HeatherC-S

Starting to get Involved
#1
Hello

I am CE marking a low risk self declared IVD and was advised to follow the STED format for the technical file outlined by the GHTF. However, this body has now been replaced by the IMDRF and am trying to find an alternative for the STED format or can I use the already existing one? As all of the documentation is recommendations only and not a requirement, I am confused as what to use. Any advice please? Thanks
 

Ronen E

Just a person
Super Moderator
#2
Re: GHTF AND IMDRF

In my opinion there's no issue with continuing to use the GHTF's STED format even though the GHTF has ceased operating.
Further, I would suggest you consult the IVDD and get a first-hand impression of what it actually requires. It's not too long.
Further more, the new IVDR has been recently adopted by the EU parliament, is expected to be officially published in the OJ in May and will come into effect 20 days later. There is a 5 years transition period however you should be aware that there will be no more self-certification for IVD devices once the IVD directive is repealed (2022). All IVD devices will need to be NB certified by the due date.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
I also don't see a problem in using the GHTF STED format right now, but keep in mind that it's being transitioned to the IMDRF TOC (and in fact the TOC is better in the way of managing and structuring information, in my opinion).
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#6
Oh, it's not an "official" transition because the GHTF STED format was never formally required, and the TOC is part of the RPS program which is still in pilot. But in the future, it's expected that at least IMDR members use the TOC as basis for requiring information for regulatory submissions. For example, Brazil already requires part of the IMFRF TOC for technical documentation of some device lasses.
 

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