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

lisasolo

Starting to get Involved
#21
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?
 
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QM_123

Starting to get Involved
#22
Hello everyone,

I understand PMS includes PMCF, so PMCF is just a part of PMS. Actually I am not sure but I think that PMS includes all the data for both equivalent devices (for devices who marketed with equivalency claim) and also our own device. However; PMCF is just related with our own device and it is based on its clinical use data. For example, retrospective analysis of our device's own clinical data is PMCF.

So if we have to perform PMCF, we have to make a PMCF plan it must include for example study type (retrospective, prospective etc.), study population number, statistical method to evaluate the results etc. like MEDDEV 2.12 says. On the other hand PMS plan includes just the data sources i.e literature, registry databases, feedbacks from users, and PMCF results and data collecting periods. Please correct if I am wrong.

Thank you in advance.
 
#23
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’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:
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?
 

Marcelo

Inactive Registered Visitor
#25
People seems to be missing the main point of PMCF - to continuously get clinical data to update the clinical evaluation and the benefit risk determination. This comes from the identification (when the study of the recast of the directives was performed in 2005-2008) that the EU regulatory system was too light on clinical data. One of the things that was changed was a focus on measurement of benefits (where in the past the benefit/risk determination was more focused on showing that risk was acceptable, but not measuring the benefit directly) as part of clinical data, and thus the PMCF requirement simply means that these clinical data have to be gathered and evaluated thru the device lifecycle, and the benefit/risk determination has to continually show what the benefits outweigh the risks.
 
Last edited:
#26
How do you define the endpoint/population size for a PMCF study on an implant which is expected to last a lifetime? We have an endpoint of effective implantation, but how long should the follow up last? Do we need to specify the number of patients or can we specify a time frame (eg. all patients implanted between date X - date Y with 3 year follow up). Can we justify follow up time with literature from equivalent devices? CRO is pushing for (expensive) statistical analysis, but I don't understand what they are going to analyze. I'm really out of my depth will all this regulatory stuff, so appreciate any help :oops:.
 

QM_123

Starting to get Involved
#27
How do you define the endpoint/population size for a PMCF study on an implant which is expected to last a lifetime? We have an endpoint of effective implantation, but how long should the follow up last? Do we need to specify the number of patients or can we specify a time frame (eg. all patients implanted between date X - date Y with 3 year follow up). Can we justify follow up time with literature from equivalent devices? CRO is pushing for (expensive) statistical analysis, but I don't understand what they are going to analyze. I'm really out of my depth will all this regulatory stuff, so appreciate any help :oops:.
Hello Jen,

Actually the answer of population size is very complex because when determining population size you should consider lots of parameters: i.e design of your study. More participants give more clinical data, but it requires more resources , on the other hand less population may give you irrelevant data. As I know, at the beginning of designing of a study, participant size is calculated by considering lots of parameters. I kindly suggest you to get advice from a statistician who has expertise in this field. Determining study duration is also based on some statistical calculations, therefore I think that justification based on equivalent device studies are not acceptable. Additionally, for outcome evaluation you need also a statistician again, you know according to aim of study you will use evaluation method (i.e Kaplan-Meier analysis, Harris Hip Score etc. depending on your device and your study hypothesis). We decided to work with a research company on PMCF studies and clinical trials because these should perform a team which consisted of people who have different are of specialization.
 

lisasolo

Starting to get Involved
#28
Thank you @emina4, that is very helpful!

People seems to be missing the main point of PMCF - to continuously get clinical data to update the clinical evaluation and the benefit risk determination. This comes from the identification (when the study of the recast of the directives was performed in 2005-2008) that the EU regulatory system was too light on clinical data. One of the things that was changed was a focus on measurements benefits (where in the past the benefit/risk determination was more focused on showing that risk was acceptable, but not measuring the benefit directly) as part of clinical data, and thus the PMCF requirement simply means that these clinical data has to be gathered and evaluated thru the device lifecycle, and the benefit/risk determination has to continually show what the benefits outweigh the risks.
The confusing thing about the MDR describing the PMCF as the "continuous process that updates the clinical evaluation" is that we already periodically do that as part of the clinical evaluation plan.
" The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84."
So is this saying that the process of periodically updating the clinical evaluation with new clinical data is entirely through the PMCF plan? Then, it would make sense that the PMCF can include literature review and/or studies. So the PMCF plan is just the part of PMS and clinical evaluation that involves getting any new clinical data and adding it to the clinical evaluation report?
 

Ronen E

Problem Solver
Staff member
Moderator
#29
How do you define the endpoint/population size for a PMCF study on an implant which is expected to last a lifetime? We have an endpoint of effective implantation, but how long should the follow up last? Do we need to specify the number of patients or can we specify a time frame (eg. all patients implanted between date X - date Y with 3 year follow up). Can we justify follow up time with literature from equivalent devices? CRO is pushing for (expensive) statistical analysis, but I don't understand what they are going to analyze. I'm really out of my depth will all this regulatory stuff, so appreciate any help :oops:.
Hi,

Designing clinical studies (including results analysis methods) indeed requires an expertise. In a way, choosing a CRO (or "just" an independent statistician experienced in this field) is like choosing your personal physician - you have to have trust in them, at the end of the day. When you go to the doctor, you typically can't evaluate the validity of their instructions on your own. Normally you'd also follow their advice even if it's costly, because they say it's necessary, right? Otherwise why follow their advice at all?... I mean, if I don't trust a doctor, I wouldn't trust them even if the prescribed treatment costs little. Yes, you can always go for a second opinion, but that is usually costly too. So it comes down to choosing well. Invest a lot in the selection process so you can later trust the selected provider, then go with their advice. Not blindly, of course. Being thoroughly informed, with a pinch of critical thinking is always good practice. And if you're uncomfortable with your past choice (i.e. lack that kind of trust), maybe reconsider if possible.

Communication is always an important aspect of supplier selection and relationship maintenance, even more so with experts and consultants. You deserve thorough explanations in a language that you can understand, and should demand that. If your CRO is not keen to provide that, they are not worthy of your business IMO.

BTW, there are some very seasoned statisticians around here (I'm not one of them, sorry), and I think some of them have experience in clinical studies if you're looking for extra support or a second opinion. Perhaps browse the relevant forums to identify the right ones and send them a PM.

Cheers,
Ronen.
 

Marcelo

Inactive Registered Visitor
#30
The confusing thing about the MDR describing the PMCF as the "continuous process that updates the clinical evaluation" is that we already periodically do that as part of the clinical evaluation plan.
" The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84."
So is this saying that the process of periodically updating the clinical evaluation with new clinical data is entirely through the PMCF plan? Then, it would make sense that the PMCF can include literature review and/or studies. So the PMCF plan is just the part of PMS and clinical evaluation that involves getting any new clinical data and adding it to the clinical evaluation report?
Yes, that's exactly how I've been doing for years, I understand the PMCF as the part of the PMS that deals with clinical data and updating the clinical evaluation. And you can use different methods for PMCF, including PMCF studies or any other suitable methods to gather clinical data and update the clinical evaluation.
 
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