MDR and Summary Technical Documentation Files

Gamula

Involved In Discussions
#11
I am alone AND there are contradictions wihtin e. g. clinical investigation reports or standards to be used (China uses their and slightly different standards or old ISOs; Japan has their own UNIVERSE of standards; USA UDI differs from others like Turkey; etc.). I was all alone doing this, I am on the cutting edge of knowledge at the moment.
 
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RobertvanBoxtel

Involved In Discussions
#12
Dear Original discussion poser:

If your technical documentation has been set-up conform the GHTF document published some years ago, I recommend you put that GHTF document side by side with Annex II of the MDR.
You will be pleasantly surprised by the ~90% equivalence in text. Or should I say copy paste from GHTF to MDR. As it is most of the times even the same.
 

KMac

Registered
#13
Hi All -

Has the EU posted their proposed Classification Matrices to describe the relevant elements of these IMDRF ToCs, as applied to 2017/745 MDR Technical Documentation requirements?

FDA has posted their Classification Matrices in November 2017.

Thanks!
:thanx:
Hi coastalcg I'm just following up on whether you've found the EU's Cllassification Matrices? I've been looking everywhere all day and the closest i can find is a terribly formatted pdf that was from 2015

Thanks
 
#14
Hi everyone.

I'm currently compiling the technical documentation for submission to BSI.

This is my first time compiling a dossier as I have recently started a new role in regulatory affairs.

Looking to get some high level guidance with regards to the cover letter that is required to be submitted with the technical documentation. If anyone could offer me some advice as to what is required/what level of detail is required in the cover letter, it would be much appreciated.
 

Kuldeep Singh

Involved In Discussions
#15
Hello ,

Can anyone help me for my below question

We are planning to prepare a technical documentation as per Annex II, for one of our product classified as Class IIb Rule 10 of EU MDR. We have different model in same device group . Let say A80, A65, A50 , A40 & A15. Is it necessary to provide all the product detail in each section of lower variants such as A65~ A15 . for example, providing the user manual of all the lower variants in Technical documentation , although all the technical details provided in Device description section for these models. A80 model is the highest model and contains all the features of its lower variants.

Providing the technical documentation of A80 model is not sufficient .
 

Asia78

Involved In Discussions
#17
Hello ,

Can anyone help me for my below question

We are planning to prepare a technical documentation as per Annex II, for one of our product classified as Class IIb Rule 10 of EU MDR. We have different model in same device group . Let say A80, A65, A50 , A40 & A15. Is it necessary to provide all the product detail in each section of lower variants such as A65~ A15 . for example, providing the user manual of all the lower variants in Technical documentation , although all the technical details provided in Device description section for these models. A80 model is the highest model and contains all the features of its lower variants.

Providing the technical documentation of A80 model is not sufficient .
Hi,
No, it is not necessary to send to the nb all variants, the nb can and will assess one device, one variant. The assessment of one device with a specific cnd code will "cover" all the other devices same class same cnd code.
This is what we discussed and did with multiple td assessment (nb= tüv Süd).
Hope this helps
 
#18
Is it save to assume that this structure will become the new structure for the technical documentation expected by NBs and would it be a good idea to start structuring our technical documentation according to this document?
I think the IMDRF ToC that was published in 2019 is cumbersome and likely to change, it doesn't seem to align well with the MDR for NB review. Personally, ANNEX II & III directly from the MDR is how I structure the STED.
 
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