Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies

B

bennylee

#1
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
  • 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 conclude that medium/long-term safety and clinical performance are already known from previous use of the device.


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”
Hence, we do have some methods to address the extra risks if any.


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 !
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#3
It is very difficult to be certain of an answer without full details, from the limited information provided it appears that your rational is sound
 
B

Blitzen

#4
You may need to write a clinical evaluation based on the literature available, you do not need to initiate a PMCF study
 
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