Hello,
I really need some help with this issue I've been tackling. We have CE marking for a Class IIb medical device, but there is a push to have some units modified for a PMCF study (on patients). They do not want to get into clinical trial territory, and I am being told that the (software) changes are minor. Basically, the company received feedback that one of the device modes had a bit too much energy for how the surgeon wanted to apply it. He wanted the mode to be similar to how a previous model performed. Our company now wants to modify the unit said surgeon has (by tweaking some of the software parameters) to grant the surgeon the output he's looking for. The device still remains within the intended use and does not alter safety/efficacy. The company also wants to create additional units of the same configuration for other surgeons in the field to try out and give feedback on. But this is not a wholesale change to every unit that we produce from now on, which would of course require an update to the technical file. This is just for a small amount of units. I don't know how this would be done appropriately because even though it could be fine if pushed as a minor design change, the fact remains that these units are different (will have a different software version) from what is approved in our technical file. The only thing I can think is to of course do proper design control, V&V, risk management, etc. so that they are sound, but to have phenomenal tracking of these units, construction, versions and locations in our PMS documentation (i.e. PSUR or PMS reports). I know this may not be enough context, but this has been driving me mad. I will provide additional info as I'm able, but could someone please help clarify whether or not this is even doable as a PMCF and provide justification?
Thank you very much,
B_Cologne
I really need some help with this issue I've been tackling. We have CE marking for a Class IIb medical device, but there is a push to have some units modified for a PMCF study (on patients). They do not want to get into clinical trial territory, and I am being told that the (software) changes are minor. Basically, the company received feedback that one of the device modes had a bit too much energy for how the surgeon wanted to apply it. He wanted the mode to be similar to how a previous model performed. Our company now wants to modify the unit said surgeon has (by tweaking some of the software parameters) to grant the surgeon the output he's looking for. The device still remains within the intended use and does not alter safety/efficacy. The company also wants to create additional units of the same configuration for other surgeons in the field to try out and give feedback on. But this is not a wholesale change to every unit that we produce from now on, which would of course require an update to the technical file. This is just for a small amount of units. I don't know how this would be done appropriately because even though it could be fine if pushed as a minor design change, the fact remains that these units are different (will have a different software version) from what is approved in our technical file. The only thing I can think is to of course do proper design control, V&V, risk management, etc. so that they are sound, but to have phenomenal tracking of these units, construction, versions and locations in our PMS documentation (i.e. PSUR or PMS reports). I know this may not be enough context, but this has been driving me mad. I will provide additional info as I'm able, but could someone please help clarify whether or not this is even doable as a PMCF and provide justification?
Thank you very much,
B_Cologne
