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 (IVD) 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 (e.g. data quality)
  • Protect the rights, safety and well-being of the human research participants

What do I need to do?

When planning IVD MD studies, 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 the intervention know what risk-category applies to your study (e.g. category A with low risk and category C with high risk)


ISO standards are liable to costs; you must therefore purchase the ISO standards.

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 Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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