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.

The aim is to assess the safety and performance 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
• Define SP-INV responsibilities
• Assist marketing holder, SP-INV / Site-INV, the EC/RA and other bodies regarding MD conformity assessments

ISO 14155 does not apply to in vitro diagnostics. Studies with in vitro diagnostics are regulated in ISO 209106.

When planning MD studies involving humans, 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)

References

KOFAM: Coordination portal for human research – see in particular

• Online wizard for risk categorisation

ISO 14155:2020 Medical device (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