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.


The Human Research Act (HRA) regulates through its Clinical Trials with Medical Devices Ordinance (ClinO-MD), studies with IDV and its accessories.


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


Risk-ategory C:

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
    • Instructions
  • 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?

As a SP-INV planning a study with an IVD and its accessories, you are required to know and comply with the requirements defined in the ClinO-MD ordinance.


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


A Swissmedic submission and an EC submission must be done in parallel.

Where can I get help?

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


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

Swiss Law

ClinO-MD – see in particular articles

  • Art. 1.a Subject matter

IvDO – Ordinance on In-Vitro diagnostic medical devices

  • ClinO – Clinical Trials Ordinance
  • CE – Conformité Européenne
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EU – European Union
  • HRA – Human Research Act
  • IVD – In Vitro Diagnostic
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials with Medical Device Ordinance ↦ In Vitro Diagnostic Medical Device Studies

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Clinical Trials with Medical Device Ordinance ↦ In Vitro Diagnostic Medical Device Studies

Please note: the Easy-GCS tool is currently under construction.