Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies

[W3r0nika]

Hello,
I'm new here, I tried to find the answer to my question in the posts but unfortunately I didn't find it. I apologize in advance for my English.
Is PMCF the same as PMCF studies? Everywhere I find a plan for PMCF studies that plans clinical trials. I am confused. Can I turn off this plan if literature review and side effects are in the PMS plan? Can I write a PMCF plan that takes into account the same data as collecting literature, adverse events, etc. NB asks me the clinical follow-up plan .. I don't know how to solve it. (medical devices, class IIb)
Thank you in advance for your explanation

 

[FoGia]

Hello,
It's unclear what you refer to as 'PMCF', I can only think of PMCF plan, PMCF report or PMCF studies.
The PMS plan is not the same as the PMCF plan, rather a PMCF plan can be included in a PMS plan. PMCF studies are clinical investigations and not literature reviews or reported AE's. MEDDEV 2.12/2 rev2 also defines what is understood by a PMCF plan.
Your PMCF plan should be made in consideration of the output from your clinical evaluation.

 

[W3r0nika]

In meddev is described the investigation plan that is the same as the PMCF plan?
If not what should the PMCF plan contain?

 

[L_O_B]

Hello W3r0nika,

A study is just one way of gathering PMCF data.
An investigation plan is completely different from a PMCF plan.
From regulation 2017/745 Annex XIV part B:
"PMCF shall be understood to be a continuous process that updates the clinical evaluation [...]
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);
(d) a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I;
(e) the specific objectives to be addressed by the PMCF;
(f) an evaluation of the clinical data relating to equivalent or similar devices;
(g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and
(h) a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer."

 

[W3r0nika]

Thank you, just for example, point a) is like the one in PMS and this confused me a bit. Maybe the PMS plan is not the best either? I put in the annex how it looks [template]

 

[FoGia]

The template will certainly not stand in regards to the requirements laid out in the MDR:
The post-market surveillance plan drawn up in accordance with Article 84. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.

1. The post-market surveillance plan shall address the collection and utilization of available information, in particular: - information concerning serious incidents, including information from PSURs, and field safety corrective actions; - records referring to non-serious incidents and data on any undesirable side-effects; - information from trend reporting; - relevant specialist or technical literature, databases and/or registers; - information, including feedbacks and complaints, provided by users, distributors and importers; and - publicly available information about similar medical devices.
2. The post-market surveillance plan shall cover at least: - a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market; - effective and appropriate methods and processes to assess the collected data; - suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I; - effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; - methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; - methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users; - reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86; - systematic procedures to identify and initiate appropriate measures including corrective actions; - effective tools to trace and identify devices for which corrective actions might be necessary; and - a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

Yet for your purpose you may probably not need to go as far as what is described in the MDR(for the moment).

 

[W3r0nika]

Thank you for the explanation
Eh, so everything is done wrong ...
Could someone submit a template for PMS plan or PMCF or something?

 

[W3r0nika]

I have one more question,
which means (b) the specific methods and procedures of PMCF to be applied, such as evaluation of appropriate registers?

 

[FoGia]

I don't have a PMS or PMCF plan to share, in a few months a guidance on PMS related to the MDR should be released that may provide you with more guidance.
Your PMCF needs will define what type of clinical are most appropriate for your device. My understanding from point (b) is that you have to define your needs precisely(such as the setup of clinical data from a register) so that you'll be able to evaluate afterwards the quality of your output.

 

[Rincewind]

Hello,

I am trying to analyse (and writing a rationale) if a device needs PMCF studies therefore I decided to take the MEDDEV 2.12/2 and analyse each of the 17 points of the circumstances where a PMCF study might be indicated (chapter 5, p. 9-10).

I have trouble understanding the point:
Circumstances that may justify PMCF studies include, for example:
-continued validation in cases of discrepancy between reasonable premarket follow-up time scales and the expected life of the product;

Can someone maybe shed some light on this?

I read this as: A PMCF might be indicated if a device is used much longer than initially anticipated by the manufacturer?