'Post market surveillance' versus 'Post Market Clinical Follow Up'

C

CBAL08

#11
Anyone has an example of (PMS tracking schedule and log ).....have database for complaints/ services/ customer feedbacks/bug lists/ ideas on enhancements / however how do we make a schedule where we say when do we look into trends ( monthly/ quaterly/ 6 monthly ) and feed it to the PMS report ( which is yearly??) . Would be really great to get suggestions on how we do the PMS process and in clarifying this issue is highly appreciated.
 
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D

dblnkl

#12
Seems to me that the original question still has not been answered. What is the difference between PMS and PMCF? We know what PMS is; we know what a PMCF study is. So what is PMCF (without the word "study" after it.) There seems to be no definition in the regs. Might I propose a definition?
PMCF could be a general term that describes all kinds of post-market clinical evaluation, like both surveillance and studies of any kind. But that is confusing since PMCF is a term that only appears in the context of PMCF study, whereas PMS is distinctly different. Proposal: PMCF and PMCF study are synonymous. Any thoughts?
 

tehuff

Involved In Discussions
#13
PMCF is a subset of PMS (it's one of the activities that supports PMS). The clinical studies (and registries) that are used to support PMCF would be PMCF studies. See the guidance referenced earlier in this thread -
 
L

Leonard.Lv

#15
Using google, I found an interesting link to BSI. I think this file maybe kind of helpful.
But now I couldn't post that weblink..
 
L

lili69361

#16
I think that they are related two parts. Post market clinical follow up from Clinical site. Post market surveillance should be all collection data from both clinical and non-clinical.
 
T

Tatian

#17
My opinion...

PMCF (post market clinical follow up) is all clinical evidence from actual and similar device such as literature publication on safety and performance as well as use and adverse events reports that should be gathered as part of PMS for all medical devices in a periodically basis.

PMCF study is a clinical investigation for a specific question that remains after initial clinical evaluation and risk analysis that can be carried out after conformity assessment. Not always necessary.

Can anyone tell how NB are taking the absence of PMCF studies for a product with a clinical evaluation based on literature review and clinical experience?
 

Ronen E

Problem Solver
Staff member
Moderator
#18
Re: Post market surveillance

The post-market follow up must be performed to continually confirm that the results you obtained in the initial clinical evaluation are still valid.
The MDD Annex X only mandates that the clinical evaluation documentation be actively updated. The post-market follow up (whatever it means) should be included in the post-market surveillance plan by default, however it may be excluded as long as it's duly justified on record:

1.1c The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
MEDDEV 2.7.1 rev 3 (CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES) doesn't add much clarity on post-market follow up. It only states that the NB should "verify and decide whether or not the manufacturer has adequately justified and documented if post-market clinical follow-up is not planned as part of the post-market surveillance plan" (s. 10.1.1). In terms of requirements from the manufacturer, this is just a replication of the Annex X text.
 

Marcelo

Inactive Registered Visitor
#19
MEDDEV 2.7.1 rev 3 (CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES) doesn't add much clarity on post-market follow up. It only states that the NB should "verify and decide whether or not the manufacturer has adequately justified and documented if post-market clinical follow-up is not planned as part of the post-market surveillance plan" (s. 10.1.1). In terms of requirements from the manufacturer, this is just a replication of the Annex X text.
Have you tried MEDDEV 2.12/2 rev.2 - Post Market Clinical Follow-up studies?
 
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