Sampling Technical Files Continually throughout the Certification Cycle

somashekar

Staff member
Super Moderator
#1
Hello all CE certified friends...
With the 2012 started, many of you will be up with your MDD assessment plans with your NB for the continued CE certification.
Here find the process for sampling of Technical Files to be done by your NB in accordance with the European Council Directive on Medical Devices.
The Technical File for every device is and should be a living document that is continually updated with information from various sources, such as new or amended harmonized standards, post market surveillance from risk management, customer complaints, design changes, clinical experience and new clinical evidence and the general acknowledged state-of-the-art.
Happy CE.
 

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SteveK

#2
Hi Soma,

As you indicate TFs are living documents – I keep mine (all 13, soon to be 14) up to date in the areas you indicate (also, I was aware of the NBOG document). I have raised this in another post, but apart from one TF I submitted (that I requested that they review because of a ‘substantial’ product change) my NB has never requested any other submissions of my TFs – ever! They did give me a sampling plan in 2010 but have never kept to it. I suspect that along with other NBs they do not have the personnel/expertise/time to review what must be 10s (if not 100s) of thousands of TFs out there.

Steve
 

pkost

Trusted Information Resource
#3
I've posted in the other thread. An update since then....All our technical files have now been reviewed!

edit: our NB's plan seemed to have a lot of flex. I got the impression that many other companies haven't been viewing the files as living documents and were therefore having problems. As a thought (with no evidence)..maybe the less conscientious companies were being prioritised?
 
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pkost

Trusted Information Resource
#5
Thanks for posting that link, it's a very interesting read.

Does the conclusion really justify a change to the directive though? the conclusion is that

a) manufacturers are not producing the information required
b) the NB's are not effective in their reviews.

The directive can certainly be changed to try an remove these issues, but it ignores the root cause of the problem....NB's and manufacturers are not doing what they are already required to do!
 

Marcelo

Inactive Registered Visitor
#6
Does the conclusion really justify a change to the directive though? the conclusion is that

a) manufacturers are not producing the information required
b) the NB's are not effective in their reviews.

The directive can certainly be changed to try an remove these issues, but it ignores the root cause of the problem....NB's and manufacturers are not doing what they are already required to do!
You are right. However, I just mentioned that as a trend....the directives will change for a lot of reasons, in fact, and will include revisions to try and correct these problems.
 

pkost

Trusted Information Resource
#7
You are right. However, I just mentioned that as a trend....the directives will change for a lot of reasons, in fact, and will include revisions to try and correct these problems.
Yes, I agree, it's just a personal hatred of mine when things are rewritten to try to enforce an existing requirement.
 
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