How to Produce a Technical Fle - EC Marking Guidance Needed - MDD 93/42/EEC directive

P

Pecks

#1
I am in the process of applying for EC Mark certification. I have read the MDD 93/42/EEC directive and have read the EU's so called Blue Book (Guide to implementation. I am still unclear of how to produce a technical file and what the proper steps and format should be for a risk analysis. :confused:

A sample technical file for medical devices and any kind of guidance material for a risk analysis would be greatly appreciated.

Thank you in advance, :thanx:

Pecks
 
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Al Rosen

Staff member
Super Moderator
#2
Pecks said:
I am in the process of applying for EC Mark certification. I have read the MDD 93/42/EEC directive and have read the EU's so called Blue Book (Guide to implementation. I am still unclear of how to produce a technical file and what the proper steps and format should be for a risk analysis. :confused:

A sample technical file for medical devices and any kind of guidance material for a risk analysis would be greatly appreciated.

Thank you in advance, :thanx:

Pecks
There are files in the cove you can use. Do a search in the attachments for *tech* and *risk*. You will find some useful information. For starters see Introduction to risk analysis MD and tech file index.
 
P

Pecks

#3
Need Tech File Sample

Thanks for your time Al. Your help is greatly appreciated and has me headed in the right direction at least.

I would still like to take a look at an actual medical device technical file if anyone has one they wouldn't mind sharing.

Cheers,

Pecks
 

Al Rosen

Staff member
Super Moderator
#4
Pecks said:
Thanks for your time Al. Your help is greatly appreciated and has me headed in the right direction at least.

I would still like to take a look at an actual medical device technical file if anyone has one they wouldn't mind sharing.

Cheers,

Pecks
Much of a Technical File is considered proprietary and the TF can be quite extensive. Don't expect anyone to share it with you.
 
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