When planning PMCF, it's a good idea to align it with the CER. For example, the CER might say there is good data for the first 5 years of implant life but not so much for longer life - then you might want to gather data for more years. Or the CER might say there is good data for the general patient population, but little for patients who are high BMI, low BMI, malignancy, trauma, or whatever other characteristics might be related to a different profile of safety or effectiveness - then you might want to continue gathering data especially for patients in your special categories.
After you define the goal of a study, it's easier to think about what kinds of data you might want to look for.
------------------------------
Anne LeBlanc
United States
------------------------------
Original Message:
Sent: 21-Jan-2022 13:15
From: Anonymous Member
Subject: How to decide the Sample size/ subjects for PMCF studies for Class III implants for EUMDR
This message was posted by a user wishing to remain anonymous
Thanks for the mail.
We have clinical safety data, CER in place for the already established device.
But as per new EUMDR there is need to perform PMCF studies for Class IIi implants.
So accordingly the pmcf plan is to be prepared by taking some sites for implantation and to get the data.
Product is already approved but as per new requirement do we need to prepare PMCF .
Original Message:
Sent: 21-Jan-2022 12:56
From: Dan O'Leary
Subject: How to decide the Sample size/ subjects for PMCF studies for Class III implants for EUMDR
The first question is to determine what you are sampling. I infer that you are sampling records from some source such as a hospital or registry.
Also, what is the high cost item. The implant could be a high cost item, but the cost of sampling an individual record could be low cost.
What kind of information are you looking for based on the PMCF plan. For example, whether the device was implanted successfully, yes/or no. Alternately you could be looking at the distribution of patient age at the time of implant.
Lastly, I infer you have some questions from an auditor. Could you provide them?
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 21-Jan-2022 12:42
From: Amita Pandey
Subject: How to decide the Sample size/ subjects for PMCF studies for Class III implants for EUMDR
HELLO ALL,
Kindly give the input for how to decide the sample size for PMCF studies, how to make auditor convinced regarding the sample size calculation for the implants with high cost.