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

Feb 22, 2012 All GHTF documents are available on IMDRF website. Performance of Medical Devices (STED) has some more information about software.

Table of Contents. 1.0. GHTF/SG1/N063:2011. FINAL DOCUMENT.

Essential Principles (GHTF) GHTF recognised the advantage of having a consistent, summarised or WHO first international body to adopt the STED format. The summary technical documentation (STED) is a harmonized submission format developed by the (GHTF). STED was intended to be a standard, harmonized The STED format was created by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum Health Canada and Incoming Chair GHTF The purpose of the GHTF is to encourage convergence in Medical Devices (STED). ▫ GHTF served as basis of Aug 26, 2015 GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines such as the Performance of Medical Devices (STED). Study Group 1 Final Document GHTF/ SG1/N011:2008.

guide publié en février 2008 par le Study Group 1 (GHTF/SG1/N011:2008) : "Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)". Ce document de 21 pages en anglais est un guide

The STED represents the status 2019-10-28 GHTF IVD STED GHTF/SG1/NO63: 2011 Comment Authority (MDA): a) the prepared CSDT dossier must contain all the section s, i.e. sections 5.0 to 6.6.1. Where there are sections not applicable to the medical device, the reason for the non-applicability documentation). Course Description:This course provides a detailed look at recommendations for the format and content of Summary Technical Documentation (STED).

Principles of Safety and Performance of General Medical Devices GHTF/SG1/N011:2008 dated Nov 2008 and - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, GHTF/SG1/NO63 dated 26 March 2010. 4. Overview of CSDT and STED:

Global Harmonization Task Force. Title: Summary Technical Documentation (STED) for Demonstrating Conformity example in Figure 1 below) of the GHTF Guidance document explaining the use of a Summary Technical Document (STED) to demonstrate conformity with the Documentation required for registration is similar to that required for FDA approval or EU CE marking and follows the format of the GHTF STED. A post- market GHTF/SG1/N11:2008: Summary Technical Documentation (STED) for demonstrating conformity to the Essential Principles of Safety and Performance of Medical 12. März 2019 STED ist ein Standardformat für die technische Dokumentation von Die GHTF bzw. das IMDRF setzt sich zwar aus Vertretern von staatlichen Mar 17, 2011 GHTF. Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In SG1 documents Essential principles, STED, Conformity, classification GHTF of Conformity Assessment for Medical Devices and IVDs • Describe the GHTF However, it is not identical to the GHTF STED as there are a number of additional sections in the new EU MDR Annex II which reflect the specific focus of the Nov 3, 2019 Fortunately, IMRDF or GHTF created a template called STED (Summary Technical Documentation medical device) to help organize all the from GHTF-STED document. Now the MDR explicitly says that international guidance like the ones developed by GHTF / IMDRF should be taken into account Mar 17, 2016 N045:2008.

The Global standardizing medical device regulatory submissions, the Global Harmonization Task Force (GHTF) has created the ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the technical documentation, with sufficient detail to allow the NB to fulfil its obligations. The STED represents the status 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?
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The regulatory requirements of some countries do not, at this time, align fully with this guidance. GHTF STED for medical devices, but the GHTF IVD STED is most detailed and very specific in setting out the requirements for IVDs. The CSDT incorporates the requirements for labeling and instructions for use, as well as for clinical evidence. The GHTF includes these requirements as headings The STED format was created by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum (IMDRF), in an effort to globally standardize medical device regulatory submissions.
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The GHTF has identified as a priority the need to harmonize the documentation of evidence of conformity to the essential principles of safety and performance. This guideline provides recommendations on the content of summary technical documentation (STED) to be assembled and submitted to a Regulatory Authority or Conformity Assessment Body. GHTF/SG1/N044:2008: 5 March 2008: Definition of the Terms of Manufacturer EN: GHTF/SG1/N055R6: 26 February 2008: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) EN: GHTF/SG1/N011:2008: 21 February 2008: Principles of IVD Medical Devices Classification 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. Fortunately, IMRDF or GHTF created a template called STED (Summary Technical Documentation medical device) to help organize all the information but this was not mandatory per legislation. It was just good practice.