Clinical performance studies using specimens from human subjects

New international standard provides good study practice for in vitro diagnostic medical devices

ISO 20916 - In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice - was published in May 2019. It is the first edition of a standard on this subject. It provides requirements and guidance for manufacturers, clinicians, or researchers who execute clinical performance studies in support of regulatory requirements for in-vitro diagnostic medical devices (IVDs).  The scope of the standard covers from initial planning of the study to the final report stage. ISO 20916 has been included in the draft standardization request from the European Union to support regulatory requirements in executing clinical performance studies for IVDs contained in the In Vitro Medical Device Regulations.

Development of ISO 20916 started in late 2014.  At this time, IVD manufacturers conducting clinical performance studies had to review country specific regulations or identify applicable elements in other documents.

The initial efforts to develop ISO 20916 considered synergies with ISO 14155:2011. ISO 14155- Clinical investigation of medical device for human subjects- Good clinical practice - relates to clinical investigations for medical device rather than clinical performance studies for IVDs. ISO 14155 is currently at the final stages of revision. IVDs utilize specimens taken from the human body for diagnosis or monitoring. Their intended use is distinct from that of medical devices.  The potential harm, and associated risk to the patient, associated with IVD devices is generally related to erroneous results obtained from the device or collection procedures.  ISO 20916 is intended to provide requirements and guidance for execution of IVD clinical performance studies in one document, taking into consideration the aspects from the already available standards.

ISO 20916 is structured to accommodate clinical performance studies on all types of IVDs. It recognises that clinical performance studies can vary with respect to:

• the route of obtaining test samples (fresh samples, or leftover or archived specimens)
• objectives of the study
• differences in study design (non-interventional, interventional)

The standard provides requirements and guidance for:

• ethical considerations
• study planning
• site initiation
• study conduct
• study closeout

Annexes to the standard provide more detail with additional requirements and recommendations to the main body. These Annexes are intended for:

• studies that are interventional (i.e. studies where results may be used for patient management or treatment)
• studies in which the specimen collection poses additional risk

A flowchart is provided to assist users in navigating through the standard.

In addition, there are two further informative Annexes that cover: 

• good clinical performance study documentation - with an aid to assist users in keeping track of the documentation and records needed for a particular study
• auditing - providing information on the value of independent audits to ensure clinical study compliance with i) the clinical performance study protocol, ii) the study procedures, and iii) ISO 20916

ISO 20916 is a source of information for those conducting clinical performance studies on IVDs using specimens taken from human subjects. BSI’s Compliance Navigator can also help you understand the requirements.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development