Clinical Evaluation Plan vs. PMCF Plan

yodon

Staff member
Super Moderator
#11
I guess I need to "thank" @Mark Meer for re-opening this (wound). :)

I'd like to bounce this off everyone to see if I'm maybe getting close:
  • There are 3 Plans: PMS Plan, PMCF Plan, and CE Plan.
    • The PMS Plan frames what data to collect, how to collect, etc. It's the "big daddy" of the postmarket plans and refers to the PMCF Plan and the CE Plan
    • The PMCF Plan says how the PMS data will be evaluated
    • The CE Plan describes how the PMS data, additional data, and results of the PMCF data analysis are used to make conclusions about safety and efficacy
  • There are 2 data analysis activities: one driven by the PMCF Plan and the other driven by the CE Plan
    • As a result of the data analysis, a PMCF Evaluation Report and an updated PSUR (if no clinical study indicated) is produced. Outputs could also drive product changes, Risk File updates, updates to manufacturing controls, etc.
    • As a result of the CE Evaluation (per the CE Plan), a CE report is generated.
  • Results of either data analysis activities COULD indicate that there's insufficient data to make conclusions about safety and efficacy and would drive additional clinical investigation (in which case, a PMCF Study Plan would be generated and study conducted)
I've tried to capture this in the attached visio diagram. Would GREATLY appreciate any feedback, corrections, etc.
 

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Philip B

Involved In Discussions
#12
Hi Yodon,
I don't think the PMCF plan 'says how PMS data will be evaluated'. My understanding is that PMCF is only needed if there are gaps in your data leaving your clinical evaluation incomplete. PMCF is a targeted clinical investigation and absolutely to be avoided if at all possible due to cost and complexity. For most low risk devices PMCF shouldn't be required, we specifically exclude it in our CER. Higher risk devices might need it but, again, only if there are gaps in your clinical evaluation. I think you are making this point in your third bullet?
 

yodon

Staff member
Super Moderator
#13
I think one of the confusing points is when we just say "PMCF" - it needs to be disambiguated. There's the PMCF Plan, the activities driven by the PMCF Plan (which seem to be lumped together as the follow-up activities or just PMCF), and clinical studies which I've seen referred to as PMCF Investigations (or studies).

The MDR Annex XIV, Part B says:

6.2. 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;

So that's how I came to the conclusion that the PMS Plan essentially defines the data and the PMCF Plan says how you use that data to identify gaps that may require a PMCF study to be conducted.

Admittedly, for me, it's like trying to untangle sticky spaghetti so I'm not going to assert "I'm right" by any means.
 

Mark Meer

Trusted Information Resource
#14
I think we can all agree that the text of the regulations could be more informative. I'm tending to lean toward the approach of @Philip B because, while an extrapolation of what is actually in the text of the regulations, the process does make sense logically.

The hierarchy of documentation would look something like:
PMS Plan -> PSUR
CE Plan -> CE Report
PMCF Plan (if deemed necessary) -> PMCF Study/Investigation (if deemed necessary) -> PMCF Report

Let's take a hypothetical example:

My CE plan says I'm going to look at literature, registries, and internal data related to the device or similar devices to gather data re: its safety and efficacy.
  • Scenario 1: All data supports safety and efficacy. CE report issued noting that no further follow-ups are necessary. (end process)
  • Scenario 2: In the process of CE activities, I find that there are reported adverse events for a similar device - say, an allergic reaction. Does this impact my device? This is an unanswered question, so a PMCF is appropriate. (continue process)
I now conduct a PMCF. Activities are similar to CE but with the narrowed scope of focusing specifically on data regarding effects of materials and allergic reactions.
  • Scenario 1: Data indicates that risk of allergic reaction in my device is acceptable. (end process)
  • Scenario 2: Data is inconclusive. A study/investigation is necessary. (continue process)
I now conduct a PMCF study/investigation to generate data on the possible allergic reaction to the materials in my device. This would involve a dedicated study/investigation protocol that deals specifically with my device.

@Philip B is this more-or-less the kind of hypothetical process execution you envisioned?
 
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Philip B

Involved In Discussions
#15
I think we can all agree that the text of the regulations could be more informative. I'm tending to lean toward the approach of @Philip B because, while an extrapolation of what is actually in the text of the regulations, the process does make sense logically.

The hierarchy of documentation would look something like:
PMS Plan -> PSUR
CE Plan -> CE Report
PMCF Plan (if deemed necessary) -> PMCF Study/Investigation (if deemed necessary) -> PMCF Report

Let's take a hypothetical example:

My CE plan says I'm going to look at literature, registries, and internal data related to the device or similar devices to gather data re: its safety and efficacy.
  • Scenario 1: All data supports safety and efficacy. CE report issued noting that no further follow-ups are necessary. (end process)
  • Scenario 2: In the process of CE activities, I find that there are reported adverse events for a similar device - say, an allergic reaction. Does this impact my device? This is an unanswered question, so a PMCF is appropriate. (continue process)
I now conduct a PMCF. Activities are similar to CE but with the narrowed scope of focusing specifically on data regarding effects of materials and allergic reactions.
  • Scenario 1: Data indicates that risk of allergic reaction in my device is acceptable. (end process)
  • Scenario 2: Data is inconclusive. A study/investigation is necessary. (continue process)
I now conduct a PMCF study/investigation to generate data on the possible allergic reaction to the materials in my device. This would involve a dedicated study/investigation protocol that deals specifically with my device.

@Philip B is this more-or-less the kind of hypothetical process execution you envisioned?
Exactly Mark, yes!
 

monoj mon

Quite Involved in Discussions
#16
I think we can all agree that the text of the regulations could be more informative. I'm tending to lean toward the approach of @Philip B because, while an extrapolation of what is actually in the text of the regulations, the process does make sense logically.

The hierarchy of documentation would look something like:
PMS Plan -> PSUR
CE Plan -> CE Report
PMCF Plan (if deemed necessary) -> PMCF Study/Investigation (if deemed necessary) -> PMCF Report

Let's take a hypothetical example:

My CE plan says I'm going to look at literature, registries, and internal data related to the device or similar devices to gather data re: its safety and efficacy.
  • Scenario 1: All data supports safety and efficacy. CE report issued noting that no further follow-ups are necessary. (end process)
  • Scenario 2: In the process of CE activities, I find that there are reported adverse events for a similar device - say, an allergic reaction. Does this impact my device? This is an unanswered question, so a PMCF is appropriate. (continue process)
I now conduct a PMCF. Activities are similar to CE but with the narrowed scope of focusing specifically on data regarding effects of materials and allergic reactions.
  • Scenario 1: Data indicates that risk of allergic reaction in my device is acceptable. (end process)
  • Scenario 2: Data is inconclusive. A study/investigation is necessary. (continue process)
I now conduct a PMCF study/investigation to generate data on the possible allergic reaction to the materials in my device. This would involve a dedicated study/investigation protocol that deals specifically with my device.

@Philip B is this more-or-less the kind of hypothetical process execution you envisioned?
This hypothetical example makes sense to me. In our system we are following the hierarchy in a similar fashion. Also, as Yodon has suggested, we should be careful while using the word "PMCF" and be more specific what are we talking about, PMCF Plan or Studies. PMCF Plan will (or not!) exist in everyone's technical documentation but the PMCF Interim Report and Final Report may not. In our case, we have generated PMCF plan(s) for the product(s) and justified using Decision Making Trees why our product(s) don't need PMCF Studies as stated in Annex II, 6.1(d). In the justification, along with referring to other documents, we have also referred to the relevant parts of the clinical evaluation report and risk management report as mentioned in the MDR 2017/745, Annex XIV, Part B, 6.2(d).
 

yodon

Staff member
Super Moderator
#17
I'm not seeing that a PMCF Plan is optional.

Article 10, item 3; Article 61, item 9; Article 61, item 11; etc. all talk directly to the PMCF as associated with clinical evaluation (not study).

Annex XIV Part B starts out: "PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61
and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan."

There are a few places where the MDR indicates you may be able to justify not having a PMCF Plan but it seems like that should be the exception rather than the rule.

Certainly looking forward to continued discussion.
 

Mark Meer

Trusted Information Resource
#18
I'm not seeing that a PMCF Plan is optional.
I agree. ...and this is where the strict text of the regulation doesn't jibe with the hypothetical (and IMO most logical) execution of the process I posted.

The approach that I (and others here) are leaning towards see the PMCF as activities taken if there are unanswered questions from CE. However, how do you make a PMCF plan if the scope of what you're trying to ascertain is unknown? If there are no uncertainties, then what would a PMCF Plan entail? What would be the scope?

...this is why a mandatory PMCF plan doesn't make much sense to me (though I agree that the regulation seems to indicate that it is). Perhaps an indication that my approach is wrong? :unsure:
 

Weeder

Involved In Discussions
#19
I think we can all agree that the text of the regulations could be more informative. I'm tending to lean toward the approach of @Philip B because, while an extrapolation of what is actually in the text of the regulations, the process does make sense logically.

The hierarchy of documentation would look something like:
PMS Plan -> PSUR
CE Plan -> CE Report
PMCF Plan (if deemed necessary) -> PMCF Study/Investigation (if deemed necessary) -> PMCF Report

Let's take a hypothetical example:

My CE plan says I'm going to look at literature, registries, and internal data related to the device or similar devices to gather data re: its safety and efficacy.
  • Scenario 1: All data supports safety and efficacy. CE report issued noting that no further follow-ups are necessary. (end process)
  • Scenario 2: In the process of CE activities, I find that there are reported adverse events for a similar device - say, an allergic reaction. Does this impact my device? This is an unanswered question, so a PMCF is appropriate. (continue process)
I now conduct a PMCF. Activities are similar to CE but with the narrowed scope of focusing specifically on data regarding effects of materials and allergic reactions.
  • Scenario 1: Data indicates that risk of allergic reaction in my device is acceptable. (end process)
  • Scenario 2: Data is inconclusive. A study/investigation is necessary. (continue process)
I now conduct a PMCF study/investigation to generate data on the possible allergic reaction to the materials in my device. This would involve a dedicated study/investigation protocol that deals specifically with my device.

@Philip B is this more-or-less the kind of hypothetical process execution you envisioned?
What a nice way to clarify the process. It helps me a lot.
 

Weeder

Involved In Discussions
#20
Hi Yodon,
I don't think the PMCF plan 'says how PMS data will be evaluated'. My understanding is that PMCF is only needed if there are gaps in your data leaving your clinical evaluation incomplete. PMCF is a targeted clinical investigation and absolutely to be avoided if at all possible due to cost and complexity. For most low risk devices PMCF shouldn't be required, we specifically exclude it in our CER. Higher risk devices might need it but, again, only if there are gaps in your clinical evaluation. I think you are making this point in your third bullet?
This is very true, if you have a low risk device, specially one that has been in the market for some time and you have enough data to show that your clinical evaluation is complete, then there is no need for PMCF.
 
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