What is it? Why is it important?

The Human Research Act (HRA) regulates through its ordinance on Clinical Trials with Medical Devices (ClinO-MD), studies with Medical Devices (MD). A MD tested in a study is named an Investigational MD (IMD).


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).


IMD studies are categorised as follows:

  • Category A: the IMD is authorised in Switzerland (e.g. has a CE-label), and is in accordance with the instruction for use. Further A sub-categories exist when compared with procedures applied, and if the device is used under normal conditions:
    • Category A1: Participants do not undergo additional invasive or stressful procedures
    • Category A2: Participants do undergo additional invasive or stressful procedures
  • Category C: the IMD is not authorised in Switzerland (e.g. has no CE label) or the indication differs from standardized use (risk category C is further subdivided into C1-C3)


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 of human MD studies, you are required to know and comply with requirements as defined in the ClinO-MD ordinance.

Based on your planned study:

  • Read the ClinO-MD and familiarise yourself with the organisation 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

External Links

Swissethics – see in particular

  • Templates and checklists
    • Study protocols / Studies with medical devices

Swissmedic – see in particular

  • Submission process for medical device studies
  • Adapt safety forms to safety reporting requirements for MD studies


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

ClinO-MD – see in particular articles

  • Art. 1 Subject matter
  • Art. 2 Definitions
  • Art. 3 Applicable provisions
  • Art. 6 Categorisation of clinical investigations
  • CTU – Clinical Trials Unit
  • CE – Conformité Européenne
  • ClinO-MD – Ordinance on Clinical Trials for Medical Devices
  • EU – European Union
  • KOFAM – Coordination Office for Human Research
  • MD – Medical Device
  • IMD – Investigational Medical Device
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials with Medical Device Ordinance ↦ 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 ↦ Medical Device Studies

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