What is it? Why is it important?

The Ordinance on Clinical Trials for Medical Devices (ClinO-MD) regulates human studies aimed at evaluating the safety and performance of Medical Devices (MD).

The ordinance:

  • Provides references to ClinO for clinical study requirements
  • Defines additional requirements needed for MD studies
  • Addresses both interventional and non-interventional studies
  • Aligns with the European Medical Device Regulation (MDR)

It regulates:

  • General requirements for study conduct (e.g. SP-INV / Site-INV qualifications and obligations)
  • Documentation, notification and reporting procedures (e.g. incidents, safety protective measures)
  • EC, Swissmedic, and FOPH responsibilities (e.g. study approval, safety reporting duties)
  • Registration requirements and public access to study information (e.g. mandatory for MD studies)

More

Categorisation of MD studies:

Category A: the MD 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 when 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 MD 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)

What do I need to do?

For 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

References

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – law is available online under number

  • 810.306 ClinO-MD

ClinO-MD – see in particular articles

  • Art. 1 Subject matter
  • Art. 2 Definitions
  • Art. 3 Applicable provisions ClinO
  • Art. 6 Categorisation of clinical trials
Abbreviations
  • CTU – Clinical Trials Unit
  • CE – Conformité Européenne
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials for Medical Devices
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • KOFAM – Coordination Office for Human Research
  • MD – Medical Device
  • MDR – Medial Device Regulation
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Medical Device Ordinance ↦ In Clinical Studies
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 ↦ Medical Device Ordinance ↦ In Clinical Studies

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