What is BS EN ISO 20916 – In vitro clinical performance studies about?
To help with regulatory compliance, robust results and ethical considerations, BS EN ISO 20916:2024 is a stand-alone international standard that defines good practice for clinical performance studies of IVD medical devices when specimens from human subjects are used.
Who is BS EN ISO 20916 – In vitro clinical performance studies for?
- Manufacturers of in vitro diagnostic medical devices
- In vitro diagnostic clinics
- Test centres for in vitro diagnostic medical devices
- Regulatory authorities
- Clinical research organizations
- Investigators
- Sponsors
What does BS EN ISO 20916 – In vitro clinical performance studies cover?
It defines good study practice for the planning, design, conduction, recording and reporting of clinical performance studies. These studies are carried out to assess the clinical performance and safety of in vitro diagnostic medical devices (IVD) for regulatory purposes.
BS EN ISO 20916:2024 identifies the principles that underpin clinical performance studies and specifies general requirements.
Why should you use BS EN ISO 20916 – In vitro clinical performance studies?
- It helps produce robust results. The standard helps ensure that clinical performance studies produce high quality, accurate and reliable data on the IVD medical device under investigation so that safe healthcare decisions can be made.
- It helps ensure high ethical standards. BS EN ISO 20916:2024 protects the rights, safety, dignity and well-being of subjects providing specimens for use in clinical performance studies.
- It helps with clinical performance study planning. From risk evaluation and study design to plan monitoring and labelling, BS EN ISO 20916:2024 helps ensure that studies meet regulatory and ethical requirements and use valid scientific principles.
- It helps with clinical performance study conduct. From the responsibilities of the sponsor to routine monitoring and data security, BS EN ISO 20916:2024 helps ensure studies are conducted so users can have confidence in the results.
- It helps with compliance. It provides a voluntary means for users to conform with the essential requirements of the In Vitro Diagnostic Regulation (IVDR) 2017/746.
- It clarifies roles and responsibilities. It defines the responsibilities of the sponsor and principal investigator and assists sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices.
- It strengthens risk management. Specifically, some elements of BS EN ISO 20916:2024 help ensure the safety of subjects when there’s a specimen collection risk. Also, it rigorously safeguards the integrity of data.
What is new about BS EN ISO 20916:2024?
The ISO version of this standard was published in 2019. It is now being adopted as an EN standard.
BS EN ISO 20916:2024 includes a new annex. Annex ZA has been included to cover the relationship between the standard and the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. No changes have been made to the main content of the standard.
