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Trend Reporting under the EU MDR

#1
I am drafting a trend reporting procedure and was wondering if anyone has any information on establishing trigger levels for trend reporting under Article 88 of the EU MDR? An example will be very helpful
 
#4
Hi, Marcelo.
Following the question of thosan, I would like to inquire further.
Trend reporting also exists in the existing MEDDEV 2.12-1(Rev8), and I think it's next.

- A general incident that is not serious enough to meet the requirement to submit an incident report.
The company is monitoring the trend of the incident itself,
Report to the National Competent Authority, using the form in Annex 7 of MEDDEV 2.12-1 rev 8, if an increase in the frequency of the incident is
found.

In other words, I think it is not necessary to prepare a trend report submitted to the National Competent Authority if the trend of incidents that can be reported during the PMS activities is not identified.(There is no trend report, so there is no meaning of trend reporting.)
Is that what I understand?
Of course, trend analysis will have to be continued by the manufacturer. However, I do not believe that submission of such an analysis to the National Competent Authority in the name of a trend report is required by the MDR.

The MDR also requires the PSUR to include trend reporting as a result of PMS activities.
Should the manufacturer summarize in PSUR the number of trend reporting during the PMS period, the content of the report, and corrective action for the trend?
Please advise.
 

Marcelo

Inactive Registered Visitor
#5
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.
 
#6
Thanks, Marcelo.
I think what I understand is right.

"The manufacturer has established the number of occurrences of an incident that can be accepted according to the benefit-risk analysis, but only if this frequency is exceeded, the manufacturer should write a trend report and submit it to he National Competent Authority." This is "Trend reporting".
In other words, it is common practice for manufacturers to monitor trends in accidents regularly, and it is a requirement of MDR to write and submit trend reports only if they exceed pre-set criteria during the monitoring process.
 
#7
Hello Marcelo (and all),

Per the EU MDR (Article 88), Trend Reporting is required for "any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits."

MEDDEV 2.12-1/rev 8 required trending on a significant increase in events not normally considered incidents per 5.1.3 (e.g., expected side effects or deficiencies identified prior to use). My U.S. company has been granted a CE Mark under the MDD, but we'll have to comply with sections 83-89 of the MDR after May 26, 2020.


Will MDR section 88 on Trend Reporting supersede the MEDDEV 2.12-1 trend-reporting requirements, or will we have to do both?
This is my first time working with EU regs, so I'd really appreciate your advice!

Thank you!
 

rob73

looking for answers
#8
Hello Marcelo (and all),
Will MDR section 88 on Trend Reporting supersede the MEDDEV 2.12-1 trend-reporting requirements, or will we have to do both?
This is my first time working with EU regs, so I'd really appreciate your advice!
From what i understand all MEDDEV's will become "obsolete" after MDD is withdrawn as the MEDDEV's are specifically written to help compliance with MDD not MDR. You could still use the MEDDEV's but you need to ensure that any additional requirements from the MDR are covered.
 
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