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 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
- Defining marketing holder, SP-INV responsibilities
- Assist marketing holder, SP-INV, EC/RA in evaluating conformity of the in vitro diagnostic MD
- Protect the rights, safety and well-being of the human research participants
What do I need to do?
When planning studies of in vitro diagnostic MDs involving humans, 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 your study and intervention know how to risk classify your study
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
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