MDR/IVDR Annex III - Technical documentation on PMS

P

Pascal VL

Registered
#1
#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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A

Ashley Fu

Starting to get Involved
#2
#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.
 
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