In the continually evolving field of medical diagnostics, the introduction of ISO 20916:2019 has marked a significant milestone. Published in May 2019, this International Standard, the first of its kind, meticulously outlines the parameters for clinical performance studies using specimens from human subjects, specifically focusing on in-vitro diagnostic medical devices (IVDs). These devices, instrumental in the analytical examination of human samples like blood, tissue, or urine outside the body, play a pivotal role in various diagnostic procedures, including screening, prognosis, predictive testing, and monitoring of health conditions.
Distinct from other medical devices, IVDs operate outside the human body, which inherently alters the risk characteristics and necessitates unique performance standards. Recognizing this, ISO 20916:2019 establishes itself as a stand-alone standard catering exclusively to IVDs, employing definitions and concepts that reflect the intricacies of these devices. Particularly for integrated systems utilizing both IVDs and other medical devices, this standard functions in tandem with ISO 14155:2020, ensuring comprehensive coverage of all regulatory needs.
Deemed the gold standard, ISO 20916:2019 epitomizes good study practice, guiding the planning, design, conduct, recording, and reporting of clinical performance studies. This is crucial for assessing the clinical performance and safety of IVDs for regulatory compliance. It meticulously underscores principles for reliable study results, delineates responsibilities of sponsors and principal investigators, and assists various stakeholders involved in the conformity assessment of IVDs. Paramount among its guidelines is the protection of the rights, safety, dignity, and well-being of subjects contributing specimens.
In-vitro diagnostic medical devices
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. IVDs 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 conditions.
IVD medical devices are fundamentally different from other medical devices because they perform their function outside of the body on specimens taken from the human body. Human subjects are typically not exposed to risks with IVD medical devices’ performance testing, except for the risk associated with specimen collection procedures or when the obtained information is used for patient management. These differences make the performance and risk characteristics of IVD medical devices different and unique from other medical devices.
The ISO 20916:2019 is specific for IVD medical devices
The ISO 20916:2019 is specific for IVD medical devices and uses definitions and concepts appropriate for IVD medical devices. It is a stand-alone standard for clinical performance studies for IVD medical devices. In the situation for which there are an IVD medical device and a medical device used in an integrated system, both ISO 20916:2019 and ISO 14155:2020 might need to be considered.
ISO 20916:2019 is the gold standard describing good study practice for the planning, design, conduct, recording, and reporting of clinical performance studies to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
This ISO standard identifies the principles that underpin clinical performance studies and specifies general requirements intended to:
- ensure the conduct of the clinical performance study will lead to reliable and robust study results
- define the responsibilities of the sponsor and principal investigator
- assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of IVD medical devices
- protect the rights, safety, dignity, and well-being of the subjects providing specimens for use in clinical performance studies
The development process for in vitro diagnostic medical devices is complex. This, combined with a high degree of new IVDR requirements have made the IVDD to IVDR transition a complicated and time-consuming process for most device manufacturers. Manufacturers of in vitro diagnostic medical devices should:
- carefully study the requirements of the new IVDR
- implement clinical evaluation procedures related to ISO 20916perform an assessment of how their current product portfolio may be impacted by the new regulation
- start clinical performance studies to ensure sufficient clinical evidence are available for their products
Analytical performance studies, and clinical performance studies performed for reasons other than pre-and post-market regulatory purposes, such as for reimbursement purposes, are out of the scope of the ISO 20916 standard.
