How do others interpret 'likely' in the MDR regulation and guidance? For reference the MDR language is: "[The event is reportable if] ... your device has malfunctioned and the device or a similar device marketed by you would be likely to cause or contribute to a death or serious injury if the malfunction recurred."
Do you treat likely as 'could' or do you apply some sort of numerical criteria (50%, 10%, 1%???). Specifically in the case of delay during surgery, as delay while under general anesthesia increases the risk of an adverse event, so its hard to determine how to interpret 'likely'. Interestingly in the MDR guidance document the 'hypothetical' question posed in 4.1.1 indicates some companies default to reporting all delays but the FDA response clearly says that is not necessary. Would welcome some perspectives from others on this.
We're considering providing a guidance that if the delay is beyond the typical variation seen in the procedure (say a 10-minute delay for a procedure that typically takes 10-20 minutes) then consider it reportable. The thinking is that delays below 10 minutes are within the typical variation and thus a malfunction causing a 10-minute delay in completion of the procedure (with no adverse effects) are not likely to be a source of injury. Yes, all these numbers are made up for discussion purposes so don't focus on the specific durations noted here.
Do you treat likely as 'could' or do you apply some sort of numerical criteria (50%, 10%, 1%???). Specifically in the case of delay during surgery, as delay while under general anesthesia increases the risk of an adverse event, so its hard to determine how to interpret 'likely'. Interestingly in the MDR guidance document the 'hypothetical' question posed in 4.1.1 indicates some companies default to reporting all delays but the FDA response clearly says that is not necessary. Would welcome some perspectives from others on this.
We're considering providing a guidance that if the delay is beyond the typical variation seen in the procedure (say a 10-minute delay for a procedure that typically takes 10-20 minutes) then consider it reportable. The thinking is that delays below 10 minutes are within the typical variation and thus a malfunction causing a 10-minute delay in completion of the procedure (with no adverse effects) are not likely to be a source of injury. Yes, all these numbers are made up for discussion purposes so don't focus on the specific durations noted here.
