PMCF (Post Market Clinical Followup)/ PSUR template

MDRexpert

Involved In Discussions
#1
Hello All,

All our current product do not require a PMCF, so we are creating a PMCF checklist to justify it.
One of the PSUR requirements is to report the main findings of the PMCF. If we don't need PMCF for our device then how do we add it's main findings?

Please advise. Thanks!
 
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Marcelo

Inactive Registered Visitor
#3
PMCF = Post Market clinical followup
PSUR = ???
PSUR = Periodic Safety Update Report


Hello All,

All our current product do not require a PMCF, so we are creating a PMCF checklist to justify it.
One of the PSUR requirements is to report the main findings of the PMCF. If we don't need PMCF for our device then how do we add it's main findings?

Please advise. Thanks!
PMCF is an ongoing process, a continuous process that updates the clinical evaluation, and is always applicable tom all devices. You probably is saying that a PMCF study (which is one of the tools used in the PMS process) is not applicable to your device. So you will always have PMCF findings to report in the PSUR.
 

lisasolo

Starting to get Involved
#7
Section 6.1 of Annex II on Tech Documentation says to include "the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable."
In Annex III on the PMS plan, it also says to include "a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable."
These seem to imply that it is possible for PMCF to not be applicable. However, there are also many other places in the MDR that says that you shall perform PMCF, implying that it is required. Does anyone know if it is still appropriate to justify PMCF as not applicable under the MDR?
 

Marcelo

Inactive Registered Visitor
#8
There seems to be a inconsistency in the PMCF requirements, but to the this seems to stem from the confusion between PMCF and PMCF study, as I mentioned above.

So, although some parts of the MDR does mention "justification why a PMCF is not applicable", if you read the PMCF "definition"on Annex IV is says:

PART B
POST-MARKET CLINICAL FOLLOW-UP
5. PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan.
As clinical evaluation is required to all devices, PMS shall also be required. This whole annex is very clear on this.
 

Highground

Involved In Discussions
#9
Does that mean we have to have a procedure in place for PMCF? What if we just create a checklist that we can use to justify that we do not require PMCF study?
This is a form we are providing to justify why no PMCF study is required. Of course, there should be more information added to the form.
 

Attachments

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A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
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R Auditing COT's Suppliers / First Post Supplier Quality Assurance and other Supplier Issues 2
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