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Class II Medical Device Technical File Checklist

Q

quest

#11
#11
Sz - Agreed! But the notified body in question (a very well-known one by the way) has actually included this in their guidance on what a technical file should include.
 
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J0anne

J0anne

Joanne
#12
#12
Here's the current NB MED guidelines http://www.team-nb.org/Documents/R2_5_1-5_rev4.pdf

BUT, you should ask your NB what their preferred format is for review.
Most likely it's the above and it will make their review more efficient.

A technical file is a legal requirement, but is not necessarily all contained withn one file.
You must have the contents as defined in the MDD. These can be held in different locations.
It's your choice.
 
P

prft123

#13
#13
Hi Stevek,

So you mind to share with us the Technical Requirement as well?

Thank you and much appreciate.
 
P

prft123

#15
#15
Hi Steve,

Do you mind to share with us the technical requirements inside your technical file?

Thank you and much appreciate.
 
S

SteveK

#16
#16
prft123 said:
Hi Steve,

Do you mind to share with us the technical requirements inside your technical file?

Thank you and much appreciate.
Click to expand...
The technical requirements would also be as per the applied standard(s). For example a Oxygen Concentrator would be required to meet the requirements of ISO 8359:2009, plus other relevant standards such as EN 60601-1. In my case I summarise the results of testing etc in the "Product Dossier" section of the TF. Technical reports/test sheets etc are also included in the TF. All the standards can be included as an extra stand alone section to a TF i.e. 'Standards Applied', especially if a lot of seperate standards are referenced and applied (see attached).

Steve
 

Attachments

I

IVD_RA

#18
#18
Can someone help me to learn how to develop essential requirement checklist?

My company is devloping heamotology analyzer which is required technical file Annex III requirements. I am following STED format for TF but I have lot of confusion for ERC how to develop it from scratch? I do have template for ERC.

Thanks for help,
Esha
 
S

SteveK

#19
#19
IVD_RA said:
Can someone help me to learn how to develop essential requirement checklist?

My company is devloping heamotology analyzer which is required technical file Annex III requirements. I am following STED format for TF but I have lot of confusion for ERC how to develop it from scratch? I do have template for ERC.

Thanks for help,
Esha
Click to expand...
Although the attached example is obviously not a similar medical device, it should give an idea on how I format an ER. (Note: I've posted a number of TF sections for this item already, so here's another in the family!).

I hope this helps.

Steve
 

Attachments

R

redknight07

#20
#20
SteveK said:
Although the attached example is obviously not a similar medical device, it should give an idea on how I format an ER. (Note: I've posted a number of TF sections for this item already, so here's another in the family!).

I hope this helps.

Steve
Click to expand...
Hi Steve,

In the essential requirements checklist that you've uploaded, it states on the very first page that "Certified by Notified Body to ISO 9001:2008 & ISO 13485:2012. Compliance to BS EN ISO 8185:2009."

Was this checklist revised after you received 13485 certification?! I thought that the certification is granted after the Notified Body has reviewed the design dossier and/or technical file if for a high risk device.

Also for the format of the technical file, you've used the one which presents data in two parts. Of course it has it's advantages but is there any downside if a single format is used to compile the design dossier instead of it being in two parts viz. Part A and Part B. I'm currently compiling a technical file for an Annex II List A IVD.

Just noticed that you're from Manchester, hope it is from the red half of it.

This thread has been an incredible source of information, thank you to everyone who is a regular here, I'm trying as well and hopefully will start contributing soon. :applause:

Any advice is most welcome.

Thanks,
Aniket
 
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