CE Mark Technical File - Procedure for the generation of a "Technical File"

highlyexpqe · Feb 1, 2011

I am compiling a CE Technical file for a Medical Device. One of the requirements is that I supply a copy of the procedure for the generation of a "Technical File" Does anybody have a sample of or could give me the format to generate a procedure for the generation of a Technical File? Any help is appreciated.

Al Rosen · Feb 1, 2011

highlyexpqe said:
I am compiling a CE Technical file for a Medical Device. One of the requirements is that I supply a copy of the procedure for the generation of a "Technical File" Does anybody have a sample of or could give me the format to generate a procedure for the generation of a Technical File? Any help is appreciated.

This template, Preparation of a Technical File, may help you.

SteveK · Feb 2, 2011

As well as what Al has directed you to you can also refer to the NB-MED if not already found out there in the ether:

http://www.meddev.info/_documents/R2_5_1-5_rev4.pdf

Steve

kanwal · Feb 5, 2011

The general structure of a Technical File is given in Clause 3 of Annex VII of the MDD 93/42/EC.

Aaria · Jul 12, 2014

I am wondering what provisions do companies have to maintain the technical file by assessing changes? Is there a sample SOP/template?

clafarge · Dec 2, 2014

Is this file still available? The like takes me to a "Not found, error 404" page.
Thanks

CE Mark Technical File - Procedure for the generation of a "Technical File"

highlyexpqe

Al Rosen

SteveK

kanwal

Aaria

clafarge

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