Your Easy Guide to Clinical Studies

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

 

The ISO 14155 defines ethical and scientific quality standards for the designing, conducting, recording and reporting of Medical Device (MD) studies (ClinO-MD).

 

The aim is to assess the safety and performance (e.g. quality assurance) of MDs in human studies.

 

General requirements include to:

• Protect the rights, safety and well-being of human study participants
• Ensure good scientific conduct and the credibility of study results (e.g. data quality)
• Define SP-INV responsibilities

 

ISO 14155 does not apply to In-Vitro Diagnostics (IVD). IDV studies are regulated in ISO 20916.

As a SP-INV planning a MD study, you are required to know and adhere to requirements defined in the ISO 14155:

• Obtain and file a copy of the ISO standard in the TMF/ISF of your study (e.g. access liable to costs)
• 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

HumRes: Coordination portal for human research in Switzerland

ISO 14155:2020 – Medical Device Clinical Studies (access liable to costs)

SNV Standards that connect the world

• Shop for the purchasing of ISO standards

MDCG – see in particular

• Main page that provides guidance and documents for EU medical device applications