Which MDCG Document should I use for PMS Plan and PSUR?

perigulec

Registered
I need to prepare PMS plan and PSUR according to MDR for our Class 2a and 2b devices. Is there a standard template for these? Looking forward to your help, thank you.
 

Mhill9

Registered
For PMS there is an ISO/TR guidance: "ISO/TR 20416;2020 Medical Devices – Post-market Surveillance for manufacturers"
 
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