What is it? Why is it important?

The International Organisation for Standardisation (ISO) is an independent, non-governmental international organisation.

The ISO 20916 defines ethical and scientific quality standards for the designing, conducting, recording, and reporting of studies evaluating clinical performance of in vitro diagnostic Medical Devices (MD).

The aim is to provide principles supporting studies on clinical performances and provides requirements on:

  • Ensuring that study conduct will provide reliable and robust data
  • Defining marketing holder, SP-INV responsibilities
  • Assist marketing holder, SP-INV, EC/RA in evaluating conformity of the in vitro diagnostic MD
  • Protect the rights, safety and well-being of the human research participants

What do I need to do?

When planning studies of in vitro diagnostic MDs involving humans, you are required to know and adhere to requirements defined in the ISO 20916:

  • Obtain and file a copy of the ISO standard in the TMF/ISF of your study (access liable to costs; personalized licence)
  • Familiarise yourself with the organization of the various chapters and sections
  • Focus on the articles that are relevant to your study. Tag them in order to ensure compliance
  • Based on your study and intervention know how to risk classify your study

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

ISO 20916:2019 In vitro diagnostic medical devices (access liable to costs)

SNV Standards that connect the world

  • Shop for the purchasing of ISO standards
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • ISO – International Organization for Standardization
  • KOFAM – Coordination Office for Human Research
  • MD – Medical Device
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • SNV – Schweizerische Normen Vereinigung
  • TMF/ISF – Trial Master File / Site Investigator File
Basic ↦ Ethics and Laws ↦ Guidelines ↦ ISO 20916

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Set-Up Biobanking

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Guidelines ↦ ISO 20916

Please note: the Easy-GCS tool is currently under construction.