Your Easy Guide to Clinical Studies

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

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.

References

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)

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