Required Frequency of Notified Body reviews of Technical Files

JoCam

JoCam

Trusted Information Resource
Hi All,

What is the required frequency of Notified Body reviews of Technical Files for class IIa, IIb and III medical devices, and where is this stipulated?

I recently read a document that states that it is a legal requirement to have Technical Files reviewed every 2 years. I've always been under the impression that a randomly selected Technical File is reviewed by the Notified Body during each annual surveillance audit, as a way of ensuring compliance with both ISO 9001 and ISO 13485 clauses 5.1(a) and 5.3(b), and then again somewhere within the 3 year unannounced audit period. Have I overlooked something?

Thank you in advance for your help.

Jo
 
N

nozzle

Involved In Discussions
Re: On-going review of Technical Files

Hi Jo
I'm fairly new to technical files myself. Based on my limited experience the notified body will audit technical files at random against 93/42/EEC or 98/79/EC.
Hope that helps.
 
M

MikeKilkelly

Starting to get Involved
Hi Karen, I know your post was some time ago regarding
"What is the required frequency of Notified Body reviews of Technical Files for class IIa, IIb and III medical devices, and where is this stipulated? "

your response "hey have a formula based on the number and class of your devices. Please see NBOG 2009-4. "

I have looked at that document and cannot see how often they review the technical file (I'm interested for a Class IIa device"
 
M

MikeKilkelly

Starting to get Involved
Yes and thanks for pointing it out

".........For each certification period, and at least every 3 years, the NB should identify the technical documentations to be reviewed... "
 
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