MEDDEV guideline on Post Market Surveillance (PMS)

N

novemberbirthed

#1
Hello,

Based on MEDDEV 2.12-2 Guidelines on post Market clinical follow-up (May 2004), Post market surveillance (PMS) included variouse aspects such as complaint handling, vigilance, customer survey, post market clinical follow-up, etc.
In the recent revision (MEDDEV 2.12/2 rev2) published on January 2012, post-market clinical follow-up STUDIES have been explained, which will be used to update the clinical evaluation report periodically without any mentioning of customer feedback, etc.

1. Is there any other guideline that currently explains the PMS plan strategies/procedures?
2. Does it mean that clinical evaluaion report alone is enough to adress post market surveillance reporting, or a post market serveillance reprt is separetely needed? It seems to me that they both cover the same thing..
 
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Y

yana prus

#2
1. Is there any other guideline that currently explains the PMS plan strategies/procedures?
http://www.meddev.info/_documents/R2_12-1_rev11.pdf
2. Does it mean that clinical evaluaion report alone is enough to adress post market surveillance reporting, or a post market serveillance reprt is separetely needed? It seems to me that they both cover the same thing..
Clinical Evaluation report is part of PMS, and separate PMS report is needed. The purpose of them is different: a manufacturer?s postmarket surveillance system is often, but not exclusively, the source of information on vigilance and risk assessment according to Vigilance MEDDEV, while the purpose of the clinical evaluation in the post marketing stage according to MEDDEV 2.7.1 is "periodically review performance, safety and the benefitrisk assessment for the device through a clinical evaluation, and update the clinical evidence accordingly. This ongoing clinical evaluation process should allow manufacturers to communicate with conformity assessment bodies and Regulatory Authorities in accordance with local reporting requirements, any information that has an important bearing on the benefit-risk assessment of the device or that would indicate a need for labelling changes regarding contraindications, warnings, precautions or instructions for use etc."
 
N

novemberbirthed

#3
Thank you Yana.
As you mentioned, based on MEDDEV 2.7.1, you need a clinical evaluation report that has to be updated on regular basis based on clinical post-market studies, and outcomes of PMS (or so called clinical experience). This has to be a "stand alone" document.

On the other hand based on 2.12, you need a PMS report that includes clinical evaluation..

It just seems to me redundant to have both documents as their contents are more or less similar (?). Don't you think?
 
R

red66climb

#4
If you read through the 2012 guidance on PMCF Studies you will realize that these studies resemble more formal retrospective clinical studies to address long-term follow-up and usability by larger user populations. PMS is much broader in scope. The PMS plan is already required in a Dossier, but PMCF protocols and reports are anticipated new requirements in the recast regs. BSI published a white paper on PMCF but it will be more important to see how Annex X1.1c is manifested in the new articles and annexes. High risk products might be subject to more specific requirements.
 
C

CBAL08

#5
There are terms like

Post production clinical follow up
Post market clinical follow up
Post market surveillence

I am finding it really difficult to understand all these terms and the process to have in place ( Standrad Procedure).

Is it that Post marketing surveillance is conducted 2 time/ or say one time a year taking into account all complaints, feedbacks from users, experts,services and evaluated. Then the evaluation is fed to Risk managemnet process???

Would really appreciate your help in making me undersatnd all these. Plus would really appreciate if there were example/ sample of these reports and Procedures.
 
E

edgar123

#6
Rather than "Post production clinical follow up" which I think is only present in the GHTF documentation the directive refers to "post-production phase" during which experience gained from devices must be collected.
This concept of post-production phase includes both PMS and PMCF.

That considered, you would have to conduct the following:
- Perform the PMS on a regular basis (complaints, AER, CAPA, impact on risk management). This is done case by case and through trending.
- Perform the PCMF as per plan (say once a year).

The PCMF would not only take clinical data updates into account but also PMS report as an input. That way a decision can be taken based on both inputs regarding the suitability of the product in comparison with the state of the art.

Hoping this helps a bit...
 
C

CBAL08

#7
Thank you for the clarification. However does this Post Market( Production) clinical follow up be done annually for each devices?
Or should it be a part of Post Marketing Surveillence ( Annually)
STill confused.

As such we do look at the complaints, Non conformities.....and update Risk management however do not have a formal way of doing this PMCF ( PPCF?)
 
E

edgar123

#8
The PMCF would be addressing each category of device depending on the clinical application claimed, and once a year is usually sufficient considering the evolutions of the clinical applications.

Even though complaints are analyzed and risk management updated if required continuously, the occurrence has to be re-assessed for instance based on trending. Hence the annual PMS.
Then the PMCF takes it into account from the clinical specialist point of view (suitability of the intended use, user documentation...).

I guess the frequency of both PMS and PMCF has to be assessed based on the benefit-risk ratio and residual risk, and I don't see why both could not be conducted at the same time provided that there is a clear distinction between them.

My 2 cents on a Friday evening
 
C

CBAL08

#9
Anyone to help me with what PMCF plan looks like? Main points that the PMCF plan should have. Same thing with PMS plan. The more I read the more it gtes confused as all the things are leading to one thing how to get feedback on use/ safety of product and how is it fed through the system . How is risk analysis updated by these reports and so on. Need some guidlines from gurus on how can we do it the best and simple way for low risk devices.
 
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