B
According to POST MARKET CLINICAL FOLLOW-UP STUDIES MEDDEV 2.12/2 rev2, PMCF studies are required.
But, from section 5, it have sentence
“PMCF studies may not be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks.”
As our CE product is
We also have the feedback system to
Alternatively, we plan to do some review based on page 5 on “Circumstances that may justify PMCF studies” to conclude no such circumstances for our CE products.
May I know if the above action is enough or not ?
I would greatly appreciate it if anyone kindly give me some feedback or suggestion.
Thanks in advance !
But, from section 5, it have sentence
“PMCF studies may not be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks.”
As our CE product is
- very low risk hand-held, internally battery, home-use, Class IIa medical device,
- Clinical studies are also well developed in the past 30 years,
- No recall & adverse report for our products
We also have the feedback system to
- check updated standard regulation &
- post-market surveillance of similar product from market, such as “any recall & adverse report from FDA”
Alternatively, we plan to do some review based on page 5 on “Circumstances that may justify PMCF studies” to conclude no such circumstances for our CE products.
May I know if the above action is enough or not ?
I would greatly appreciate it if anyone kindly give me some feedback or suggestion.
Thanks in advance !