The Notified Body Recommendation Group (NBRG) published the draft “Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012” on June 25, 2014. The paper contains interpretations of the content deviations in the EN version of ISO 14971 and provides guidance for manufacturers and Notified Bodies on dealing with those deviations, which have been the cause of great uncertainty and debate over the past two years.
Risk Management Standard EN ISO 14971:2012Minimizing risk by information for safety?
The most-discussed deviation was that of the effectiveness of information for safety. The standard states, “Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users.” The Consensus Paper clearly states that publication of residual risk does not represent a risk mitigation measure. By contrast, information for safety such as a warning in the user manual may be used as a risk mitigation measure.
Verification of effectiveness of risk mitigation measures
All risk-minimizing measures, thus including information for safety, must be examined for correct implementation and effectiveness. This requirement, which was already part of ISO 14971, is not addressed anew in the Consensus Paper – unfortunately, given that many manufacturers are currently lagging behind with particular respect to verification of the effectiveness of safety information. ISO/TR 24971 shows that such assessment may be performed by methods such as a usability engineering process in line with IEC 62366.
Assessment within the quality management (QM) system
Manufacturers must assess the content deviations within their QM system and align processes where necessary. Assessment based solely on the fact that the content deviations are of an informative nature is not sufficient. The NBRG document can serve as the basis for their assessment.
Finding consensus
The interpretations now published correspond to those already practiced by TÜV SÜD since the standard first appeared. However, since the Consensus Paper is still at draft status, changes cannot be ruled out. Further steps are anticipated for the autumn.
