The process described will help medical device manufacturers:
Identify the hazards associated with the medical device
Estimate and evaluate the associated risks
Control these risks
Monitor the effectiveness of the controls
The standard’s requirements apply to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as those related to biocompatibility, data and systems security, electricity, moving parts, radiation and usability. It can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
NOTE 1: This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure or business risk management.
NOTE 2: The standard requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
NOTE 3: Risk management can be an integral part of a quality management system. However, this standard does not require the manufacturer to have a quality management system in place.
What’s changed since the last update?
This is a revision of ISO 14971:2007 (BS EN ISO 14971:2012). It improves the information on the implementation of the risk management process. In particular:
More attention is given to the expected benefits of using the medical device. The term benefit-risk analysis has been aligned with terminology used in some regulations
The method for evaluating the overall residual risk and the acceptance criteria are to be defined in the risk management plan
The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.