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Understanding The Summary of Technical Documentation

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Understanding The Summary of Technical Documentation

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mntmn4590
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Fact Sheet

Summary of Technical Documentation (STED)


Critical content for compliance with the In Vitro Diagnostics Regulation (IVDR)

What is STED format?

A Summary of Technical Documentation (STED) file is


a detailed description of your IVD Devices’ intended
purpose, demonstration of its performance and
compliance with Harmonized standards. Compiling
your STED is an important part of the EU CE-Mark
process and is required to comply with the In Vitro
Diagnostic Medical Devices Regulation [EU] 2017/746.

Manufacturers of all Classes of IVD medical devices


(Class A, Class B, Class C, and Class D) are expected to
demonstrate conformity of the IVD medical device to
the General Safety and Performance Requirements of
Medical Devices (GSPR) through the preparation and
holding of technical documentation. The STED shows
how each IVD medical device was developed, designed,
verified and validated, and manufactured together
with the descriptions and explanations necessary to
understand the manufacturer’s determination with
respect to such conformity.

STED includes detailed information about the design,


function, composition, use, claims, and clinical studies
and performance evaluation of your IVD medical Why STED format and which regulators
use STED?
device. One STED may be sufficient for multiple
catalogue products if their intended purpose claim,
• The STED format was created by the Global
fundamental technology and Risk class are the same.
Harmonization Task Force (GHTF), the precursor
Claims made by a manufacturer regarding the to the current International Medical Device
performance of a IVD must be supported by objective, Regulators Forum (IMDRF), in an effort to globally
scientific data presented in a structured and logical standardize medical device regulatory submissions
manner. across markets, assisting both manufacturers and
regulatory agencies.
Unless you manufacture a sterile Class A device that
is for sterile purpose, your STED may not be reviewed • STED is recognized by US, European, Canadian,
by a Notified Body (NB) before applying the CE-Mark, Australian and Japanese regulators, as well as in
however a STED still needs to be prepared and updated other markets.
periodically and to demonstrate the compliance with
the regulation.

The higher the risk classification of a IVD, the more


information (and documentation) is to be expected.
Preparation of STED

As a manufacturer, STED documents should be Surveillance (PMS). It should be noted that there are
prepared for your IVD device as per Annex II of many changes and additional details required by the
regulation EU 2017/746, and includes Annex I General IVDR with respect to predecessor In Vitro Diagnostic
Safety and Performance Requirement details and Directive (IVDD) technical file.
Annex III Technical documentation on Post Market

Device
description and
Information
specification,
to be supplied Design and
including
by the manufacturing
variants and
manufacturer information
accessories
software

Summary of technical
Post market
surveillance documentation
activities

Benefit‐risk General
analysis

©2022. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries. 04.2022.MT
Product safety and
verification and risk performance
and validation management requirements
usability

Risk How can IQVIA help you?


classification,
clear intended
purpose IQVIA MedTech’s dedicated regulatory team will help
requirement
EUDAMED you in determining your devices’ classification and
PRRC, Traceability
stringent amelioration grouping of products as per the IVDR. We provide
clinical by UDI strategic guidance and implementation for Directive
evidence
to Regulation remediation activities. Dedicated
IVDR regulatory writers can also support STED remediation,
Performance Evaluation Plan (PEP), Report (PER)
Rigorous Strengthened and its components writing services as per EU IVDR
post-market labelling
surveillance requirements- requirements.
details IFU, labels
Stringent
general safety
and
performance
requirement

CONTACT US
iqvia.com/MedTechClinical

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