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Update Technical File for EU Class IIa Medical Software Products
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Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
Update Technical File for EU Class IIa Medical Software Products
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  Post Number #1  
Old 20th April 2018, 02:58 PM
joy.jian's Avatar
joy.jian

 
 
Total Posts: 1
Question Update Technical File for EU Class IIa Medical Software Products

Hello,

During my process of putting together a technical file for an existing product but new software version, I started to doubt myself if I understand the concept of technical file correctly. We make Class IIa medical image processing software.

Here are my questions:
1. For the same software product family but new version, is it necessary to create a brand new stand-alone technical file?
For example, we have technical files for v2.1, v2.2, v3.1 etc, using the same format. Most contents are identical (ISO certificate, essential requirement checklists, intended use, etc.); some files need to be updated periodically (clinical evaluation report, risk management report, etc.); and some files are version-specific (IFUs, DMR, DHF, etc.)

My concern about keeping a non version-specific TF is that v3.1 does not replace v2.1 or v2.2 - they coexist on the market. The problem though is that the software evolves so quick that a new TF is required almost every few months.
2. Is Technical File a living document? Or it only captures information at the time of creation?
Currently we create a TF when the new software version is picked for mass distribution. For instance, no TF was created for v2.3-2.9 since they are maintenance release.
3. When is it necessary to submit a TH for notified body review?
NSAI reviewed our v2.2 TF, and v3.1 is decided to be the next major release accessible by all clients. Should we have NSAI approve our v3.1 TF before distributing it to customers?
Any advice on the proper way of managing software Technical File is greatly appreciated! Thank you for your time.


Regards,
Joy

Last edited by joy.jian; 20th April 2018 at 03:26 PM.

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  Post Number #2  
Old 20th April 2018, 04:11 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,656
Re: Update Technical File for EU Class IIa Medical Software Products

The Technical File is a living document. The documents do not have to reside in the same location. You can create an index that lists or references the documents and their locations. If you identify the version information on the index, then each time you change the version, the index revision level will change. This can all be done according to your document control system.
Thanks to Al Rosen for your informative Post and/or Attachment!
  Post Number #3  
Old 21st April 2018, 11:07 AM
yodon

 
 
Total Posts: 1,123
Re: Update Technical File for EU Class IIa Medical Software Products

Mr. Rosen's feedback is spot on but you included another question that probably warrants additional discussion.

Quote:
In Reply to Parent Post by joy.jian View Post

NSAI reviewed our v2.2 TF, and v3.1 is decided to be the next major release accessible by all clients. Should we have NSAI approve our v3.1 TF before distributing it to customers?
This is a tricky question and the answer depends on the changes. Did the changes impact the indications for use? Did the changes impact the risk assessment?

I don't know if a full Technical File review would be required but I believe you're expected to at least inform the NB about the changes - especially if they are "significant."
Thanks to yodon for your informative Post and/or Attachment!
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