Is PMCF really a continuous activity per Annex XIV,Part B?

DamienL

Involved In Discussions
#1
Hi all,
I realise this has been touched on quite a bit already, but there seems to be conflicting opinions on how to handle PMCF, so just hoping someone can put me straight before my head explodes.

First off, comments in some of the threads (like this one: Clinical Evaluation Plan vs. PMCF Plan) seem to suggest that the Clinical Evaluation drives a decision as to whether or not PMCF activities are required. My understanding of the discussion is that in situations where the Clinical Evaluation raises specific questions that may impact the existing benefit/risk ratio, then this tells you that PMCF is required and so you need to generate a PMCF plan to look into it further. On the other hand, if no such safety/efficacy questions arise in the Clinical Evaluation, then you can you just ignore PMCF activities altogether (at least until new info comes to light that would force you to re-evaluate). But until that happens we can just move through the product's life-cycle without any PMCF plan/evaluation/report (using a justification as seems to be invited per Annex II 6.1(d)).

But then there's some really good disucssion which seems to contradict this approach, like in this thread: Interesting Discussion - PMCF (Post-Market Clinical Followup) vs PMCF studies. This seems to suggest a PMCF process is always (mostly?) necessary and that a PMCF plan is continuously being adhered to in the background, like with PMS. The first approach makes more sense to me, as I don't quite get what a PMCF plan without PMCF studies would give you that couldn't be captured through the Clincial Evaluation plan. Leaving that aside however, this 2nd approach does seem to tally closer to the letter of the MDR, so I'm concerned that the first approach could be viewed as non-compliant (even though I think it would get you to the same end result with one less round of plans/reports).

So I'm wondering what people generally do - in cases where the Clinical Evaluation is saying everything's good, nothing to see here, would you simply justify no PMCF? Or would you still generate a PMCF plan and periodic reports regardless? Or maybe the MDR is sufficiently vague/confusing that you could use either approach until consensus practice emerges?

Thanks in advance,
Damien
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#2
Hi Damien,

I think one general problem is that PMS, PMCF and clinical evaluation overlap to a certain degree. There is no clear definition what specific activities belong to which process. But, it seems clear that PMCF does encompass more than just PMCF trials. Does literature research fall under PMCF? Or search in CA databases?

In my personal opinion, I would structure it like this (under MDR):
The PMS plan contains the obvious PMS activities, and a PMCF part which always covers some clinical avtivities. The type and intensity of these activities is basically dictated by the outcome of the CER. They can range from user surveys to full fledged clinical trials. But, under MDR, I would always have something ongoing, that seems to be the intention of the regulation. And the PMS- or PMCF-report describes the results, while the CER evaluates the results and puts them in perspective, and also drives the PMCF intensity of the next round.

A justification for no PMCF could, in my personal opinion, only be possible for class I or class II products where you really have a lot of current information from the market, and/or that are well established (like regular surgical instruments, basic endoscopes, IR thermometer etc).
 

RobertvanBoxtel

Involved In Discussions
#3
@DamienL @Raisin picker
Excellent discussion! Article 61 addresses both the clinical evaluation and PMCF requirements, and this is further detailed for both in Annex XIV. The regulator considers it to be one process, as described by @Raisin picker. Further, as PMCF provides feedback on the product in the real world, it is considered by the regulator to be part of PMS activities (see Annex III). So we got that worked out.

Now the next part: what is PMCF? Contrary to PMS, there is no definition of PMCF in article 2. However, it is mentioned in the definition of clinical data:
‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
— clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.

Furthermore, in none of these lines it is mentioned that PMCF equals PMCF study/trail/investigation, although we can agree that PMCF studies are part of PMCF (and therefore PMS).
Following Article 61.11, we move to Part B of Annex XIV. And there we read that PMCF shall be understood to be a continuous process that updates the clinical evaluation (as indicated by both of you). Input-output, you know the drill. Oh, and by the way, this process needs to be planned (PMCF plan). You as manufacturer must determine the methods, identify what data comes out of that and argue why that is a valid method to gather that type of data (this is my summary of the "heavy" words used in Annex XIV section 6). Don't forget - the data gathered shall be reported on (PMCF Report) and demonstrably feedback in the CER. (Again input output etc).

The million dollar question (because you don't want to also do this - so burdensome...): Can we not just argue that PMCF is not needed?
My reply: where does it state that PMCF can be omitted (with justification)? Not in these sections of the regulation! So default mode should/could/must be (for now, as we are all starting up our systems under the MDR): DO IT! Make a PMCF plan! Ensure that a report will be made and that the CER's will be updated!

I can hear you say: But our devices are already on the market for so long! Good for you!
But not from regulatory point of view. Because the MDR is not there yet for years... And the MDR contains newly the concept of safety and performance in combination with BENEFIT. And I challenge you all to demonstrate that that was in focus of your CERs / PMCF / PMS etc in the past. So I repeat my point: PMCF: DO IT! Always with in the back of your mind: PMCF does not equal PMCF study, so there are more ways (read methods) to gather clinically relevant information.

There is one possible option to justify not to perform PMCF. If you have a device for which gathering clinical evidence / clinical data is not deemed appropriate (Art 61.10), and you can demonstrate the side conditions in Art 61.10, PMCF is also not possible. And you can include a justification thereoff in your CER (STILL NECESSARY) and in your STED. This is not my personal opinion, this is validated by NB's. I am working on possible criteria for products that can follow Art 61.10, and presented on that with a NB during the last RAPS Euro Convergence.
 

DamienL

Involved In Discussions
#4
These are both excellent replies, and I am (almost) convinced. But before I completely give up on no PMCF, I just want to play devil's advocate for a minute.

In situations where you're not going to be doing PMCF trials, but you're going to continuously collect Clinical Data, then why can't your PMS system seek out that "clinical data" (your PMS Plan would define the same methods and criteria as would be in the PMCF Plan) but feed it straight back into the Clinical Evaluation instead of into a separate PMCF Evaluation report. From what I can see, the PMCF Report just feeds back into the CE Report anyway, so why is it required as a standalone report? Can't the Clinical Evaluation report just do the same job?

Per article 2, definitions: clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended

And there's kind of a definition of PMCF at the start of Annex XIV part B: "to proactively collect and evaluate clinical data of a CE Marked device 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 bits I've highlighted in blue seem to reinforce that it's part of the PMS system. The bits in red seem (to me anyway) to completely overlap with what the Clinical Evaluation's job is, so why is a separate PMCF Evaluation report needed? Would the CE report not just be regurgitating all the stuff from the PMCF report?
 
Last edited:

RobertvanBoxtel

Involved In Discussions
#5
Again, spot on! Your thoughts - very practical - are the same as mine.
Can you feel the next word coming?
However.
Terrible word. But, unfortunately, there is a However.

Annex XIV section 7 is very clear:
7. The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.

Hence: PMCF report is a requirement. The regulator enforces such a PMCF report.
And, has actually created 2 MDCG documents (PMCF plan and report) for this. In pdf. Just so that it is not possible to copy paste it or fill it in. To make our lives so much easier.
And: NB's, during their MDR audits/file reviews are making requests for a PMS plan and a PMCF plan.

Of course they can be combined. Which would be practical. To which the typical NB reviewer/auditor would (informally) agree.
Unfortunately, NBs are forced by their Competent authority to demonstrate that they have reviewed 2 separate plans. And eventually also a PSUR and PMCF report.

So, strong recommendation: Make for both processes a plan and report... and, make a word version of the MDCG PMCF plan/report that contains those elements identified, but in a template that works for you as a company.
 

DamienL

Involved In Discussions
#6
Thanks Robert, this is very helpful advice and I will definitely be following your recommendations on this. However, from Annex II, 6.1(d) PMCF is NOT an absolute requirement. So I do think there is still a case for not doing PMCF, and that it could be based around low residual risk for certain devices. But at that stage you're probably fighting a rearguard with your NB, so I for one will be going with your recommendations above. Thanks again.
 
Thread starter Similar threads Forum Replies Date
K MDCG 2020-7 PMCF Plan Similar Devices EU Medical Device Regulations 0
S PMS (Premarket Submission) and PMCF Plan EU Medical Device Regulations 5
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 33
A CE Mark and PMCF study EU Medical Device Regulations 3
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 6
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
R PMCF - centers/countries used CE Marking (Conformité Européene) / CB Scheme 0
R PMCF plan to justify that our product not require PMCF study EU Medical Device Regulations 9
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 9
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
W Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies EU Medical Device Regulations 39
B PMCF study plan is same to clinical investigation plan? EU Medical Device Regulations 3
S Do subjects pay for a medical implant in PMCF study? Quality Manager and Management Related Issues 3
C PMCF (Post Market Clinical Followup) Enrollment Sizes (Spinal Implants) EU Medical Device Regulations 5
Q Is there a way that I can combine two PMCF studies into one? EU Medical Device Regulations 4
B Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies EU Medical Device Regulations 3
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
L Residual risks which the PMCF study is based on ISO 14971 - Medical Device Risk Management 7
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
D As a newcomer to QMS, I really appreciate how ISO is set up. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Is it possible to start an ISO 9001 QMS from scratch (Really) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
K GDPR - Is it really necessary for the DPO(s) to be knowledgeable to Data Privacy Law? IEC 27001 - Information Security Management Systems (ISMS) 3
W Is the RPN (risk priority number) in the PFMEA really a RPN without the detectability ISO 14971 - Medical Device Risk Management 4
H CQA Exam - Do I really have to go five hours without a drink? Professional Certifications and Degrees 4
DMLqms Medical Device Expiry Date or Manufactured date - really? Other Medical Device and Orthopedic Related Topics 1
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
Q Really do they add value (Vision, Mission, Values)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Do we really need a traditional Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J ISO 17025 testing laboratory - Receiving lab supplies - What really needs a C of A? ISO 17025 related Discussions 2
Q Is Medical Device 510(k) exempt or not really exempt? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Marc What Airlines Really Charge (In 1 Simple Table) Travel - Hotels, Motels, Planes and Trains 6
H Is 5S really that good? Lean in Manufacturing and Service Industries 34
P What is a QMS (Quality Management System), really? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Chennaiite Do Attribute Control Charts really help? Statistical Analysis Tools, Techniques and SPC 9
K Customer Audit - Just a positive rant really General Auditing Discussions 2
M "Value", A product that really meant something to you Coffee Break and Water Cooler Discussions 15
WEAVER Is GR&R really practical for a Measurescope? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Jim Wynne A Lame Phishing Email--Are we Really This Gullible? After Work and Weekend Discussion Topics 16
J Does a Lower Thermostat Setting really save Energy? Coffee Break and Water Cooler Discussions 11
AnaMariaVR2 What Do Flight Attendants Really Think of You? Travel - Hotels, Motels, Planes and Trains 0
N Does Debt Consolidation Really Help Your Credit Score? Coffee Break and Water Cooler Discussions 7
L CE Mark - but not really. What are consequences? CE Marking (Conformité Européene) / CB Scheme 3
T The best way to pull some meaningful stats from a really big project? Using Minitab Software 3
L Do I really need to be AS9100 certified? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
B Is Immediate Action really necessary before a Corrective Action? Nonconformance and Corrective Action 7
B Is accreditation to ISO 17025 really necessary? ISO 17025 related Discussions 15
V Really Urgent: Error in Minitab Using Minitab Software 8
R What does the Programmable Electrical Medical System really mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
J Are these things really required in a document control procedure? Document Control Systems, Procedures, Forms and Templates 17

Similar threads

Top Bottom