Annex ZA of ISO 14971:2012 - Deviation 7 - Incorrect Interpretation

jdoran

Starting to get Involved
#11
Hi Marcelo,

Deviation #7 is related to the third option of risk control of ISO 14971, information for safety. It related directly to the third option of risk control in the directive: inform users of the residual risks due to any shortcomings of the protection measures adopted.
I don't think that ER 2 only specifies 3 options for risk protection measures. There are three -dashed statements, but the second statement says other appropriate protection measures(plural). A literal reading of this ER does not suggest that any options for protection measures are off the table, including of course warnings. For example, it does not preclude operator training as a protection measure, which is an important protection measure for certain devices such as MRI and X-ray machines. I do concur that the effectiveness of such protection measures need to be validated just like inherent safety by design measures need to be verified.

The wording of the ERs is of course open to interpretation, but I would hope to achieve a consensus across the industry about their intention so as to level the playing field and ease the burden on medical device manufacturers. So far, many notified bodies seem to be in agreement with deviation #7, and I still feel that this is a gross misinterpretation of ER 2. I would really like to hear more (anonymised) notified body interpretations on #7 if anybody else has anecdotes to share!

JD
 
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