What is it? Why is it important?
In-Vitro-Diagnostic (IVD) MedicalDevices (MD) are tests used on biological material (e.g. blood, tissue, saliva) to determine and diagnose a person’s health status.
Study set-up and type will decide the risk-category of the study (e.g. risk-categories A or C apply, with A having the lowest and C the highest risk).
Risk-ategory A: the IVD product bears a conformity marking (CE) and is used in accordance with instructions
The in IVD product:
- Does not have a conformity marking (CE)
- Bears the CE marking but is not used in accordance with:
- The intended purposes recognized in the conformity assessment, and
- Is prohibited in Switzerland
The CE (Conformité Européenne) mark:
- Is the European Union’s (EU) mandatory conformity marking for regulating products sold within the EU
- Shows that the manufacturer has checked and ensures that the product meets EU safety, health, or environmental requirements
What do I need to do?
Based on the risk-category of your study, submit your application dossier to:
- The Ethics Committee (e.g. EC, application dossier) who grants authorisation of risk-category A and C studies.
- The Swissmedic (e.g. application dossier) who grants authorisation of risk-category C studies
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
Swissethics - see in particular
- Template for an IVD medical device Clinical Performance Study Plan (CPSP)
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
ClinO-MD – see in particular articles
- Art. 1.a Subject matter
IvDO – Ordinance on In-Vitro diagnostic medical devices