Technical Guidance Series for WHO

prequalification of in vitro diagnostic

medical devices

Standards applicable to
the WHO Prequalification
of in vitro diagnostic TGS–1
medical devices
© World Health Organization 2017

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Contact: Irena Prat, EMP Prequalification Team Diagnostics

WHO - 20 Avenue Appia - 1211 Geneva 27 Switzerland

 WHO Prequalification Programme: IVD Technical Guidance
Series
WHO The WHO Prequalification Programme is coordinated through the Department of
Prequalification Essential Medicines and Health Products. WHO prequalification of in vitro
of IVDs
diagnostics (IVDs) is intended to promote and facilitate access to safe, appropriate
and affordable IVDs of good quality in an equitable manner. The focus is on IVDs
for priority diseases and their suitability for use in resource-limited settings. The
WHO Prequalification Programme undertakes a comprehensive assessment of
individual IVDs through a standardized procedure that is aligned with
international best regulatory practice. It also undertakes post-qualification
activities for IVDs to ensure their ongoing compliance with prequalification
requirements.
Procurement of Products that are prequalified by WHO are eligible for procurement by United
prequalified Nations agencies. The products are then commonly purchased for use in low- and
IVDs
middle-income countries.
Prequalification IVDs prequalified by WHO are expected to be accurate, reliable and able to
requirements perform as intended for the lifetime of the IVD under conditions likely to be
experienced by a typical user in resource-limited settings. The countries where
WHO-prequalified IVDs are procured often have minimal regulatory requirements,
and the use of IVDs in these countries presents specific challenges. For instance,
IVDs are often used by health-care workers who do not have extensive training in
laboratory techniques, in harsh environmental conditions, in the absence of
extensive pre- and post-test quality assurance capacity, and for patients with a
disease profile that differs from the profiles encountered in high-income countries.
Therefore, the requirements of the WHO Prequalification Programme may differ
from the requirements of high-income countries, or those of the regulatory
authority in the country of manufacture.
About the The Technical Guidance Series (TGS) was developed following a consultation held
Technical on 10–13 March 2015 in Geneva, Switzerland. The consultation was attended by
Guidance
Series
experts from national regulatory authorities, national reference laboratories and
WHO prequalification dossier reviewers and inspectors. The guidance series is a
result of the efforts of this and other international working groups.
Audience and This guidance is intended for manufacturers interested in WHO prequalification of
scope their IVD. It applies in principle to all IVDs that are eligible for WHO
prequalification for use in WHO Member States. This guidance should be read in
conjunction with relevant international and national standards and guidance.
The TGS guidance documents are freely available on the WHO website.
Contents
Acknowledgements.......................................................................... 2

1 Abbreviations ......................................................................... 3

2 Definitions ............................................................................. 4

3 Introduction ........................................................................... 5
3.1 Key concepts ...............................................................5
3.2 Purpose of this document ...........................................5

4 Use of standards..................................................................... 6
4.1 General principles .......................................................6
4.2 Alternatives to international standards ......................6
4.3 Use of standards by manufacturers ............................6

5 Tables of standards ................................................................ 8

5.1 Vocabulary...................................................................8
5.2 IVD design....................................................................9
5.3 Risk ............................................................................10
5.4 Manufacturing ...........................................................11
5.5 Quality systems .........................................................12
5.6 Pre-market evaluation...............................................14
5.7 Analytical performance .............................................15
5.8 Specimen collection and transport ...........................18
5.9 Stability ......................................................................19
5.10 Self-testing considerations ........................................20
5.11 Flex studies (Robustness) ..........................................20
5.12 Clinical performance .................................................20
5.13 Labelling ....................................................................22
5.14 Software ....................................................................24
5.15 Post Market Surveillance...........................................25
5.16 Changes .....................................................................27

6 Websites with additional information ................................... 28

7 References ........................................................................... 30
 Technical Guidance Series for WHO prequalification – Diagnostic assessment:
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Acknowledgements
The document TGS-1 Standards applicable to the WHO prequalification of in vitro
diagnostics was developed was developed with support from the Bill & Melinda Gates
Foundation and UNITAID. The first draft was prepared in collaboration with Dr Elliot Cowan,
Washington DC, USA and subsequent drafts by Deirdre Healy, WHO. This document was
produced under the coordination and supervision of Deirdre Healy, Robyn Meurant and Irena
Prat, Prequalification team – Diagnostic Assessment, WHO, Geneva, Switzerland.

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1 Abbreviations

21 CFR Title 21 of the US Code of Federal Regulations

AHWP Asian Harmonization Working Party

ANSI/ASQ/CEN American National Standards Institute /American Society

for Quality/European Committee for Standardization

ANSI/AAMI/IEC American National Standards Institute/Association for

the Advancement of Medical
Instrumentation/International Electrotechnical
Commission

ASTM ASTM International

CEN European Committee for Standardization

Cenelec European Committee for Electrotechnical

Standardization

CLSI Clinical and Laboratory Standards Institute

FDA US Food and Drug Administration

FIND Foundation for Innovative New Diagnostics

GHTF Global Harmonization Task Force

ICH International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use
IEC International Electrotechnical Commission
IMDRF International Medical Device Regulators Forum
ISO International Organization for Standardization
IVD In vitro diagnostic medical device
TDR Special Programme for Research and Training in Tropical
Diseases
TGA Australian Government Department of Health
Therapeutic Goods Administration
USP United States Pharmacopeia
WHO / FIND / TDR / World Health Organization/ Foundation for Innovative
Roll Back Malaria New Diagnostics/ Special Programme for Research and
Training in Tropical Diseases/Roll Back Malaria
Partnership

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2 Definitions
The definitions given below apply to the terms used in this document. They may have different
meaning in other contexts.

Essential Principles of Safety and Performance (“Essential Principles”): The fundamental design and
manufacturing principles relating to an in vitro diagnostic.
Source: (1)

In vitro diagnostic (IVD)medical device: A medical device, whether used alone or in combination,
intended by the manufacturer for the in vitro examination of specimens derived
from the human body solely or principally to provide information for diagnostic,
monitoring or compatibility purposes.
NOTE 1: IVDs include reagents, calibrators, control materials, specimen
receptacles, software, and related instruments or apparatus or other articles and
are used, for example, for the following test purposes: diagnosis, aid to diagnosis,
screening, monitoring, predisposition, prognosis, prediction, determination of
physiological status.
Source: (2)

Standard: A document, established by consensus and approved by a recognized body, that

provides, for common and repeated use, rules, guidelines or characteristics for
activities or their results, aimed at the achievement of the optimum degree of
order in a given context.
NOTE 1: Standards should be based on the consolidated results of science,
technology and experience, and aimed at the promotion of optimum community
benefits.
Source: (3)
NOTE 2: Standards include such guidance documents as standards, codes,
specifications, handbooks and guidelines. This term is not to be mistaken as
referring to a sample for calibration or control.
Recognized standard: Standard deemed to offer the presumption of conformity
to specific Essential Principles of Safety and Performance.
Source: (3)

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3 Introduction
3.1 Key concepts
This document identifies standards and guidance that contains valuable information on a
range of issues that are encountered in the manufacture, verification, and validation of in
vitro diagnostics medical devices (IVDs). This document should not be taken as a prescriptive
checklist of all references, but those identified are most widely applicable to the IVDs that
are assessed for WHO prequalification. The tables reference international standards, global1,
national, and regional and industry standards and regulatory authority guidelines. The tables
will be updated as more standards and guidance are published, updated or superseded. In
addition, there are links to useful websites from standards organizations and mature
regulatory authorities that reference additional standards and guidance documents to
consider.

3.2 Purpose of this document

The purpose of this document is to:
 provide IVD manufacturers and regulators of IVDs with references to standards
and guidance that are applicable to IVDs ; and
 encourage manufacturers to use appropriate international standards when
demonstrating the IVD conforms to relevant essential safety and performance
principles.

1
Standards that, while not being international standards, have gained acceptance in many parts of the world.

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4 Use of standards
4.1 General principles
International guidance and standards specify in detail how regulatory compliance with the
Essential Principles of Safety and Performance for in vitro diagnostics (IVDs) can be achieved.
They are building blocks for harmonized regulatory processes to assure the safety, quality
and performance of IVDs. They represent the opinion of experts from all interested parties,
including industry, regulators, users and others. International standards should thus be used
by the manufacturers to assure the safety, quality and performance of medical devices and
should be recognized by regulatory authorities as a means to harmonize regulatory processes.
WHO Prequalification – Diagnostic Assessment team follows internationally recognized
practices in its assessment of a product, and has a focus on identifying if a product for
prequalification will meet the Essential Principles of Safety and Performance (hereafter
referred to as Essential Principles) when used in WHO Member States. WHO assessment
therefore recognizes the use of international standards as a means for a manufacturer to
demonstrate compliance with the Essential Principles and for the verification and validation
of their IVD.
Standards should represent the generally acknowledged state of technology and practice.
However, the preference for the use of recognized standards should not discourage the
introduction of new technologies. Not all IVDs, or elements of safety and/or performance,
may be addressed by recognized standards, especially for new types of IVDs and emerging
technologies.

4.2 Alternatives to international standards

In the absence of international standards or guidance, national, regional or industry
standards are another means of demonstrating conformity. For certain issues, relevant
international standards may not be available, are impractical or lacking in detail. In these
situations, recognized national guidance developed by stringent regulatory authorities should
be used as a reference. Guidance documents developed by such regulatory bodies have been
included in the list below for this purpose.
Manufacturers may use alternative solutions or standards not listed in this guidance
document to demonstrate their IVD meets the relevant Essential Principles (e.g. national
standards, industry agreed methods, internal manufacturer standard operating procedures).
The acceptability of such other solutions should be justified and may be subject to review by
WHO as part of the product assessment, as appropriate.

4.3 Use of standards by manufacturers

When using standards to demonstrate conformity to the Essential Principles and other
requirements, the manufacturer should:
 Identify the version and date of the relevant recognized standard(s) in its
technical documentation.
 Retain documentation to demonstrate that the device conforms to the
standard or the Essential Principles or alternatively include a declaration of
conformity to a recognized standard in the technical documentation to
substitute for the source document itself.

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If the standard used by the manufacturer is a superseded version of the recognized standard,
the manufacturer is not required to take any action unless there are safety implications, in
which case the manufacturer should implement a risk mitigation strategy and take
appropriate action to address these safety concerns.
If a manufacturer chooses not to apply a recognized standard in part or in full, this may be
acceptable if conformity with the Essential Principles can be demonstrated by another means
and/or the manufacturer can demonstrate that the standard or its parts are not applicable to
the IVD under assessment.

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5 Tables of standards
The tables below contain a list of applicable standard and guidance documents and have
been divided into the various stages in IVD design, manufacture and post market activities.
The tables list the source of the guidance document, the document number if applicable, the
document name and the date published. The following international standards and guidance
documents are given preference and listed in the order below in the tables
1. WHO,
2. Global Harmonization Task Force (GHTF)
3. International Medical Device Regulators Forum (IMDRF)
4. Asian Harmonization Working Party (AHWP)
5. International Organization for Standardization (ISO),
6. International Electrotechnical Commission (IEC), and
7. Clinical and Laboratory Standards Institute (CLSI).

National, regional or industry standards and guidance documents are an alternative when
international standards are not suitable or available and are listed in the latter part of the
following tables in italics.

5.1 Vocabulary
Source Document number Document name Date published
GHTF GHTF/SC/N4:2012 Glossary and Definitions of Terms Used in GHTF Nov-2012
(Edition 2) Documents
ISO/IEC ISO/IEC Guide International vocabulary of metrology -- Basic Dec-2007
99:2007 and general concepts and associated terms (VIM)
ISO ISO 9000:2015 Quality management systems – Fundamentals Sep-2015
and vocabulary
ISO ISO 3534-1:2006 Statistics -- Vocabulary and symbols -- Part 1: Oct-2006
General statistical terms and terms used in
probability
ISO ISO 3534-2:2006 Statistics -- Vocabulary and symbols -- Part 2: Sep-2006
Applied statistics
ISO ISO 3534-3:2013 Statistics -- Vocabulary and symbols -- Part 3: Apr-2013
Design of experiments

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5.2 IVD design

Source Document number Document name Date published
IEC IEC 62366:2015 Medical devices—Part 1: Application of usability Feb-2015
engineering to medical devices
IEC/TR IEC/TR 62366- Medical devices -- Part 2: Guidance on the Apr-2016
2:2016 application of usability engineering to medical
devices
CLSI MM03-Ed3 Molecular Diagnostic Methods for Infectious Feb-2015
Diseases, 3rd Edition
CLSI MM06-A2 Quantitative Molecular Methods for Infectious Nov-2010
Diseases; Approved Guideline - Second Edition
CLSI MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Feb-2014
Laboratory Medicine; Approved Guideline—
Second Edition
CLSI MM12-A Diagnostic Nucleic Acid Microarrays; Approved May-2006
Guideline
CLSI MM16-A Use of External RNA Controls in Gene Expression Aug-2006
Assays; Approved Guideline
CLSI MM17-A Verification and Validation of Multiplex Nucleic Mar-2008
Acid Assays; Approved Guideline
CLSI MM22-A Microarrays for Diagnosis and Monitoring of Feb-2014
Infectious Diseases; Approved Guideline
CLSI M53-A Criteria for Laboratory Testing and Diagnosis of Jun-2011
Human Immunodeficiency Virus Infection;
Approved Guideline
CLSI I/LA18-A2 Specifications for Immunological Testing for Sept-2001
Infectious Diseases; Approved Guideline
CLSI POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Aug-2006
Approved Guideline—Second Edition
CLSI POCT09-A Selection Criteria for Point-of-Care Testing Apr-2010
Devices; Approved Guideline
CEN EN 13641:2002 Elimination or reduction of risk of infection Dec-2002
related to in vitro diagnostic reagents
FDA 1546 Class II Special Controls Guidance Document: Mar-2005
Instrumentation for Clinical Multiplex Test
Systems - Guidance for Industry and FDA Staff
FDA 1620 Statistical Guidance on Reporting Results from Mar-2007
Studies Evaluating Diagnostic Tests
FDA 2231 Guidance for Industry and FDA Staff - Assayed Jun-2007
and Unassayed Quality Control Material
FDA 1646 Class II Special Controls Guidance Document: May-2008
Plasmodium Species Antigen Detection Assays
FDA 1737 In Vitro Companion Diagnostic Devices Aug-2014

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5.3 Risk
Source Document number Document name Date published
GHTF N045:2008 GHTF SG1 - Principles of In Vitro Diagnostic (IVD) Feb-2008
Medical Devices Classification
ISO ISO 14971:2007 Medical Devices – Application of Risk Mar-2007
Management to Medical Devices
ISO ISO/TR 24971:2013 Medical devices -- Guidance on the application of Jun-2013
ISO 14971
ISO ISO 14001:2004 Environmental management systems -- Nov-2004
Requirements with guidance for use
ISO Guide 73:2009 Risk management — Vocabulary Nov-2009
IEC IEC31010:2009 Risk management – Risk assessment techniques Nov-2009
ISO ISO 31000:2009 Risk management — Principles and guidelines Nov-2009
FDA 1772 Guidance for Industry and FDA Staff - Factors to Mar-2012
Consider When Making Benefit-Risk
Determinations in Medical Device Premarket
Approval and De Novo Classifications (PDF -
827KB)

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5.4 Manufacturing
Source Document number Document name Date published
WHO TGS 4 DRAFT Guidance on Test Method Validation of in Dec-2016
vitro diagnostic medical devices
WHO WHO TRS 996 Fiftieth report of the WHO Expert Committee on May 2016
Annex 5 specifications for pharmaceutical preparations.
(WHO technical report series ; no. 996)
Guidance on good data and record management
practices
ISO ISO 15198:2004 Clinical Laboratory Medicine - In Vitro Diagnostic Mar-2004
Medical Devices - Validation of User Quality
Control Procedures by the Manufacturer
CLSI EP18-A2 Risk Management Techniques To Identify And Nov-2009
Control Laboratory Error Sources; Approved
Guideline - Second Edition.
ANSI/ ANSI/ASQ Z1.4– Sampling Procedures and Tables for Inspection by 2013
ASQ 2003 (R2013) Attributes
CEN EN 13975:2003 Sampling procedures used for acceptance testing Nov-2003
of in vitro diagnostic medical devices - Statistical
aspects
Cenelec EN 61010-2- Safety requirements for electrical equipment for Dec-2002
101:2002 measurement, control, and laboratory use - Part
2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment
Cenelec EN 61326-2-6:2006 Electrical equipment for measurement, control Nov-2008
and laboratory use - EMC requirements - Part 2-6:
Particular requirements - In vitro diagnostic (IVD)
medical equipment

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5.5 Quality systems

Source Document number Document name Date published
GHTF GHTF/SG3/N19:20 Quality Management System - Medical Devices - 2-Nov-2012
12 Nonconformity Grading System for Regulatory
Purposes and Information Exchange
GHTF GHTF/SG3/N18:20 Quality Management System - Medical Devices - 4-Nov-2010
10 Guidance on Corrective Action and Preventive
Action and Related QMS Processes
GHTF GHTF/SG3/N17:20 Quality Management System - Medical Devices - 11-Dec-2008
08 Guidance on the Control of Products and Services
Obtained from Suppliers
GHTF SG3 N15R8 Implementation of Risk Management Principles 20-May-2005
and Activities within a Quality Management
System
GHTF GHTF/SG3/N99- Quality Management Systems - Process 02-Jan-2004
10:2004 Validation Guidance
GHTF GHTF/SG4/N30:20 Guidelines for Regulatory Auditing of Quality 27-Aug-2010
10 Management Systems of Medical Device
Manufacturers - Part 2: Regulatory Auditing
Strategy
GHTF GHTF/SG4/N83:20 Guidelines for Regulatory Auditing of Quality 27-Aug-2010
10 Management Systems of Medical Device
Manufacturers - Part 4: Multiple Site Auditing
GHTF GHTF/SG4/N84:20 Guidelines for Regulatory Auditing of Quality 27-Aug-2010
10 Management Systems of Medical Device
Manufacturers - Part 5: Audits of Manufacturer
Control of Suppliers
GHTF GHTF/SG4/N28R4: Guidelines for Regulatory Auditing of Quality 27-Aug-2008
2008 Management Systems of Medical Device
Manufacturers - Part 1: General Requirements
GHTF GHTF-SG4-N33 R16 Guidelines for Regulatory Auditing of Quality 02-Oct-2007
Management Systems of Medical Device
Manufacturers - Part 3: Regulatory Audit Reports
GHTF GHTF-SG4-(00)3 Training Requirements for Auditors 24-Feb-2000
ISO ISO 13485:2016 Medical devices - Quality management systems - 1Mar-2016
Requirements for regulatory purposes
ISO ISO 9000:2015 Quality management systems – Fundamentals 15-Sep-2015
and vocabulary
ISO ISO 9001:2015 Quality management systems - Requirements 15-Sept-2015
CLSI QMS02-A6 Quality Management System: Development and 28-Feb-2003
Management of Laboratory Documents;
Approved Guideline - Sixth Edition
CLSI POCT07-A Quality Management: Approaches to Reducing 7-Oct-2010
Errors at the Point of Care; Approved Guideline
CLSI EP18-A2 Risk Management Techniques To Identify And Nov-2009
Control Laboratory Error Sources; Approved
Guideline - Second Edition.
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Source Document number Document name Date published

FDA 21 CFR Part 820 Quality System Regulation
CEN EN 13975:2003 Sampling Procedures Used for Acceptance Testing 21-Nov-2003
of In Vitro Diagnostic Medical Devices - Statistical
Aspects

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5.6 Pre-market evaluation

Source Document number Document name Date published
GHTF GHTF/SG1/N68:2012 Essential Principles of Safety and Nov-2012
Performance of Medical Devices
GHTF SG1 N071:2012 Definition of the Terms ‘Medical Device’ and May-2012
‘In Vitro Diagnostic Medical Device’
GHTF GHTF/SG1/N063:2011 Summary Technical Documentation (STED) Mar-2011
for Demonstrating Conformity to the
Essential Principles of Safety and
Performance of In Vitro Diagnostic Medical
Devices
GHTF GHTF/SG1/N065:2010 Registration of Manufacturers and Other Aug-2010
Parties and Listing of Medical Devices
GHTF GHTF/SG1/N055:2009 Definition of the Terms Manufacturer, Mar-2009
Authorised Representative, Distributor and
Importer
GHTF N046:2008 Principles of Conformity Assessment for In Jul-2008
Vitro Diagnostic (IVD) Medical Devices
GHTF N044:2008 GHTF SG1 - Standards in the Assessment of Mar-2008
Medical Devices
IMDRF IMDRF/RPSWG/N13 In Vitro Diagnostic Medical Device Market Aug-2014
FINAL:2014 Authorization Table of Contents (IVD MA
ToC)
ISO 16142-2 Medical devices - Recognized essential Sept-2016
principles of safety and performance of
medical devices - Part 2: General essential
principles and additional specific essential
principles for all IVD medical devices and
guidance on the selection of standards
FDA 1584 Modifications to Devices Subject to Dec-2008
Premarket Approval (PMA) - The PMA
Supplement Decision
FDA 21 CFR Part 809 In Vitro Diagnostic Products for Human Use

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5.7 Analytical performance

Source Document number Document name Date published
WHO TGS-3 Principles of performance studies of an in vitro May-2016
Draft for public diagnostic for WHO Prequalification
comment
WHO TSS-1 Technical Specifications Series for submission to Dec-2016
ISBN 978-92-4- WHO Prequalification – Diagnostic Assessment:
151174-2 Human Immunodeficiency Virus (HIV) rapid
diagnostic tests for professional use and/or self-
testing
WHO TSS-2 Technical Specifications Series for submission to Dec-2016
ISBN 978-92-4- WHO prequalification – diagnostic assessment: in
151186-5 vitro diagnostics medical devices to identify
Glucose-6-phosphate dehydrogenase (G6PD)
activity
WHO TSS-3 Technical Specifications Series for submission to Dec-2016
ISBN 978-92-4- WHO prequalification – diagnostic assessment:
151227-5 Malaria rapid diagnostics tests
ISO ISO 15193:2009 In Vitro Diagnostic Medical Devices – May-2009
Measurement of Quantities in Samples of
Biological Origin – Requirements for Content and
Presentation of Reference Measurement
Procedures
ISO ISO 16269-4:2010 Statistical interpretation of data - Part 4: Oct-2010
Detection and treatment of outliers
ISO ISO 16269-6:2014 Statistical interpretation of data - Part 6: Jan-2014
Determination of statistical tolerance intervals
ISO ISO 16269-7:2001 Statistical interpretation of data - Part 7: Median Mar-2001
- Estimation and confidence intervals
ISO ISO 16269-8:2004 Statistical interpretation of data -- Part 8: Sep-2004
Determination of prediction intervals
ISO ISO 17511:2003 In Vitro Diagnostic Medical Devices – Aug-2003
Measurement of Quantities In Biological Samples
– Metrological Traceability of Values Assigned to
Calibrators and Control Materials
ISO ISO 5725-1:1994 Accuracy (trueness and precision) of Dec-1994
measurement methods and results - Part 1:
General principles and definitions
ISO ISO 5725-2:1994 Accuracy (trueness and precision) of Dec-1994
measurement methods and results - Part 2: Basic
method for the determination of repeatability
and reproducibility of a standard measurement
method
ISO ISO 5725-3:1994 Accuracy (trueness and precision) of Dec-1994
measurement methods and results - Part 3:
Intermediate measures of the precision of a
standard measurement method

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Source Document number Document name Date published

ISO ISO 5725-4:1994 Accuracy (trueness and precision) of Dec-1994
measurement methods and results - Part 4: Basic
methods for the determination of the trueness of
a standard measurement method
ISO ISO 5725-5:1998 Accuracy (trueness and precision) of Jul-1998
measurement methods and results - Part 5:
Alternative methods for the determination of the
precision of a standard measurement method
ISO ISO 5725-6:1994 Accuracy (trueness and precision) of Dec-1994
measurement methods and results - Part 6: Use
in practice of accuracy values
CLSI C24-A3 Statistical Quality Control for Quantitative Jun-2006
Measurement Procedures: Principles and
Definitions; Approved Guideline—Third Edition
CLSI EP05-A3 Evaluation of Precision of Quantitative Oct-2014
Measurement Procedures; Approved Guideline—
Third Edition
CLSI EP06-A Evaluation of the Linearity of Quantitative Apr-2003
Measurement Procedures: A Statistical Approach;
Approved Guideline
CLSI EP07-A2 Interference Testing in Clinical Chemistry; Nov-2005
Approved Guideline - Second Edition
CLSI EP09-A3 Measurement Procedure Comparison and Bias Aug-2013
Estimation Using Patient Samples; Approved
Guideline—Third Edition
CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Jan-2008
Performance; Approved Guideline— Second
Edition
CLSI EP15-A3 User Verification of Precision and Estimation of Sep-2014
Bias; Approved Guideline - Third Edition
CLSI EP17-A2 Evaluation of Detection Capability for Clinical Jun-2012
Laboratory Measurement Procedures; Approved
Guideline - Second Edition
CLSI EP18-A2 Risk Management Techniques to Identify and Nov-2009
Control Laboratory Error Sources; Approved
Guideline—Second Edition
CLSI EP21-A Estimation of Total Analytical Error for Clinical Apr-2003
Laboratory Methods; Approved Guideline
CLSI EP26-A User Evaluation of Between-Reagent Lot Sep-2013
Variation; Approved Guideline
CLSI EP27-A How to Construct and Interpret an Error Grid for Sep-2012
Quantitative Diagnostic Assays; Approved
Guideline
CLSI EP28-AC3 Defining, Establishing, and Verifying Reference Oct-2010
Intervals in the Clinical Laboratory; Approved
Guideline - Third Edition

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Source Document number Document name Date published

CLSI EP29-A Expression of Measurement Uncertainty in Jan-2012
Laboratory Medicine; Approved Guideline
CLSI EP30-A Characterization and Qualification of May-2010
Commutable Reference Materials for Laboratory
Medicine; Approved Guideline
CLSI EP32-R Metrological Traceability and Its Implementation; Feb-2006
A Report

CLSI I/LA30-A Immunoassay Interference By Endogenous Mar-2009

Antibodies; Approved Guideline
CLSI MM17-A:2008 Verification and Validation of Multiplex Nucleic Mar-2008
Acid Assays; Approved Guideline
ICH Q6B Current Step 4 ICH Harmonised Tripartite Guideline Mar-1999
version. Specifications: Test Procedures and Acceptance
Criteria for Biotechnological/Biological Products.
International Conference on Harmonization of
Technical Requirements for Registration of
Pharmaceuticals for Human Use. Current Step 4
version
ICH Q6A ICH Harmonised Tripartite Guideline. Oct-1999
Specifications: Test procedures and acceptance
criteria for new drug substances and new drug
products: chemical substances
European 2009/108/EC Commission Decision of 3 February 2009 Feb-2009
Commiss- amending Decision 2002/364/EC on common
ion technical specifications for in vitro-diagnostic
medical devices. Official Journal of the European
Union; L39/34-L39/49
Health Health Products and Food Branch: Guidance for Dec-2011
Canada Manufacturers of Human Immunodeficiency Virus
(HIV) Test Kits intended to be used in the
Laboratory

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5.8 Specimen collection and transport

Source Document number Document name Date published
CLSI MM13-A Collection, Transport, Preparation, and Storage Jan-2005
of Specimens for Molecular Methods; Approved
Guideline
CLSI M29-A4 Protection of Laboratory Workers From May-2014
Occupationally Acquired Infections; Approved
Guideline—Fourth Edition
CLSI GP34-A Validation and Verification of Tubes for Venous Dec-2010
and Capillary Blood Specimen Collection;
Approved Guideline
CLSI GP39-A6 Tubes and Additives for Venous and Capillary Dec-2010
Blood Specimen Collection; Approved Standard
- Sixth Edition
CLSI GP41-A6 Procedures for the Collection of Diagnostic Oct-2007
Blood Specimens by Venipuncture; Approved
Standard - Sixth Edition
CLSI GP42-A6 Procedures and Devices for the Collection of Sept-2008
Diagnostic Capillary Blood Specimens; Approved
Standard - Sixth Edition
CLSI GP44-A4 Procedures for the Handling and Processing of May-2010
Blood Specimens for Common Laboratory Tests;
Approved Guideline - Fourth Edition
CLSI NBS01-A6 Blood Collection On Filter Paper For Newborn Jul-2013
Screening Programs: Approved Standard - Sixth
Edition
CEN EN 14254:2004 In Vitro Diagnostic Medical Devices - Single-Use Apr-2005
Receptacles for the Collection of Specimens,
Other Than Blood, from Humans
CEN EN 14820:2004 Single-Use Containers for Human Venous Blood Apr-2005
Specimen Collection
FDA 1563 Guidance for Industry and FDA Staff - Class II Aug-2005
Special Controls Guidance Document: RNA
Preanalytical Systems (RNA Collection,
Stabilization and Purification Systems for RT-
PCR used in Molecular Diagnostic Testing)

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5.9 Stability
Source Document number Document name Date published
WHO TGS2 Establishing stability of an in vitro diagnostic for Dec-2015
Draft for Comment WHO Prequalification
ISO ISO 23640:2011 In Vitro Diagnostic Medical Devices – Evaluation Jan-2011
of Stability of In Vitro Diagnostic Reagents
CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Sep-2009
Reagents; Approved Guideline
CLSI M07-A10 Methods for Dilution Antimicrobial Jan-2015
Susceptibility Tests for Bacteria That Grow
Aerobically; Approved Standard—Tenth Edition
CLSI M11-A8 Methods for Antimicrobial Susceptibility Testing Feb-2012
of Anaerobic Bacteria; Approved Standard—
Eighth Edition
ASTM D4169 − 14 Standard Practice for Performance Testing of 2014
Shipping Containers and Systems
CEN EN 13640:2002 Stability testing of in vitro diagnostic reagents Dec-2002
European Ph. Eur. European Pharmacopoeia 8th Edition 2015
Union
Peoples 2000 Pharmacopoeia of the People’s Republic of 2000
Republic China. English edition.
of China
USP USP 31-NF 26 United States Pharmacopeia and National 2008
Formulary

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5.10 Self-testing considerations

Source Document number Document name Date published
WHO TSS-1 Technical Specifications Series for submission to Dec-2016
ISBN 978-92-4- WHO Prequalification – Diagnostic Assessment:
151174-2 Human Immunodeficiency Virus (HIV) rapid
diagnostic tests for professional use and/or self-
testing
ISO ISO 15197:2013 In vitro diagnostic test systems - Requirements May-2013
for blood-glucose monitoring systems for self-
testing in managing diabetes mellitus
EN EN 13532:2002 General requirements for in vitro diagnostic May-2002
medical devices for self-testing
FDA 1756 Self-Monitoring Blood Glucose Test Systems for Jan-2014
Over-the-Counter Use

5.11 Flex studies (Robustness)

Source Document number Document name Date published
FDA 1757 Guidance for Industry and Food and Drug Feb-2016
Administration Staff : Applying Human
Factors and Usability Engineering to Medical
Devices
ANSI/A HE75:2009/(R)2013 2013 Human factors engineering – Design of Nov-2013
AMI medical devices

5.12 Clinical performance

Source Document number Document name Date published
WHO TGS-3 Principles of performance studies of an in vitro May-2016
Draft for public diagnostic for WHO Prequalification
comment
WHO TSS-1 Technical Specifications Series for submission to Dec-2016
ISBN 978-92-4- WHO Prequalification – Diagnostic Assessment:
151174-2 Human Immunodeficiency Virus (HIV) rapid
diagnostic tests for professional use and/or self-
testing
WHO TSS-2 Technical Specifications Series for submission to Dec-2016
ISBN 978-92-4- WHO prequalification – diagnostic assessment: in
151186-5 vitro diagnostics medical devices to identify
Glucose-6-phosphate dehydrogenase (G6PD)
activity
WHO TSS-3 DRAFT Technical Specifications Series for Dec-2016
ISBN 978-92-4- submission to WHO prequalification – diagnostic
151227-5 assessment: Malaria rapid diagnostics tests
GHTF GHTF/SG5/N5:2012 Reportable Events During Pre-Market Clinical Aug-2012

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Investigations
GHTF GHTF/SG5/N6:2012 Clinical Evidence for IVD Medical Devices - Key Nov-2012
Definitions and Concepts
GHTF GHTF/SG5/N7:2012 Clinical Evidence for IVD Medical Devices - Nov-2012
Scientific Validity Determination and Performance
Evaluation
GHTF GHTF/SG5/N8:2012 Clinical Evidence for IVD Medical Devices - Clinical Nov-2012
Performance Studies for In Vitro Diagnostic
Medical Devices
ISO ISO 14155:2011 Clinical investigation of medical devices for human Feb-2011
subjects -- Good clinical practice
ISO ISO 22870:2006 Point-of-care testing (POCT) -- Requirements for Feb-2006
quality and competence
ISO ISO 15189:2012 Medical laboratories -- Requirements for quality Nov-2011
and competence
CLSI EP09-A3 Measurement Procedure Comparison and Bias Aug-2013
Estimation Using Patient Samples; Approved
Guideline - Third Edition
CLSI EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical May-2014
Laboratory Measurement Procedures; Approved
Guideline - Third Edition
CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test -Jan-2008
Performance; Approved Guideline - Second Edition
CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Aug-2014
Approved Guideline - Third Edition
CLSI EP24-A2 Assessment of the Diagnostic Accuracy of Nov-2011
Laboratory Tests Using Receiver Operating
Characteristic Curves; Approved Guideline - Second
Edition
CLSI I/LA21-A2 Clinical evaluation of immunoassays; Approved Aug-2008
guideline
CEN EN Performance Evaluation of In Vitro Diagnostic Dec-2009
13612:2002/AC:200 Medical Devices
2
CEN EN 13532:2002 General requirements for in vitro diagnostic Dec-2002
medical devices for self-testing
European 2009/108/EC Commission Decision of 3 February 2009 amending Feb-2009
Commiss- Decision 2002/364/EC on common technical
ion specifications for in vitro-diagnostic medical
devices. Official Journal of the European Union;
L39/34-L39/49
FDA 1587 Guidance for Industry and FDA Staff: In Vitro Jun-2010
Diagnostic (IVD) Device Studies - Frequently Asked
Questions
World Not applicable DECLARATION OF HELSINKI Ethical Principles for Oct-2013
Medical Medical Research Involving Human Subjects
Associati
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on
MHRA Guidance for notified bodies on the regulation of July 2012
IVDs for self-testing
Health Health Products and Food Branch: Guidance for Dec-2011
Canada Manufacturers of Human Immunodeficiency Virus
(HIV) Test Kits intended to be used in the
Laboratory
TGA Clinical performance requirements and risk Mar-2015
mitigation strategies for HIV tests version 1.0

5.13 Labelling
Source Document number Document name Date published
WHO TRS No. 970 Forty-sixth report of the WHO Expert Committee Jun-2012
Annex 4 on specifications for pharmaceutical
preparations. (WHO technical report series ; no.
970)
Guidelines on submission of documentation for a
multisource (generic) finished pharmaceutical
product for the WHO Prequalification of
Medicines Programme: quality part
WHO / Purchasing and Using RDTs – RDT instructions 2009
FIND / and training
TDR /
Roll
Back
Malaria
GHTF GHTF/SG1/N70:20 Label and Instruction for Use for Medical Devices Sept-2011
11
IMDRF IMDRF/UDIWG/N7 UDI Guidance: Unique Device Identification (UDI) Dec-2013
FINAL:2013 of Medical Devices
ISO ISO 18113-1:2009 In Vitro Diagnostic Medical Devices - Information Dec-2009
Supplied by the Manufacturer (Labelling) - Part 1:
Terms, Definitions and General Requirements
ISO ISO 18113-2:2009 In Vitro Diagnostic Medical Devices. Information Dec-2009
Supplied by the Manufacturer (Labelling) - Part 2:
In Vitro Diagnostic Reagents for Professional Use
ISO ISO 18113-3:2009 In Vitro Diagnostic Medical Devices - Information Dec-2009
Supplied by the Manufacturer (Labelling) – Part
3: In Vitro Diagnostic Instruments for Professional
Use
ISO ISO 18113-4:2009 In Vitro Diagnostic Medical Devices – Information Dec-2009
Supplied by the Manufacturer (Labelling) – Part
4: In Vitro Diagnostic Reagents for Self-Testing
ISO ISO 18113-5:2009 In Vitro Diagnostic Medical Devices – Information Dec-2009
Supplied by the Manufacturer (Labelling) – Part

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5: In Vitro Diagnostic Instruments for Self-Testing

ISO ISO 15223-1:2016 Medical Devices – Symbols to be Used with 02-Nov-2016
Medical Device Labels, Labelling and Information
to be supplied - Part 1: General requirements
FDA 1128 Guidance on Medical Device Patient Labeling; Apr-2001
Final Guidance for Industry and FDA Reviewers
FDA Write it Right: Recommendations for Developing Aug-1993
User Instruction Manuals for Medical Devices
Used in Home Health Care
FDA 2003D-0383 Use of Symbols on Labels and in Labelling of In Nov-2004
Vitro Diagnostic Devices Intended for Professional
Use
FDA 1750 Guidance for Industry and Food and Drug Nov-2014
Administration Staff. Design Considerations for
Devices Intended for Home Use
Europe MEDDEV. 2.14/3 Guidelines on medical devices. IVD guidances: Jan-2007
an rev.1 Supply of Instructions For Use (IFU) and other
Commis information for In-vitro Diagnostic (IVD) Medical
sion Devices. A guide for manufacturers and notified
bodies
CEN EN 13532:2002 General requirements for in vitro diagnostic Dec-2002
medical devices for self-testing
CEN EN 980:2008 Symbols for use in the labelling of medical devices Jul-2008
Health Guidance Document - Labelling of In Vitro Apr-2016
Canada Diagnostic Devices
MHRA Guidance for notified bodies on the regulation of Jul-2012
IVDs for self-testing

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5.14 Software
Source Document number Document name Date published
IMDRF IMDRF/SaMDWG/ Software as a Medical Device: Possible 18-Sep-2014
N12 FINAL:2014 Framework for Risk Categorization and
Corresponding Considerations
IMDRF IMDRF/SaMDWG/ Software as a Medical Device (SaMD): Key 18-Dec-2013
N10 FINAL:2013 Definitions
IEC IEC 62304:2006- Medical Device Software - Software Life Cycle May-2006
Ed.1.0 Processes
ANSI/ TIR80002-1:2009 Medical device software – Part 1: Guidance on 24-Dec-2009
AAMI/ the application of ISO 14971 to medical device
IEC software
CLSI AUTO11-A2 Information Technology Security of In Vitro 31-Oct-2014
Diagnostic Instruments and Software Systems;
Approved Standard - Second Edition
CLSI AUTO13-A2 Laboratory Instruments and Data Management
Systems: Design of Software User Interfaces and
End-User Software Systems Validation,
Operation, and Monitoring; Approved
Guideline—Second Edition
FDA 337 Guidance for the Content of Premarket 11-May-2005
Submissions for Software Contained in Medical
Devices
FDA 585 Guidance for Industry, FDA Reviewers and 09-Sep-1999
Compliance on Off-The-Shelf Software Use in
Medical Devices
FDA 1553 Guidance for Industry - Cybersecurity for 14-Jan-2015
Networked Medical Devices Containing Off-the-
Shelf (OTS) Software
FDA 1500067 Dissemination of Patient-Specific Information 10-Jun-2016
from Devices by Device Manufacturers (Draft
guidance)
FDA 1400044 Guidance for Industry and Food and Drug 28-Dec-2016
Administration Staff: Postmarket Management of
Cybersecurity in Medical Devices
Europe MEDDEV 2.1/6 Qualification and Classification of Stand Alone Jan-2012
an Software
Commis
sion

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5.15 Post Market Surveillance

Source Document number Document name Date published
WHO ISBN 978 92 4 150921 3 Post-Market Surveillance of In Vitro 2015
Diagnostics
GHTF SG2 N87:2012 An XML Schema for the Electronic Transfer 27-Jul-2012
of Adverse Event Data between
Manufacturers, Authorised Representatives
and National Competent Authorities (Based
on GHTF/SG2/N54: 2006)
GHTF SG2 N87:2012 XML Schema for Electronic Transfer of 27-Jul-2012
Adverse Event Data - XLS
GHTF GHTF/SG2/N38R19:2009 Application Requirements for Participation 01-Jul-2009
in the GHTF National Competent Authority
Report Exchange Program
GHTF GHTF/SG2/N79R11:2009 Medical Devices: Post Market Surveillance: 17-Feb-2009
National Competent Authority Report
Exchange Criteria and Report Form
GHTF GHTF/SG2/N54R8:2006 Medical Devices Post Market Surveillance: 30-Nov-2006
Global Guidance for Adverse Event
Reporting for Medical Devices
GHTF GHTF/SG2/N57R8:2006 Medical Devices Post Market Surveillance: 27-Jun-2006
Content of Field Safety Notices
GHTF GHTF/SG2/N47R4:2005 Review of Current Requirements on 01-May-2005
Postmarket Surveillance
GHTF GHTF/SG2/N68R3:2005 Summary of Current Requirements for 01-May-2005
Where to Send Adverse Event Reports
GHTF GHTF/SG2/N61R4:2004 PMS Harmonization Chart 01-Nov-2004
GHTF GHTF/SG2/N31R8:2003 Medical Device Postmarket Vigilance and 01-Feb-2003
Surveillance: Proposal for Reporting of Use
Errors with Medical Devices by their
Manufacturer or Authorized Representative
GHTF GHTF/SG2/N32R5:2002 Medical Device Postmarket Vigilance and 01-Feb-2003
Surveillance: Universal Data Set for
Manufacturer Adverse Event Reports
GHTF GHTF/SG2/N9R11:2003 Global Medical Devices Competent 01-Jan-2003
Authority Report
GHTF GHTF/SG2/N36R7:2003 Manufacturer's Trend Reporting of Adverse 01-Jan-2003
Events
GHTF GHTF/SG2/N33R11:2002 Medical Device Postmarket Vigilance and 27-Sep-2007
Surveillance: Timing of Adverse Event
Reports
GHTF GHTF/SG2/N6R3:2002 GHTF SG2 - Comparison of the Device 21-May-2002
Adverse Reporting Systems in USA, Europe,
Canada, Australia & Japan
GHTF GHTF/SG2/N20R10:2002 GHTF SG2 - Medical Devices: Post Market 21-May-2002
Surveillance: National Competent Authority
Report Exchange Criteria
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Source Document number Document name Date published

GHTF GHTF-SG2-N008R4 Guidance on How to Handle Information 29-Jun-1999
Concerning Vigilance Reporting Related to
Medical Devices
IMDRF AE WG(PD1)/N43R1 PROPOSED DOCUMENT IMDRF 22-Jul-2016
terminologies for categorized Adverse Event
Reporting (AER): terms, terminology
structure and codes
IMDRF IMDRF/NCAR WG/N14 Medical Devices: Post-Market Surveillance: 26-Mar-2016
FINAL:2015 National Competent Authority Report
Exchange Criteria and Report Form.
ISO 2859-10:2006 Sampling procedures for inspection by 01-Jul-2006
attributes - Part 10: Introduction to the ISO
2859 series of standards for inspection by
attributes
CEN EN 14136:2004 Use of external quality assessment schemes 15-Nov-2006
in the assessment of the performance of in
vitro diagnostic examination procedures
European MEDDEV 2.12-1 rev 8 Guidelines on a Medical Devices Vigilance Jan-2013
Commis- Vigilance System
ion

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5.16 Changes
Source Document number Document name Date published
WHO WHO/EMP/RHT/P Reportable Changes to a WHO Dec-2016
QT/2016.01 Prequalified In Vitro Diagnostic Medical Device
AHWP AHWP/WG1/PF002 Guidance for Minor Change Reporting Nov-2016
:2016
NBOG NBOG BPG 2014-3 Guidance for manufacturers and Notified Bodies Mar-2014
on reporting of Design Changes and Changes of
the Quality System
FDA 1500054 Draft Guidance for Industry and Food and Drug 08-Aug-2016
Administration Staff. Deciding When to Submit
a 510(k) for a Change to an Existing Device.
Center for Biologics Evaluation and Research,
MD, USA; 1997
FDA 1584 Guidance for Industry and FDA Staff. 11-Dec-2008
Modifications to Devices Subject to Premarket
Approval (PMA) – The PMA supplement
decision-making process.
FDA 950 Guidance for Industry and FDA Staff; 11-Dec-2003
Replacement Reagent and Instrument Family
Policy
FDA FDA-2008-N-0642 Assay Migration Studies for In Vitro Diagnostic 25-Apr-2013
Devices
FDA 1584 Modifications to Devices Subject to Premarket 11-Dec-2008
Approval (PMA) - The PMA Supplement Decision
Health Guidance for the Interpretation of Significant 20-Jan-2011
Canada Change of a Medical Device

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6 Websites with additional information

Source Website address

AHWP Reference and guidance documents:
http://www.ahwp.info/index.php?q=node/287$
http://www.ahwp.info/index.php?q=taxonomy/term/20
ANSI Documents available for purchase:
http://webstore.ansi.org/
ASTM Documents available for purchase:
https://www.astm.org/Standard/standards-and-publications.html
CLSI Documents available for purchase:
http://shopping.netsuite.com/clsi
European IVD directives and the list of harmonized standards (CEN or Cenelec) published in the
Union and Official Journal of the European Union
European http://ec.europa.eu/growth/single-market/european-standards/harmonised-
Commission standards/iv-diagnostic-medical-devices/

Medical device guidelines

http://ec.europa.eu/growth/sectors/medical-devices/guidance_en
FDA Complete list of IVD-related guidance documents:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm070274.htm
Device Advice (regulatory information resource for medical device manufacturers)
http://www.fda.gov/medicaldevices/deviceregulationandguidance/default.htm
FIND Training material for Malaria rapid diagnostics tests
https://www.finddx.org/implementation-resources/
GHTF and GHTF documents
IMDRF http://www.imdrf.org/ghtf/ghtf-archived-docs.asp
IMDRF documents
http://www.imdrf.org/documents/documents.asp#imdrf
Health Therapeutic Products Directorate's List of Recognized Standards for Medical Devices:
Canada http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-
normes/md_rec_stand_im_norm_lst-eng.php

ICH Full list of ICH guidelines:

http://www.ich.org/products/guidelines.html
IEC Documents available for purchase:
https://webstore.iec.ch/?ref=menu
ISO Documents available for purchase:
http://shopping.netsuite.com/s.nl/c.1253739/sc.7/category.2406/.f
TGA List of guidance documents
https://www.tga.gov.au/standards-guidelines-publications-medical-devices-ivds
USP Documents available for purchase:
http://www.usp.org/products

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WHO WHO Prequalification- Diagnostic assessment documents:

http://www.who.int/diagnostics_laboratory/guidance/en/
http://www.who.int/diagnostics_laboratory/evaluations/en/
http://www.who.int/diagnostics_laboratory/postmarket/en/

WHO Expert Committee on Specifications for Pharmaceutical Preparations Technical

Report Series
http://www.who.int/medicines/publications/pharmprep/en/

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7 References

1 GHTF/SG1/N68:2012.Essential Principles of Safety and Performance of Medical Devices.

Global Harmonization Task Force (GHTF) Steering Committee; 2012.
2 GHTF/SC/N4:2012 (Edition 2). Glossary and Definitions of Terms Used in GHTF Documents.
Global Harmonization Task Force (GHTF) Steering Committee; 2012.
3 ISO/IEC Guide 2:2004. Standardization and related activities - General vocabulary. Geneva,
International Organization for Standardization/International Electrotechnical Commission;
2004.

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