Clinical Evaluation Plan vs. PMCF Plan

[katezhang]

insightful and helpful!
but for high risk medical device especially those implantable, dose that mean the PMCF be must?
even i didint find any risks exceed current RMM or from PMS data?
p.s. may I ask if you have any approach to do risk benifit ratio?

 

[DamienL]

I've tried to capture this in the attached visio diagram. Would GREATLY appreciate any feedback, corrections, etc.

Hi all, I think this was a great thread, really helpful for getting my head around this stuff.

I've tried to build on Yodon's Visio from earlier with an interaction diagram of my own and thought it might be helpful to post it here. It's quite busy but if you've any suggestions for improvements/corrections please PM me and I will re-post.

Damien

 

[SME4FDA]

Hello,
Do you have an updated procedure on PMCF?

 

[SME4FDA]

Hi all, I think this was a great thread, really helpful for getting my head around this stuff.

I've tried to build on Yodon's Visio from earlier with an interaction diagram of my own and thought it might be helpful to post it here. It's quite busy but if you've any suggestions for improvements/corrections please PM me and I will re-post.

Damien

Do you have an updated procedure on PMCF?

 

[DamienL]

Do you have an updated procedure on PMCF?

Sorry, just this diagram.

 

[Weeder]

The regulations require the creation of several plans like PMS Plan, PMCF Plan, Risk management Plan and Clinical Evaluation plan. Should these plan be free standing documents or should they be incorporated in the respective SOPs? Perhaps they should be in the main Quality Manual?

What does it mean that these plan are part of the Technical Documentation? To me if the PMS process or system is part of the TD than automatically everything connected with it is part of the TD. Why are these called out specifically?

 

[Philip B]

I think the PMS plan is specifically called out because PMS is a regulatory requirement and your technical documentation needs to demonstrate compliance. Some things eg an internal audit plan, aren't a specific regulatory requirement and aren't called out in the regs but are implied of course by the requirement to have a QMS.
I think you can have the plan in any format you want as long as you demonstrate that you are planning the activity. We have stand alone plans, referred to in a procedure.

 

[DamienL]

Agree that you could have the plans in any format, however may be beneficial in certains cases to have stand-alone plans where you could get into product-specific planning detail. Not sure how you'd do that with a product-generic plan like an SOP.

 

[Raisin picker]

I think Damien has the right idea: The plans (PMS, PMCF, CEP, less so RM) need to be product specific. And, these plans need to change more or less regularly (you are planning a new PMS activity in one year, but next year it is not needed anymore).
Your SOP can hopefully stay the same for some time.

 

[Weeder]

Thanks everyone for the feedback,

I agree it makes more sense to have the plan as a separate document that can be updated independently of the SOP. I think I was overthinking the process and complicating it. This forum is really helpful in sorting things out. I appreciate the input everyone provides.