Management review questions

1. risk policy that is referred to in the template - what is this exactly? is it the risk management policy according to ISO14971 or is it a general risk assessment for the policy? how exactly can it be evaluated during management review?

Yes, it is risk management policy according to ISO14971, the manufacturer needs to state policy for establishing criteria for risk acceptability. How it must be composed is stated in the ISO /TR 24971:2020 Medical devices — Guidance on the application of ISO 14971.

During the Management review, you will check whether the risk policy must be changed due to complaints, possible withdrawals, or reported adverse events and whether it is necessary to change the eligibility criteria.

2. the matrix of KPIs - is it ok if timewise it is approved during the first MB meeting, or does it need to be prior (in our case, 3 months prior when the SOP was established) and presented to the management for review?

KPI is best to approve prior, so that you can discuss it in your Management review and that you can even assess what goals you will set for the next period after the Management review.