The ISO 20916:2019 standard “In vitro diagnostic Medical Devices – Clinical performance studies using specimens from human subjects – Good study practice” provides detailed information on Clinical Performance Studies (CPS) for in vitro Diagnostic Medical Devices.
What is the purpose of ISO 20916?
Clinical performance studies for in vitro Diagnostic Medical Devices are essential if analytical performance studies or methods such as literature research are not sufficient to assess the performance of the IVD device.
For a long time there has been a lack of clear guidelines on the design and management of performance studies for IVD devices. This gap was filled in 2019 with ISO 20916:2019.
ISO 20916 is intended to define good study practices for the planning, design, conduct, registration and reporting of clinical performance studies.
These clinical performance studies allow the safety of in vitro Diagnostic Medical Devices to be evaluated.
Clinical Performance Studies for IVD Medical Devices
Clinical performance measures the ability of an IVD Device to produce results related to a particular clinical condition or physiological/pathological condition in accordance with its intended use.
Clinical performance studies are undertaken to verify or confirm aspects of IVD Device performance that cannot be determined by analytical performance studies and by the pertinent literature. This information is then used to demonstrate compliance with the relevant general safety and performance requirements.
Clinical performance studies should be conducted taking every precaution to protect the health and safety of the patient, taking into account all regulatory and ethical requirements and using sound scientific principles, such as:
- ethical and regulatory considerations;
- design and planning of the study;
- data monitoring;
- reporting of adverse events.
Types of clinical performance studies
There are two types of clinical performance studies:
Observational (non-interventional) studies in which test results do not influence patient management and treatment decisions and interventional studies in which test results may influence patient management decisions and treatment.
These studies must be undertaken within the framework of an effective Quality Management System to ensure compliance with ISO 20916.
Are you an IVD Medical Device Manufacturer?
If you are planning to conduct or are already conducting clinical performance studies, you should carefully read ISO 20916 and comply with the standard.
In addition, if you would like to receive useful information on the obligations and requirements to be met by 26 May 2022, the date when the IVDR (EU) 2017/746 is to come into full effect, we recommend that you download our White Paper “IVDR (EU) 2017/746 Factsheet for Manufacturers of in vitro Diagnostic Medical Devices”
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