Medical devices - Application of risk management to medical devices
Harmonised standard (i.e. it can be used as a presumption of conformity to aspects of the various device directives), is EN ISO 14971:2012
ISO 14971:2007 (EN ISO 14971:2012) specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
In July 2013, the International Standardisation Organisation (ISO) published the guidance document ISO/TR 24971:2013 "Medical devices - Guidance on the application of ISO 14971“. The guidance document includes additional information on some very important aspects of the ISO 14971 standard. Considering these aspects in connection with their risk management processes is worthwhile for manufacturers. The key aspects at a glance:
Where international product safety standards propose specific (and measurable) risk controls to address the particular hazards of a product, the residual risk can be evaluated as acceptable when said risk controls have been implemented and successfully verified, unless there is a clear indication that the risk controls are inadequate.
Differentiation between "information for safety" and "disclosure of residual risk"
The guidance specifies that the ISO 14971 standard differentiates between "information for safety" and "disclosure of residual risk". It clearly points out that "information for safety" is considered to be a risk control measure with a certain effectiveness. The effectiveness of the measure must be verified. This can be carried out by applying the usability engineering process in accordance with IEC 62366. This clarification is very important with respect to the content deviations identified in the European version of the standard EN ISO 14971:2012.
Acceptability of overall residual risk
After all risks have been mitigated, the manufacturers must evaluate the overall residual risk. The guidance document establishes the criteria for such an evaluation and also specifies that an evaluation of the overall residual risk may not, or may not solely, be based on the fact that all individual risks are acceptable.
Policy for determining the criteria for risk acceptability
The guidance document explains how to fulfil the requirement of the ISO 14971 standard that top management has to "define and document the policy for determining criteria for risk acceptability".
Production and post-production feedback loop
The guidance document adds some information to this process step of the ISO 14971 standard.
(*) This standard was last reviewed in 2010 (ISO standards are reviewed every five years).