ISO/TS 16766:2024
(Main)Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
This document provides guidance to manufacturers on the minimum requirements for the lifecycle management of in vitro diagnostic (IVD) medical devices that are developed in preparation for and in response to a public health emergency involving infectious agents requiring immediate availability of authorized IVD devices. NOTE This document does not replace existing national (or regional) regulatory pathway requirements for IVD medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical devices is country-specific and it includes: — following a risk management process; — monitoring the device’s post-market performance and quality assurance; — implementing a communication system.
Aspects à prendre en compte par les fabricants de dispositifs médicaux de diagnostic in vitro en situation d’urgence de santé publique
General Information
Standards Content (Sample)
Technical
Specification
ISO/TS 16766
First edition
Manufacturers’ considerations for
2024-11
in vitro diagnostic medical devices
in a public health emergency
Aspects à prendre en compte par les fabricants de dispositifs
médicaux de diagnostic in vitro en situation d’urgence de santé
publique
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations for the design and development process . 5
4.1 Safety and performance requirements .5
4.2 Quality management and risk management .6
4.3 Target condition and scientific validity .6
4.4 Assay technology .6
4.5 Intended use and risks and benefits of the device .6
4.6 Analytical performance .7
4.7 Stability .7
4.8 Clinical performance .7
5 General considerations for the risk management process . 8
5.1 General .8
5.2 Risk reduction .8
6 Monitoring the device’s post-market performance and quality assurance . 9
6.1 General .9
6.2 Monitoring post-market performance.9
6.3 Quality assurance .9
7 Implementing a communication process . 10
7.1 Establishing a communication process .10
7.2 Manufacturer responsibility .10
Bibliography .11
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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This document was prepared by Technical Committee ISO/TC 212, Medical laboratories and in vitro diagnostic
systems.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
During a pandemic, accurate identification and isolation of infected individuals is an effective initial response
to secure public health and safety before vaccines are available. The coronavirus disease of 2019 (COVID-19)
posed an unprecedented public health emergency, causing many countries to impose restrictions on travel
and daily activities to slow the spread of infection. An example where the spread of COVID-19 infection was
[1]
demonstrated to have been slowed before vaccines became available has been published. Here, a series of
interventions, such as the urgent introduction of appropriate emergency use in vitro diagnostic (emergency
use-IVD) medical devices, aggressive testing, rigorous contact tracing, etc., were applied in the early stage
of the pandemic. Such a series of interventions effectively slowed the spread of infections and succeeded in
maintaining public health and safety without the collapse of intensive care capabilities.
Often, regulatory authorization of in vitro diagnostic (IVD) medical devices takes months to a year or more to
review and approve under a traditional regulatory pathway. Following a global infectious disease outbreak
such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), the need
for an accelerated regulatory pathway to facilitate the introduction of emergency use-IVD medical devices
was recognised. While such pathways (i.e. emergency use authorization processes) have been implemented,
[2-14]
the processes for authorization are neither well established nor harmonized.
While some international guidance is available for the minimum requirements for an IVD medical device in a
public health emergency, the regulatory requirements can differ from one jurisdiction to another. For example,
information on the quality system (e.g. ISO 13485), developmental history, or raw materials/manufacturing
methods are required when a manufacturer applies for the accelerated regulatory pathway in some countries
but not in others. Also, some countries require a stability shelf life claim, but the level of evidence required
[2,11,16,17]
to demonstrate stability during the initial application varies by region. In an urgent situation such
as a pandemic, the application of non-standardized requirements can impede implementation of the use of
emergency use-IVD medical devices that are critical in protecting global public health.
This document provides minimum requirements, which span pre-market to post-market activities, to
accelerate the availability of IVD medical devices in a public health emergency.
v
Technical Specification ISO/TS 16766:2024(en)
Manufacturers’ considerations for in vitro diagnostic medical
devices in a public health emergency
1 Scope
This document provides guidance to manufacturers on the minimum requirements for the lifecycle
management of in vitro diagnostic (IVD) medical devices that are developed in preparation for and in
response to a public health emergency involving infectious agents requiring immediate availability of
authorized IVD devices.
NOTE This document does not replace existing national (or regional) regulatory pathway requirements for IVD
medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical
devices is country-specific and it includes:
— following a risk management process;
— monitoring the device’s post-market performance and quality assurance;
— implementing a communication system.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
adverse event
untoward medical occurrence, inappropriate patient management decision, unintended disease or injury, or
untoward clinical sign in subjects, users, or other persons, with any connection to study related activities,
whether or not related to the IVD medical device (3.9) under investigation
Note 1 to entry: Adverse events can be caused by, for instance, insufficient or inadequate instructions for use,
deployment, installation, operation, or any malfunction of the IVD medical device under investigation.
Note 2 to entry: This definition includes the malfunction or deterioration of a device which has not yet caused death or
serious injury, but which can lead to death or serious injury.
Note 3 to entry: This definition is not intended to be used in determining whether an event is reportable to a regulatory
authority.
Note 4 to entry: For users or other persons, this definition is restricted to events related to investigational IVD medical
devices.
Note 5 to entry: False negative or false positive results are not considered adverse events unless, in an interventional
study, inappropriate patient management decisions are made based on those false results.
[SOURCE: ISO 20916:2019, 3.2]
3.2
analytical performance
ability of an IVD medical device (3.9) to detect or measure a particular analyte or measurand
Note 1 to entry: In metrological terms, this is referred to as performance of a measuring instrument or measuring system.
[SOURCE: ISO 18113-1:2022, 3.2.3, modified — in the definition, “or measurand” was added; Note 1 to entry
was added.]
3.3
analytical sensitivity
quotient of the change in a measurement indication and the corresponding change in a value of a quantity
being measured
Note 1 to entry: The sensitivity of a measurement procedure can depend on the value of the quantity being measured.
Note 2 to entry: The change considered in the value of the quantity
...
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