Son of Paperman
Starting to get Involved
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.
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.