as part of the  “Evaluation of overall residual risk”. 
• More emphasis on the importance of planning of risk management activities, by stating explicitly that  during risk management review, the proper execution of the risk management plan has to be verified. 
• The requirements with regards to production and post-production activities as part of risk management  have been elaborated and restructured. 
• The number of informative annexes to the standard have been decreased and the information moved to  ISO/TR 24971, in order to maintain the focus on the normative requirements. Also because it is easier to  update a Technical Report than a standard. 
• Revise ISO/TR 24971- The Technical Report that provides guidance on the application of ISO 14971.