Clinical Evaluation Plan vs. PMCF Plan

[Mark Meer]

I'm a bit confused as to reason for the distinction between a Clinical Evaluation Plan, and a Post-Market Clinical Followup (PMCF) plan, as specified in MDR Annex XIV, Part A and B, respectively.

It seems to me that these are sufficiently related so as to be succinctly encompassed in a single document.

How are others documenting these plans?
If as separate documents, why? Is there not a lot of overlap between the two?

 

[shimonv]

Generally speaking - it's hard to make sense of EU regulation, not to mention effectiveness
Clinical evaluation plan is essentially search & review exercise plan. It is a must under MDD/MDR.
Post-Market Clinical Followup is essentially a post-market clinical investigation plan. It is not a must under MDD/MDR. You do it when clinical evaluation is not sufficient to confirm the safety and performance of the device.

In my Post-Market Surveillance System SOP - I refer to both processes.
In the PMS plan - I refer to both processes.
The execution - clinical evaluation and investigation are done separately.

Cheers,
Shimon

 

[Philip B]

My understanding is that when you have completed your clinical evaluation, there could be gaps in your data; therefore you plan PMCF to fill those gaps.

 

[Mark Meer]

Thanks for the replies. ...but I'm still confused why there is a distinction (forgive me!), and interpretations here on the Cove appear mixed.

For example, in this thread, it is suggested that the Clinical Evaluation Plan is simply what is done initially (pre-market), and then is updated continually post-market according to the PMCF plan. Others seem to infer that the PMCF is an investigation to gather additional data over and above the clinical evaluation, but from my reading of the regulations, the PMCF doesn't necessarily entail an investigation/study, in which case, like I say, it seems like the same thing as the continually updated clinical evaluation.

If you were to just document a single "plan" that states that at given intervals throughout the lifetime of the device (from design to post-market) you will evaluate available data on the device and similar devices (and you give objectives, sources, criteria, rationale, etc.), would this not serve as both a Clinical Evaluation Plan and a PMCF plan?

 

[Philip B]

MEDDEV 2.7/1 provides guidance on PMCF such as:
"d. Determine PMCF needs; In order to determine needs, the evaluators should describe residual risks and any uncertainties or unanswered questions. The evaluators should also include aspects such as rare complications, uncertainties regarding medium- and long-term performance, or safety under wide-spread use. "
However, if you manufacture low risk devices (like us) you probably don't do clinical investigations, possibly don't have any significant gaps in your clinical evaluation and therefore don't need to do PMCF. Just keep your clinical evaluation up to date with results from PMS and new sales/complaint data etc (and have a procedure/plan that says how you will do this).

 

[Mark Meer]

Thanks for the reference @Philip B.
But I gotta say, the regulations are terribly unclear. There is no indication that the PMCF process is intended to be supplementary to the clinical evaluation when there are "unanswered questions", and if there are no such uncertainties then a PMCF is unnecessary.
Geez...if this is indeed the intent of PMCF, it'd be so simple to convey this in the text of the regulations themselves.

 

[shimonv]

Mark,
You are too good for MDR
The MDR is almost intentionally ambiguous.

The following is the first paragraph from Annex XIV, PART B ,POST-MARKET CLINICAL FOLLOW-UP

"5. 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. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence."

The clinical evaluation is being updated with the results of clinical use of a device bearing the CE mark with the same intended use.
The phrase "clinical data" as defined in Article 2 (48) refers to clinical investigations and other published reports and relevant information.

To make intelligent distinction (i.e. making sense out of nonsense) we treat PMCF Plan as referring to clinical investigation plans whereas the clinical evaluation plan is the upper layer that includes both data from litrature review and the clinical trials.

 

[Raisin picker]

To throw in another opinion:
"When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data ..."
PMS is typically reactive*, you collect customer complaints and compare to sales data or examine explants. You get feedback on trade fairs or from marketing.
PMCF has to be active. Of course, a clinical trial is active, but other activities can be part of the PMCF as well. This could be questionnaires to customers (both medical and patients). Literature search and competent authority database search also falls in this category. Surgery reports from your team or your key partners.

*of course, PMCF is considered to be part of PMS, so sthis statement is not exactly correct.

 

[Raisin picker]

This week, two MDCG-documents have been released regarding PMCF: MDCG 2020-7 and -8. I'm too new to post a link, but you should be able to find it easily.

 

[yodon]

This week, two MDCG-documents have been released regarding PMCF: MDCG 2020-7 and -8.

Thanks for the heads up, @Raisin picker - both can be found here: Guidance - Internal Market, Industry, Entrepreneurship and SMEs - European Commission