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IMDRF or still GHTF for STED and other guidance?

#1
Since July of this year I am working for a Dutch company that produces dental- and CMF-implants. Before that I worked for an IVD-manufacturer.
In both companies part of my duties is the registration/notification of the manufactured devices with competent authorities. As a result I now have to start a product-registration procedure suitable for a notification compliant to the EU's MDR.
For my previous work I used the GHTF STED-documenation to set up the registration file. Because I now work on medical devices I went to the IMDRF-site for medical device STED-guidance documentation. There I discovered that IMDRF has documentation, dated March 2019, that seem to be the follow up of the GHTF-STED.
A search for STED only leads to GHTF documents of which the latest STED for medical devices is a proposed document from 5 March 2007. The most current accepted GHTF-version is from 25 October 2002. Are the 2002 GHTF-documents still the current official version or have they become defunct as result of the new IMDRF-documentation, and are the IMDRF-versions now the official version?

It is very confusing to me.

Can someone inform me on:
- what documenation to use, GHTF or IMDRF?
- if IMDRF then which documents?

Thank you very much in advance for your help.
 
#2
Use the IMDRF TOC from the Regulated Product Submission action item in principle. I don't like some of the things the TOC has (for example, including full reports in the body instead of on the Annex), but this will be used I the future. Anyway, I suggest still using the concepts from the GHTF documents too.
 
#3
Thank you very much for the quick response Marcelo.
Combining IMDRF and GHTF makes it difficult, especially since the most recent GHTF-version (SG1(PD)/N011R20) is a proposed revised document, and not a final version. That revised version has far more elements though, and in doing so has much more compatibility to the MDR-requirements.
Which one to use as the main guide document for a registration file, GHTF or IMDRF?

- [SG1/N011R17] GHTF SG1 - Principles of Safety and Performance of Medical Devices (STED) - 25 October 2002:
###.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n011r17-conformity-to-safety-principles-medical-devices-021025.doc
- [SG1(PD)/N011R20] GHTF SG1 Essential Principles of Safety and Performance of Medical Devices (STED) - 5 March 2007:
###.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n011r20-essential-principles-safety-performance-medical-devices-sted.doc
 
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#4
Hu, sorry, I did not suggest formally combining, only using the GHTF docs because the concepts are still the same. In fact, the TOC is an "evolution"of the old STED format.

I also combine different documents which I think give best solutions, for example, in the case of what to write in each topic, I use as a basis the FDA guidance on Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.

It's also very important to include, in each topic, a discussion on why what you did fulfills which specific regulatory requirement you want to show conformity with .

The essential principles to be used really depends on the country-regulatory system you want to apply to.
 
#5
Once again many thanks for the quick response.
I'll discuss your information with my colleague. I'm certain we will return with further questions (and gladly make use of the offer formulated in the red footers of your replies). For now we are going to try to organise the requirements from the various IMDRF/GHTF documents.
 
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