All Post-marketing studies = PMCF?


Hello all,

Simple question for the smart people of this forum. We are conducting a few global studies using our CE marked, Class IIb device, that I am preparing the PMCF Plan/Report for. In one of the studies, a different device (also manufactured by us) is used in addition to our Class IIb device, and the whole point of the study is to assess the safety and performance of that different device. The Class IIb device is still used in accordance with its CE marked indication in this study.

Do I have to call this out as a PMCF study? I would like to leave it out with the justification that it does not provide any data that addresses gaps in the clinical evidence (that are not otherwise addressed by other studies). Can I just reference this study in the CER as a sponsor-initiated study and cover the safety/performance there? Or are any sponsor-initiated studies using a particular CE-marked device required to be called a PMCF study?

Thanks in advance!


Sorry, coming to this question a bit late but I am looking for the answer to this question too. Did you come to any conclusion or resolution @partyhats?

In my previous companies we have considered ALL post-market activities with potential clinical performance or safety outcomes = PMCF. As such we have been very careful what activities we initiate as we know that the data will need to be reported regardless of positive or negative outcome.

However, in my current company they have a distinction of Specific PMCF activities which we include in our PMCF Plans that are intended to generate specific data to fulfil a specific PMCF need, versus 'other' post-market activities for other purposes like commercial interest or just where the device has been included as a secondary device (still within scope of its intended purpose & CE mark), which are not included in the plan or typically reported. A lot of these activities are retrospective data collection where we do not know the quantity or quality of the data we will receive. The company like to wait to look at the data to see if it adds any value before they consider reporting it in the technical documentation. As a result of this distinction the company have historically initiated a lot of these kinds of activities as a 'look-see' but they have not consistently been reported, other than following up on complaints and AEs as standard procedure. Other scenarios may be that the activity is just funded by the company but we are not sponsoring the study and have no control over its conduct. Some of the clinical partners we work with/independent clinicians we fund can be slow to provide the final study deliverables.

This inconsistency in reporting has caused some problems in our PSUR reporting and questions from our Notified Body, so I am unclear if the Notified Body perceive the same distinction.

In my personal professional opinion, all post market clinical activities that have any potential output that relate to the performance or safety of the device fall under the scope of PMCF, and should be included in the PMCF Plan and reported in the PSUR and CER, to ensure transparency. Otherwise my concern is it could appear that we are cherry-picking what data we report, even if that is not the intention.

My colleagues disagree with me, as they say that for some of these activities where we do not know the quality of the data we will receive and cannot control the timeline we do not want to make a commitment to the Notified Body to follow though with the activity by including it in the PMCF Plan.

Please does anyone else have experience with a similar issue, or could provide some insight of what is the 'right' distinction for specific PMCF and what we should be including and reporting in the PMCF Plan and PMCF ER? Should we be including every clinical activity, or can a distinction be made for 'other' clinical activities with the device to not be included as PMCF?


Involved In Discussions

I think that adding the concept of clinical data weighting in your clinical evaluation report could be usefull.

I would handle clinical data coming from external sources (i.e. not from the legal manufacturer) and not being part of your proactive PMCF activities as literature data ('reactive' data) with a low weighting compared to your PMCF results. The idea is to decrease their contribution to the overall clinical evaluation. Further rational on this low weighting may be needed but the fact that you have no control on the data is a first good one.

Data coming from sponsored investigations involving your device as a secondary device is a more tricky situation. I've never faced it but I would say that if the defined efficacy endpoints are unambiguously applicable to the secondary device, results shall be considered part of your PMCF activities with a high weighting, and if it's not, I would either remove the results from the device REC or consider them with a low weighting.
But my feeling regarding the first case (unambiguously applicable to the secondary device) is that the endpoitns were not adequately defined, otherwise how do you objectively assess the efficacy of the main device ?

Hope it helps,
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