CE Marking Medical Device and classification

T

topher4209

#1
My company manufactures lead wires and electrodes for monitoring patients. I have been tasked to complete a Technical file for CE Marking. It would be a great help if anyone can help me class my device and maybe provide an example of a Technical file. This product is under the FDA as a class 2 device. Thank you in advance with guidance.
:thanks:
Regards,

Topher4209
 
Last edited by a moderator:
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G

Guillaume Prom

#3
Hi,

classification is defined in directive 93/42/eec , Annex IX.
you can use MedDev 2.4/1 rev9 for more information.

Depending on the application, electrodes can be class I (non invasive) to III (CNS electrodes).
 
T

topher4209

#4
Thank you,

I believe I got in narrowed down to a class 1, non invasive. And thanks for the link for help with the TF. :thanks:
 
T

topher4209

#6
First off Thank you for the Guidence. It was a huge help. I have another question if I may. In my Technical File if a WI, or procedure is referenced in a document, do I have to add that WI, or procedure?
 

Marcelo

Inactive Registered Visitor
#7
In my Technical File if a WI, or procedure is referenced in a document, do I have to add that WI, or procedure?
Add to the Technical File? Usually not, only a reference, and then if someone wants to verify the reference, you get the document (please remember that the technical file is to be maintained mainly as a way to show compliance with the regulation and to facilitate inspections. If it was a design dossier (meaning, you would need to send it prior to inspection to the NB), then some documents would probably need to be incorporated).
 
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