Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies

FoGia

Involved In Discussions
#11
I interpret as: the data you produced pre-market doesn't cover the full lifecycle of your device.
Example: you have an implant with a lifecycle lasting 20 years but your had only 2 years follow-up data when placing the device on the market, hence the need to complement your clinical data with studies recording a longer follow-up.
 
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#12
hello
sorry about my English. i am new in the medical devices sector. i work at a company that manufactures medical devices class IIb. we are at the initial assessment for CE mark and the NB ask me the PMCF plan. if our products don t have yet a CE mark and we make the clinical evaluation based by literature do we need a PMCF plan?
Thank you.
Have a nice day
 

FoGia

Involved In Discussions
#13
It depends on your device, on the risks, on the claims you want to make. As mentioned above in the thread you can refer to MEDDEV 2.12/2 rev 2 to give you some guidance. And yes you need a PMCF plan even if you don't need to perform PMCF studies.
 

Wolf.K

Quite Involved in Discussions
#15
MEDDEV 2.7.1/Rev. 4 mentions: clinical investigations = clinical studies (definitions section), but also PMS studies (6.1) and PMCF studies (6.2.1). Does not really help to get NOT confused...
 

W3r0nika

Starting to get Involved
#17
I still have a problem with understanding what the PMCF is.
It seemed to me that it could be all the market information that is affecting the update of the clinical evaluation. For example, collected reports of surgical procedures using our devices or medical incidents that bring new risks and need to be updated and risk and clinical assessments updated.
I also heard that the PMCF is only for implants.... ??
Please give me some advice....
 

Wolf.K

Quite Involved in Discussions
#18
PMCF is part of PMS, and is mandatory for all medical devices (not only implants). The clinical evaluation has to be updated continually, as new information is gained. As (still) many products are released to the market according to the equivalency principle, it is now required to actively collect clinical data of the devices. This was also true for the MEDDEV guidance, now it is not in the guidance but in the law itself. For class III now it is mandatory to perform PMCF clinical investigations if no clinical investigation was performed prior to market release. (This is not possible anymore in the future - equivalence is not sufficient anymore for products.) My company e.g. has currently six clinical studies running at different hospitals for different application areas of our medical device, as we noticed, that it was not used as recommended in the IFU.
 

Highground

Involved In Discussions
#20
I’m a bit frustrated with an NC for our PMCF plan on a device that is an IIb. NB wants to see a plan that lists what healthcare facilities we are going to use on roll-out, dates, investigators, follow-up on patients. It’s a heart/lung machine, it pumps blood. I put the planned facilities, but it changes according to need. I really do wish the PMCF requirement was more defined when the devices are not implants or class III devices. I think the NB's get confused about the interpretation. :bonk::bonk::bonk::bonk:
 
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