PMCF plan to justify that our product not require PMCF study

[Rachute]

Hi all,

I am new to the field.
We have a class IIa product, and we have some questions when drafting a PMCF (post-market clinical follow-up study for CE Marking) plan and report.
We would like to justify that our product not require to have PMCF study.

Do the items listed on MEDDEV 2.12/2 rev2, "Part 5. Circumstances where a PMCF study is indicated" already enough to justify?
What's more information that we can stuff in to the plan and report?
Shall we also add literature search (which same with in CER) into our PMCF plan and report?

Please kindly advise, Thank you.

 

[yodon]

This is a tough one, but I don't want to see it orphaned. We're all seemingly groping in the dark and stances by Tech File reviewers is somewhat all over the map.

I've had clients take what's in Part 5, make a checklist, and when all answers were 'no' (with justification), the reviewer accepted that a PMCF study was not required. Even if some answers were 'yes,' if there was adequate justification (and it had to be quite detailed), the reviewers agreed a study was not necessary.

I think you only need a Plan if a study is indicated. What we've done is say in the PMS Plan how we go about determining whether a PMCF study is necessary or not (the checklist). And if no study, no report.

Please don't take this as any guarantee! While it's worked a couple of times, like I said, reviewers are being VERY critical these days and getting more and more demanding of data supporting safety and efficacy. But if, truly, a study is NOT indicated, you SHOULD be able to justify not doing one. Just be prepared to back the assertion with good, um, data.

 

[Watchcat]

I would disagree with the reviewers who accepted the checklist. I would look to the first sentence in Part 5 as my guide:

"...the decision to conduct PMCF studies must be based on the identification of possible residual risks and/or unclarity on long term clinical performance that may impact the benefit/risk ratio."

The central question is whether the data you already have are adequate to address risks, or whether you need to collect more. (I know, I know...you might be inclined to think that, if your data are not adequate, you shouldn't be getting a CE Mark in the first place. Don't be silly. This would stifle innovation.)

The checklist just gives examples of circumstances in which your data might not be adequate. It does not list all such circumstances, and much more important, no matter what circumstances you find yourself in, it does not tell you how to figure out whether your data are adequate or not.

Lucky for many companies I'm not a reviewer. Meow.

 

[Weeder]

I think one of the things that is confusing is the difference between PMCF and PMCF study. You can perform PMCF without actually performing a PMCF study. You create a PMCF plan and carry out the activities of the PMCF according to the plan and then based on your findings fill out the checklist to say a PMCF study is not required. If the auditor observes that you are actually performing PMCF and have determined that the PMCF study is not necessary, than that should be acceptable.

 

[yodon]

That actually makes sense to me and seems to line up with the MDR. @Watchcat - the checklist is made from the list of questions found somewhere about considerations to be made for whether a study might be required. It just helps guide the collection of data to determine if one is needed and helps provide the rationale for whether one is needed or not.

 

[mboynton]

To echo Weeder, the distinction btw PMCF vs. a PMCF study comes through in Annex XIV, Part B 6.2.(a) vs. 6.2(b), in 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);

I'd interpret (a), general methods, to be blanket/ dragnet approaches, to look out for any signals that might emerge from PMCF-type data (including literature search, to OP's question). I'd interpret (b), specific methods, to be targeted approaches to get after particular areas of potential concern w/ the device (e.g., different patient or user sub-populations), or redress areas of weakness in the pre-market data.

Point (c) seems to call for making the case about whether or not a PMCF study (representing one type of a specific PMCF method that could be employed) is needed, probably based on whether there's anything specific that can't be adequately monitored through the general methods.

 

[Weeder]

mboynon has explained the PMCF concept very well. I am hoping this explanation will help a lot of people who are struggling with the issue. If only the regulatory agencies would take time to explain things in this simple straight forward way, we can all focus on making safe and effective devices rather than get mired in interpreting the requirements in twenty different ways.

 

[Watchcat]

If only the regulatory agencies would take time to explain things in this simple straight forward way

IMO, it's the regulator's job to regulate, not to tutor medical device companies (or notified bodies) on how to do their jobs. If a company doesn't understand the regulations, it needs to hire someone who does and pay for this expertise itself, rather than expecting taxpayers to subsidize their business. Same thing goes for notified bodies who do not know how to evaluate a company's PMCF. In general, I think a medical device company should know better than the regulators how to do PMCF, including whether or not a PMCF is needed as part of the PMCF for a given device, and why.

 

[yodon]

IMO, it's the regulator's job to regulate, not to tutor medical device companies (or notified bodies) on how to do their jobs.

I agree but maybe @Weeder really meant *someone* should clarify. The MDCG exists, at least in part, to give such guidance. I think it's pretty clear from the discussion that this topic could certainly use some guidance.

 

[Watchcat]

*someone* should clarify. The MDCG exists, at least in part, to give such guidance. I think it's pretty clear from the discussion that this topic could certainly use some guidance.

After mulling it over for several days, I think I'll let this one go, except for saying if "regulatory agencies" includes FDA, I'm opposed. I'll leave the EU to the EU.