Hello,
I'm new here, I tried to find the answer to my question in the posts but unfortunately I didn't find it. I apologize in advance for my English.
Is PMCF the same as PMCF studies? Everywhere I find a plan for PMCF studies that plans clinical trials. I am confused. Can I turn off this plan if literature review and side effects are in the PMS plan? Can I write a PMCF plan that takes into account the same data as collecting literature, adverse events, etc. NB asks me the clinical follow-up plan .. I don't know how to solve it. (medical devices, class IIb)
Thank you in advance for your explanation
I'm new here, I tried to find the answer to my question in the posts but unfortunately I didn't find it. I apologize in advance for my English.
Is PMCF the same as PMCF studies? Everywhere I find a plan for PMCF studies that plans clinical trials. I am confused. Can I turn off this plan if literature review and side effects are in the PMS plan? Can I write a PMCF plan that takes into account the same data as collecting literature, adverse events, etc. NB asks me the clinical follow-up plan .. I don't know how to solve it. (medical devices, class IIb)
Thank you in advance for your explanation