EXPERIMENT: DATE:

STED APPLICATION FOR CLASS III DEVICES

AIM: To prepare and submit the STED application for class III devices.
REFERENCE:

1.GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity

to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
- 17 March 2011https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg1/technical-
docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-
110317.pdf

INTRODUCTION:
The Global Harmonization Task Force (GHTF) aims to standardize the documentation proving
conformity with Essential Principles of safety and performance for IVD medical devices. The
Summary Technical Documentation (STED) serves as this evidence, providing regulatory
bodies with a uniform set of documents. This harmonized approach helps manufacturers reduce
costs, streamline regulatory reviews, and expedite international market access. The STED file
outlines the device’s intended purpose, design, performance, compliance with standards, and
evaluation data. One STED can cover multiple products if their purpose, technology, and risk
classification are the same.

Rationale
Manufacturers must maintain technical documentation showing the development, design, and
manufacturing of each IVD medical device, typically managed within their quality
management system (QMS). For regulatory assessments, a summarized subset of this
documentation is used for premarket and post-market conformity evaluations. This abridged
set provides sufficient detail for regulatory authorities or conformity assessment bodies to
ensure the device meets the Essential Principles of Safety and Performance while streamlining
the review process.

Purpose
This document is intended to provide guidance on the content of the STED for IVD medical
devices to be assembled and submitted, where applicable, to a RA or CAB for premarket
review, and for use post-market to assess continuing conformity to the Essential Principles.

Scope
This document applies to all products that fall within the definition of an IVD medical device
that appears within the GHTF document Principles of In Vitro Diagnostic Medical Devices
Classification.

Technical Documentation definition:

The documented evidence, normally an output of the quality management system, which
demonstrates conformity of a device to the Essential Principles of Safety and Performance of
Medical Devices.

STED application consists of 2 parts

 Part 1 – purpose of the STED
 Part 2 – contents of the STED

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PART 1 – PURPOSE OF THE STED
Preparation:
To conformity assessment, the manufacturer assembles the STED from existing technical
documentation to provide evidence to the RA/CAB that the subject IVD medical device is in
conformity with the Essential Principles. The STED reflects the status of the IVD medical
device at a particular moment in time (e.g. at the moment of premarket submission or when
requested by a RA for post market purposes) and is prepared in order to meet regulatory
requirements.

The Use of the STED in the Premarket Phase:

In the premarket phase, the STED will be prepared and submitted to the RA/CAB for Class C
and D IVD medical devices. For Class A and B IVD medical devices, the STED will be
prepared and submitted only at the request of a RA/CAB7 .In this case, the manufacturer should
be able to assemble and submit it in the timeframe indicated by the RA/CAB. The content of
any submitted STED should be traceable by the manufacturer for future reference.

The Use of the STED in the Post-market Phase:

In the post-market phase, the RA/CAB may request submission of a STED to investigate the
continued conformity for any Class of IVD medical device.The STED would not typically be
used to aid the post-market investigation of adverse events, or the reporting of data from post-
market registries or studies, where different types of information are likely to be called for. If
requested, the manufacturer should be able to prepare and submit the STED in the timeframe
indicated by the RA/CAB. The content of any submitted STED should be traceable by the
manufacturer for future reference.

The Use of the STED to Notify Changes to the RA/CAB:

Where prior approval of a proposed change to an IVD medical device is required, the STED
may be used in support of this process. Guidance on this case will be provided in the future.

MANUFACTURER’STECHNICAL
SUMMARY TECHNICAL
DOCUMENTATION (Controlled DOCUMENTATION (STED)
Documentation subset
Documents e.g. Under a QMS)

Device description and product specification, General description and list ofspecified
including variants andaccessories features

Documentation subset

E.P. Checklist

Proof of conformity to relevant Essential

Principles Upon request, prepare STED for
Class A & B devices & make
Device risk management file Risk analysis and control summary
availablefor review by RA/CAB

Complete design and manufacturinginformation Summary of the technical documentation

concerning designand manufacturing

Complete product verification andvalidation Summary of verification andvalidation

documentation studies

Documentation subset

Clinical evidence Clinical Evidence Evaluation report

Labelling Set of labels and IFU

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 MANUFACTURER’STECHNICAL
SUMMARY TECHNICAL
DOCUMENTATION (STED)
DOCUMENTATION (Controlled Documentation subset
Documents e.g. Under a QMS)
Device description and product specification, General description and list ofspecified
including variants andaccessories features

Documentation subset

E.P. Checklist

Proof of conformity to relevant Essential Upon request, prepare STED for

Device risk management file Class A & B devices & make Risk analysis and control summary
availablefor review by RA/CAB

Complete design and manufacturinginformation Summary of the technical documentation

concerning designand manufacturing

Complete product verification andvalidation Summary of verification andvalidation

documentation studies
Documentation subset

The flow of information from the technical documentation to the STED is illustrated
in Figures 1 and 2. It can be seen from these figures that the content of the STED is
the same for both pre and post market use but the circumstances for the use of the
STED are different. Where the STED is submitted to a RA/CAB, it should be in a
languageacceptable to the reviewing organisation.

The depth and detail of the information contained in the STED will primarilydepend
on the classification of the subject IVD medical device.

PART 2 – CONTENTS OF THE STED

Device Description including Variants (Configurations) and Accessories:
I) Device Description:
The STED should include the following device descriptive information:
a) The intended use of the IVD medical device.
b) The intended user (lay person or professional)
c) A general description of the principle of the assay method or instrument principles of
operation
d) The Class of the device and the applicable classification rule according to Principles of
In Vitro Diagnostic Medical Devices Classification
e) A description of the components (e.g. reagents, assay controls and calibrators) and
where appropriate, a description of the reactive ingredients of relevant components
(such as antibodies, antigens, nucleic acid primers)
f) A description of the specimen collection and transport materials provided with the IVD
medical device or descriptions of specifications recommended for use
g) For instruments of automated assays: a description of the appropriate assay
characteristics or dedicated assays
h) For automated assays: a description of the appropriate instrumentation characteristics
or dedicated instrumentation
i) A description of any software to be used with the IVD medical device
j) A description or complete list of the various configurations/variants of the IVD medical
device that will be made available
k) A description of the accessories, other IVD medical devices and other products that are
not IVD medical devices, which are intended to be used in combination with the IVD
medical device.

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II) Reference to the Manufacturer’s Previous Device Generation(s) and/or Similar
Devices or Device History:
a) For an IVD medical device not yet available on any market
b) For an IVD medical device already available on the market in any jurisdiction
Essential Principles (EP) Checklist:
The STED should include an EP checklist that identifies:
a) The Essential Principles
b) For each Essential Principle whether it applies to the IVD medical device and if not,
why not
c) The method used to demonstrate conformity with each Essential Principle that applies
and
d) The reference to the actual technical documentation that offers evidence of conformity
with each method used.

Risk Analysis and Control Summary:

The STED should contain a summary of the risks identified during the risk analysis process
and a description of how these risks have been controlled to an acceptable level. Preferably,
this risk analysis should be based on recognised standards and be part of the manufacturer’s
risk management plan.
The results of the risk analysis should provide a conclusion with evidence that remaining risks
are acceptable when compared to the benefits.

Design and Manufacturing Information:

Device Design:
The STED should contain information to allow a reviewer to obtain a general understanding
of the design applied to the IVD medical device. It should include a description of the critical
ingredients of an assay such as antibodies, antigens, enzymes and nucleic acid primers provided
or recommended for use with the IVD medical device.
For instruments this would include a description of major subsystems, analytical technology
(e.g. operating principles, control mechanisms), dedicated computer hardware and software.

Manufacturing Processes:
Not required for class III medical devices
Product Verification and Validation:
The STED should summarise the results of verification and validation studies undertaken to
demonstrate conformity of the IVD medical device with the Essential Principles that apply to
it. Where appropriate, such information might come from the literature.
1. Summary Information
A summary should provide enough information to allow the RA/CAB to assess the validity of
that information.
This summary should contain a brief description of:
a) The study protocol,
b) The study results,
c) The study conclusion.
2. Detailed Information
Detailed information should include:
a) The complete study protocol,
b) The method of data analysis,
c) The complete study report,

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 d) The study conclusion.
For detailed information, when a recognized standard exists that contains the protocol and the
method of data analysis, this information can be substituted by a declaration/certificate of
conformity to the recognized standard. However, a summary of the data and conclusions should
be provided.

Analytical Performance:
The statements and descriptions in the following sections refer to all IVD medical devices. It
must be noted however that there are applicability differences between instrumentation and
reagent-based assays, and that the assays themselves may be quantitative, semi-quantitative or
qualitative in nature.
a) Specimen type
This section should describe the different specimen types that can be used. This should include
their stability and storage conditions and is typically applicable to all systems and assay types.
b) Analytical performance characteristics
 Accuracy of measurement
 Trueness of measurement
 Precision of measurement
 Analytical sensitivity
 Analytical specificity
 Metrological traceability of calibrator and control material values
 Measuring range of the assay
Typically for Class C and D IVD medical devices, detailed information would be provided.

Clinical Performance:
Where relevant, the STED should contain data on the clinical performance of the IVD medical
device. This clinical performance data is one of the elements of clinical evidence that
demonstrates the conformity of the IVD medical device to the Essential Principles that apply
to it.

Stability (excluding specimen stability):

This section should describe claimed shelf life, in use stability and shipping studies.

Software Verification and Validation:

The STED should contain evidence of the validation of the software, as used in the finished
device. This information should typically include the summary results of all verification,
validation and testing performed in-house and as applicable in an actual user environment prior
to final release. It should also address all of the different hardware configurations and, where
applicable, operating systems identified in the labelling.

Labelling:
The STED should typically contain a complete set of labelling associated with the IVD medical
device as described in GHTF guideline labelling for Medical Devices.
Information on labelling should include the following:

 Labels on the IVD medical device (immediate and outer container)

 Instructions for use Where the STED is submitted to a RA/CAB, the labelling set should
be in a language required by the reviewing jurisdiction.

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Format of the STED:
While this guidance document makes no specific recommendation for the format of the STED.
Declaration of Conformity:
The Declaration of Conformity is not part of the STED.

REPORT:

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