What is it? Why is it important?

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.

What do I need to do?

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)

Where can I get help?

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

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
Abbreviations
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • ISO – International Organization for Standardization
  • KOFAM – Coordination Office for Human Research
  • MD – Medical Device
  • MDCG – Medical Device Coordination Group
  • Site-INV – Site Investigator
  • SNV – Schweizerische Normen Vereinigung
  • SP-INV – Sponsor Investigator
  • TMF/ISF – Trial Master File / Site Investigator File
Basic ↦ Ethics and Laws ↦ Guidelines ↦ ISO 14155
Study
Basic

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

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
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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
Completion

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 14155

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