If you are not performing PMCF studies, the PMCF plan seems redundant to what is already performed in other parts of PMS. The PMS plan requires gathering information on incidents, literature, databases, registers, feedback and complaints. The PMCF plan says to include "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". This seems like the same thing, unless you are doing PMCF studies.
So how would a PMCF plan (without studies) be included in the PMS plan where you have already discussed feedback and literature?
I agree with you and have the same feeling. It is interesting how a lot of people are struggling to understand these requirements, especially if PMCF is a "new" requirement for us, meaning that we don't have experience with performing any real studies/clinical trials on our devices in the past. From the comments at the beginning of this thread, it became clear to me that next to the standard PMS process that seems we all have in place, the PMCF becomes an important part of it, it can't be ignored anymore or justified not to be done, and that you need a PMCF plan even if you don't plan to perform a PMCF
study. Also, from the regulation, in Annex XIV part B, mentioned by L_O_B on the 1st page of this thread, a PMCF study is just one method of gathering the PMCF data. PMCF study and device registry study are referred to as
specific methods, while
general methods include "clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data".
I interpret this as the possibility to setup and implement two integrated processes; one is the parent process: PMS which covers all sorts of device surveillance activities once when it's on the market; including reporting on sales, incidents, recalls, product complaints, non-clinical user feedback and complaints, feedback from e.g. workshops, exhibitions, fairs where your device has 'participated', customer surveys and so on. Within the PMS, as an integrated part of it, a PMCF process needs to be established, and this one is specialized on
clinical data on your device, so not just any data. I think that is the main distinction between these two. In line with PMS reporting, PMCF will report on clinical feedback from the market, so not just any feedback; this includes clinical experience with your product, either by e.g. interviewing healthcare professionals, writing case studies on use of your product, performing observational studies in hospitals, gathering (questionnaire) feedback from patients or doing a literature screening to gather the newest clinical data on your and/or your equivalent device's use in clinical setting. This also includes gathering any new clinical data on your device that has been generated by someone else (maybe someone included your device in their trial, this happened to us, without us knowing or hearing anything about it). Of course, as a last resort for most manufacturers of legacy devices, one of the PMCF methods would be to plan and do the PMCF study. However, when your device:
-has a documented long history of use
-when the long-term safety and clinical performance are already known
-when all the other (PMS and PMCF) activities provide sufficient data about your device's safety and performance in the clinical setting
then I think that all this data is sufficient to waive out the PMCF study. For that purpose I would use the guidance in
MEDDEV 2.12/2 rev 2, chapter 5 circumstances, cover each one of them with an appropriate rationale and conclude why the PMCF study is not indicated for my device.
That is how I see the difference between the PMS and PMCF, and if you do implement both of these processes and proactively collect and document the data for each and update the clinical evaluation and/or risk management with that data, I think that would be sufficient.
To go back to your question, I would write one plan, covering PMS where I would plan the implementation of above mentioned activities for your device, and in addition, as a part of it, include the PMCF plan into it, planning the PMCF activities. For reporting I am not sure, maybe again one report? Or a separate one for PMCF, if you end up gathering a lot of data.
Having this said, can someone please comment on this approach? Would this approach satisfy the requirements for both PMS and PMCF and would the above mentioned activities/data collection methods be enough?
I think this is exactly the 'tricky' situation I had in mind, while trying to correctly interpret the requirements. It's important to distinguish between a let's say,
light PMCF and a PMCF study. It looks to me like you 'promised' to your NB in the PMCF plan that you will do a PMCF study. Did your organization did this on purpose? if yes, to answer to your question, there are pretty clear requirements, well defined and laid out in MEDDEV 2.12/2 rev 2, on what your investigation plan should contain. And yes, it does need to cover all the tiny details such as roll-out, inclusion exclusion criteria, duration of follow-up, ethical considerations (think of getting an approval from ethical committee), informed consent and so on. Because you are planning to do the investigation involving human subjects. Here also the standard ISO 14155 kicks in.
On the other hand, in case you were planning to do a simple follow-up, similar to methods and activities I mentioned above, it still remains a question how far the NBs are or will be going in their requests as per their interpretations of the requirements. Is it really possible to 'simplify' the PMCF down to the
general methods only and satisfy the requirements?