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

Dave-h

Involved In Discussions
#1
Dear All,

In the world of medical devices in Europe, we are all familiar with post market surveillance. but the modified directive and the Notified Bodies are now talking about "Post Market Clinical Follow Up".

Can anyone tell me what "Post Market Clinical Follow Up" actually is, and how if differs from post market surveillance.

In our case, our products are surgical equipment (2a)

Thanks for your help.

Dave
 
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Marcelo

Inactive Registered Visitor
#2
Re: Post market surveillance

Clinical evaluation must be performed, for all devices, as a mean of showing compliance with the performance essential requirements of the medical devices directive (sections 1 and 3). You will need to provide data, be it in the form of a literature review or clinical investigation or both.

The post-market follow up must be performed to continually confirm that the results you obtained in the initial clinical evaluation are still valid.
 
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LievenDW

Involved In Discussions
#3
Re: Post market surveillance

In my opinion it is a follow-up of patients and devices after a clinical investigation. There is a guidance document: MEDDEV 2.12-2 (http :// www. meddev.info/_documents/2_12-2_05-2004.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS)
 
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S

SteveK

#4
Hi Dave,

IMO it is just the source of the data - i.e. Post market surveillance could come from non-clinical type sources e.g. complaint analysis, reordering, marketing etc. Clinical data could come from published literature, references to trials on a particular piece of kit, adverse incidents (e.g. from the MHRA) and so on which might be related to something similar to your own device(s).:2cents:

Steve
 
D

dinda

#5
dear all,
in council directive 93/42/eec, there are two part of technical file, can anyone tell me what "difference of those part" according nb-meb2.5.1

in this case, our product in condom
 

Marcelo

Inactive Registered Visitor
#6
Just noticed that this in the IEC and medical device standards forum...i will move it to the CE Marking forum where it belongs.
 

LievenDW

Involved In Discussions
#7
Hi Dinda, I'm not sure what you exactly mean by 2 technical files, but it might be this: the MDD contains several annexes with (sometimes slight) different requirements. The annexes you must comply with depend on the class of your product (class I, IIa,, IIb or III).
 

Sam Lazzara

Trusted Information Resource
#8
Happy 2012!
With the new year comes an updated guidance for PMCF Studies.
Remember, Post Market Surveillance (PMS) is always required. A PMCF Study is a specific PMS tool that can be applied if warranted.
The updated guidance sheds more light on when PMCF Studies might be appropriate.

Post-market clinical follow-up (PMCF) study: A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling.

It is becoming common for companies to sign up for post-CE marking PMCF Studies as a strategy for gaining Notified Body approval when CE marking is based on equivalence to other devices, without direct clinical investigation data for the subject device.

Link directly to document:
http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf

Link to main page for Europe medical device guidelines:
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
 
#9
dear all,
in council directive 93/42/eec, there are two part of technical file, can anyone tell me what "difference of those part" according nb-meb2.5.1
The recommendation is that Technical Files are prepared in 2 parts - A and B.

Part A is intended as a summary and should contain:
1) Administrative details (manufacturer and notified body address etc)
2) Declaration of Conformity
3) A brief description of the device
4) Labeling (including instructions for use)
5) List of technical standards with which compliance is claimed
6) Brief outline of bench testing performed and clinical data obtained

The idea is that should a national compliance authority need to check on your product (perhaps they have a report of a problem from a hospital) then you can very quickly provide them with part A.

Part B is everything else. So that covers a full description, test reports, risk management report, clinical data, manufacturing details etc etc. It is accepted that it may take a manufacturer a few days to compile a part B (although you would need to compile it anyway for your notified body to review).

For very simple products (class 1) I have seen parts A and B combined into 1 folder.

See here:
http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=17&Itemid=38&lang=en

for revision 4 of the NB Med guidance. Section 4 gives the suggested formatting.
 
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Q

qd6summer

#10
Dear Sam,
Thanks for your explainsion. But I'm still confused with one thing, are PMCF and PMCF studies the same thing? 2.12.2 in 2004 is call Guidence to PMCF, but after that it became PMCF study?
Thank you.
 
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