MEDDEV 2.12.1 rev 6 Trending of Non-Reportable Events question

M

mogluk

#1
we had our aunnual Iso surveillance audit and we received a finding on trending of non-reportable events that may require reporting.

I am curious how others conform to trending of non-reportable events?

I trend the complaints but we have no threshhold of non-reportable events to determine when we actually report to NB......at first my auditor and I went around the room debating this issue but I still am having a hard time in how we would determine a threshold without just picking a number out of the air?
 
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Sam Lazzara

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#2
Re: meddev 2.12.1 rev 6 trending question

Per MEDDEV 2.12-1 (section 5.1.4), events or incidents that are excluded from reporting per the above analysis are still subject to reporting if a significant increase or trend of events or incidents is identified.

It is the manufacturer's decision to determine the trending threshold for reporting these normally non-reportable events.

I don't think it is reasonable/practical to update the trending analysis on a complaint-by-complaint basis. I suggest creating a requirement to perform a trending analysis once per quarter (by product by complaint type), and determining whether you cross your defined threshold. My recommendation is for the quarterly trend analysis to show the trending for the prior 6 months.

Here is an example of a threshold requirement.

Significant Trend Trigger Level: PPR increases 3 months in a row (month over month) and the month over month PPR increase averages greater than XX% for the 3 months.

You choose the XX%. Your Notified Body could ask how you determined it but it is your decision. Since these are presumably low risk events, it probably is not prudent to be aggressive with your trigger level definition.

Confirmed Product Problems (CPP): The number of complaints received during a specified date range for which a product problem was confirmed or could not be ruled out.

Applicable Product Denominator (APD): The number of devices applicable to a particular type of Product Complaint that were distributed for clinical use during a specified date range.

Product Problem Rate (PPR, %): (CPP/APD) x 100
 
M

mogluk

#5
thank you for all your comments I am getting a better understanding of the trending requirement
 
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