MDR/IVDR Annex III - Technical documentation on PMS

#1
Dear experts,

We are struggling with 2 requirements from Annex III related to PMS in the MDR/IVDR:

The PMS plan shall cover at least:

1) suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management.

We really would appreciate if someone could give practical example(s) of suitable indicators and related threshold values.
We doubt if it is related to the PMS-input or if it is related to already identified risks (output of PMS) affecting the SOD-scores (indicator) and consequently the RPN-value (threshold).


2) methods and protocols to manage the events subject to the trend report as provided for in Art. 83, including methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents.

Is it sufficient to only analyse the trend of the ratio #complaints/#orders during a specified period? Or should this be done for more inputdata?


Thanks you for any feedback
 
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#2
I also foucus on the PMS. It's really difficult to eatablish a specified PMS plan AND a PMS system for me.:read: Maybe I haven't thoroughly undertood the requirement in the guidance.
 
#3
Maybe it's quite late now and you might have already established.

But here are the examples you wanted -
> suitable indicators - Implement Nelson rules (there are 8, you may choose the common ones) in the U-chart, using the Nelson rules you can see the adverse trends and that will serve as suitable indicators.
> threshold values - Use U-chart and the upper & lower control limits will serve as the threshold values

* Train someone in basic statistics or you can outsource (message me if you need help).

Regards,
Paul
 
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