PMCF plan/outcome

Galac

Involved In Discussions
Hello,

Our technical files have been reviewed a first time by our NB as part of the certification process under the new MDR 2017/745.

One of the critical remarks we had was:

"the PMCF plan should be drafted taking into account the need to have a PMCF outcome, starting from a declared statement to be included tin the CER and in the PMS plan."

At this time we have not drafted a PMCF report justifying this in the PMCF plan by:

No need for additional PMCF Evaluation report for the moment. The results of the PMCF activities are collected and analysed during the PMS reviews and in the Clinical evaluation report for which it is planned to have an updated version in May 2023 at the latest.

Additionally,
  • There were no new research questions
  • The device is not at high risk in term of clinical procedure.
  • There are no unanswered questions of, or emergence of new information on, long-term safety or performance
  • There are no post-market findings, including adverse events, which would necessitate dedicated PMCF studies
  • No risks have been identified from published literature for equivalent or similar devices which would necessitate dedicated PMCF studies
  • The device is used Worldwide and the performance and safety of the device is not likely to be challenged by exposure to a larger or more varied population
  • The medium and long term safety of the device is already established by previous use
  • Post-market surveillance activities are considered to provide sufficient data to address any residual risks
I am not sure what is expected in the end through this critical remark. Do you have any ideas?

Do you have any idea of what is ultimately expected through this critical remark?
Thank you.
 

yodon

Leader
Super Moderator
Do you have a PMCF Plan? (Sounds like you do but the remark seemed to indicate you didn't.) If so, does it address all the "methods and procedures for proactively collecting and evaluating clinical data" per the MDR? It sounds like you have at least reached some of the "aims" of PMCF.
 

Galac

Involved In Discussions
Finally i'm wondering if it will make sense to add the following contents to my PMCF plan!? What's your opinion please?

PMCF outcomes (Q&A):
- is it necessary to take preventive or corrective actions?
- Is it necessary to engage vigilance declarations or specific surveillance actions?
- Is is necessary to update the Risk Management Plan or File?
- Is it necessary to update the PSUR?
- Is it necessary to update the CEP and/or CER?
- Is it necessary to update the PMS plan?
 

yodon

Leader
Super Moderator
This is tough. I'm not sure if anybody has a good handle. Sounds like you're doing the right things. Maybe take a look at the relevant section in the MDR (Annex XIV, Part B) and map what you've done to the requirements and then ask for clarification as to why they made the remark.

Please keep us posted.
 

mihzago

Trusted Information Resource
PMCF is a separate and distinct activity from CER, PMS, PSUR, etc. (it's confusing because there's significant overlap in the information gathered an analyzed).
PMCF plan must identify specific question and data to be collected to answer that question. This information is then an input (and sometimes output) to the other reports. Saying that you're collecting the "PMCF data" as part of other activities is not going to work.
 

mihzago

Trusted Information Resource
The "PMCF outcome" is the answer to the specific question you're trying to answer with the PMCF study. For example, maybe you decided to conduct a PMCF study to gather additional data regarding device performance because the original data you used in CER had small sample size, or maybe you wanted to study longer term effects because your original data had only short-term or non-clinical data.
The outcome would be the answer if the data provides evidence that your product continues to meet the general safety and performance requirements.
 

Galac

Involved In Discussions
The "PMCF outcome" is the answer to the specific question you're trying to answer with the PMCF study. For example, maybe you decided to conduct a PMCF study to gather additional data regarding device performance because the original data you used in CER had small sample size, or maybe you wanted to study longer term effects because your original data had only short-term or non-clinical data.
The outcome would be the answer if the data provides evidence that your product continues to meet the general safety and performance requirements.
PMCF outcome would be the PMCF report then, wouldn't it? Which is strange because the NB accepts that we did not produce a PMCF report yet because the PMCF study is still in progress.
Thank you for your answer anyway.
 

Galac

Involved In Discussions
I finally asked the NB reviewer some clarifications on his Critical Finding and I would like to share his answer with you:

"My finding would only to remark the need to verifiy the PMCF plan is aligned with the CER needs.
...the finding recommend you is to review (if needed) the PMCF plan, with the aim to maintain aligned CER outcome, Post Marcket activities and Post Marcket Clinical Follow UP."

Between us, when faced with this answer, it is difficult to question ourselves. I also refer to the remarks of the NB clinical expert who finally accepted the formats and contents of our procedures, clinical evaluation file, PMCF plan, PMS plan and reports and PSUR. I hope they will be in capacity to be aligned together.
 
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