What is ISO 20916 - Clinical performance studies of In vitro diagnostic (IVD) medical devices about?

ISO 20916 discusses In vitro diagnostic (IVD) medical devices. ISO 20916 is an international standard on clinical performance studies of In vitro diagnostic medical devices.

ISO 20916 outlines good study practice for the planning, design, conduct, recording, and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.

ISO 20916 identifies the principles that underpin clinical performance studies and specifies general requirements intended to:

Ensure the conduct of the clinical performance study that led to reliable and robust study results
Define the responsibilities of the sponsor and principal investigator
Assist sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of In-vitro medical devices
Protect the rights, safety, dignity, and well-being of the subject by providing specimens for use in clinical performance studies

Clinical performance studies that are performed for reasons other than pre-market and post-market regulatory purposes, such as for reimbursement purposes, are out of the scope of ISO 20916.

Note 1: ISO 20916 is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.

Note 2: Analytical performance studies are out of the scope of this document ISO 20916.

Note 3: When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of ISO 20916 (particularly the annexes) can be useful for ensuring subject safety.

Note 4: Some of the elements of ISO 20916 can be useful for the design of such studies, including subject safety and data integrity.

Who is ISO 20916 - Clinical performance studies of IVD for?

ISO 20916 on clinical performance studies using specimens from human subjects is relevant to:

Manufacturers of In vitro diagnostic medical devices
In vitro diagnostic clinics
Test centers for In vitro diagnostic medical devices
Regulatory authorities
Clinical research organizations
Investigators
Assist sponsors

Why should you use ISO 20916 - Clinical performance studies of IVD?

In vitro diagnostic (IVD) medical devices are used to conduct tests outside of the human body to provide valuable information regarding a person’s health or physiological status. They include tests and related devices, such as test strips and reagents, using specimens such as blood, tissue, or urine, to carry out screening, diagnosis, prognosis, predictive testing, and monitoring of conditions.

ISO 20916 guidelines assist you with ethical considerations, clinical performance study planning, recording of specimen information, specimen accountability, specimen integrity study site initiation, clinical performance study conduct, and close-out for clinical performance studies using specimens from human subjects.

This guides in the proper collection and evaluation of specimens. In addition, ensures good study practices are followed for In vitro diagnostic medical devices.

ISO 20916 also guides on the requirements for the various situations for In vitro diagnostic (IVD) medical devices.

BS ISO 20916:2019

In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

Current

Published:

30 Jun 2019