A trend report is not "prepared"it needs to be planned (for example, you need to contract something like the graphic on
MEDDEV (and yes, MEDDEV 2.12-1 rev 8 did incorporate most of the text of GHTF/SG2/N36R7:2003) for each situation in which trend reporting would apply. Then you need to monitor how much of that situations is happening and, if a statically significant increase happens, you need, between other actions, to inform the regulator.
I think people had a difficult time understand this requirement and I agree that it's not the easy to understand. The way I've been trying to explain in in more light terms is something like these:
- Let's say your device is designed in such a way that some situations that might occur with it, although undesirable, are to be accepted. For example, let's say that a side effect such as going dizzy because of the use of the device is expected in 10 cases of use for each 3 months of use (please note that this is only a generic number used to show the principle). Your risk management noted the problem, and your clinical evaluation "confirmed" it, and then your benefit-risk determination accepted it.
- Then your device is cleared/approved/whatever. This means, between other things, that for the device to be considered safe and effective, the number of occurrence need to be kept under 10 cases of use for each 3 months of use
- Then, you would begin to monitor these occurrences. If, for example, in the first month of use, the device has 4 occurrences of the problem, it's automatically non-compliant, because for the 10 cases in 3 months to be right, the device would need to be under 3 cases per month.
- So, you need to investigate and do something as the manufacturer. Also. because the device is non compliant (remember, it was cleared/approved/etc. for 10 cases in 3 months, not for more than that), you also have to tell the regulator that there's a problem.