Difference between general PMCF and PMS

APADO

Registered
I have a doubt on PMCF, and more specifically on Annex XIV, Part B 6.2.(a) vs. 6.2(b) and the notion of general methods vs. specific methods.

The PMCF plan shall include at least:
(a) the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
(b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
(c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);


Are "general methods" of PMCF (gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data, etc.) the same as PMS ?
 

Cloud808

Starting to get Involved
My understanding is that the activities are similar, but not the same. I tend to think of PMCF as 'Clinical PMS' (again, similar... not same). Almost as though PMCF activities are a subset of PMS activities. While the methods may be the same (i.e. search of published literature) the aim of the activities is not the same.

PMS is a reactive process -- The aim is related to vigilance. Ensuring that your device is functioning as expected throughout the lifetime of the device. This is used to inform your risk management process and identify any potential safety issues associated with device use.

PMCF is a proactive process -- The aim is to answer any questions related to the clinical safety and performance of the devices. Are there any gaps in your clinical data? Can you support device use for all indications/claims related to the device? Can you support the benefit to risk determination for the device?

I interpret PMS as a "catch-all" activity, whereas PMCF ought to be more targeted at specific questions of device use.

This is my off-the-cuff answer, so I always recommend sticking to the text of the regulation/guidance where in doubt, but I hope this helps!
 

APADO

Registered
Thank you Cloud808 for your answer !

I have almost the same understanding as you, with one exception: I consider that PMS can be proactive too (PMS: proactive and reactive; PMCF: proactive). But that is only a detail at this point: because PMCF is part of the PMS, it's about where we draw the line.

I hope this thread will keep on living, I would love to have more interesting discussions about this in the future.
 
Top Bottom