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PMCF study plan is same to clinical investigation plan?

B

BreeJeong

#1
Hi there!:bigwave:
I'm getting a lot of help from here. Thank you, everybody!

I am not good at English. so please understand my English mistake :)
I have worked as a medical device RA only two years.

CE TCF of an orthopaedic implant (Class IIb) have been auditing since June 2016 by a notified body. It's not finishing yet. Last months, I received 2nd round of comments from my NB.

They said it is not clear that we have a PMCF study plan, and suggested clinical trial plan should be needed.
I prepared and summited a PMCF plan and a PMS procedure. so I have confused.

1) Are PMCF plan and PMCF study plan different?
2) If not the same, what are the differences? PMCF study plan is same to clinical investigation(clinical trial) plan?

I look forward to somebody's answer.
thank you for reading my questions :)
 
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#2
Hi BreeJeong, welcome to the Cove!

The PMCF plan is the planning of activities to collect relevant data in order to support compliance with essential requirements (p. 49 of MEDDEV 2.7/1 rev 4). Part of a PMCF plan can consist of clinical trials.
A clinical investigation plan (CIP) is the study protocol of such a clinical trial (as described in ISO 14155).
 
#4
Good question - it's very easy to get these aspects confused, however it's also really important to understand the differences. A PMCF Plan sets out your overall plan for how PMCF will be structured for the device. This includes, for example, a declaration of objectives for the PMCF system, and a description of how these objectives will be met.

One objective might be that Clinical Studies will be performed to gather data necessary to achieve these objectives. This is where a PMCF Study Plan comes in. A Study Plan (or Clinical Investigation Plan / Protocol) lays out a procedure for conducting a particular clinical investigation. A PMCF Plan may set out a need for several studies, each of which will need a Study Plan.

So, hopefully from this you can be clear on the structure. A PMCF Plan is "higher" in the heirarchy and may call for one or more clinical investigations in order to meet its specified objectives. A Study Plan / CIP / Protocol sets out how an individual study under this umbrella will be performed. Hope that helps?
 
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