What is it? Why is it important?

The Human Research Act (HRA) regulates through its ordinance on Clinical Trials with Medical Devices (ClinO-MD):

  • Requirements for studies with:
    • Medical Devices (MD) and other devices in accordance with article 1 of the MedDO (July 2020)
    • In-vitro-Diagnostic MD and their accessories in accordance with article 1 paragraph 1 of the IvDO (May 2022)
  • Approval (e.g. Ethics Committee (EC), regulatory authorities such as Swissmedic, and if applicable the Federal Office of Public Health (FOPH)) and reporting procedures (e.g. safety reporting, amendments, study termination)
  • Duties and responsibilities of EC, Swissmedic and the FOPH
  • Registration requirements
  • Public access to information

What do I need to do?

As a SP-INV and depending on your planned study make yourself familiar with:

  • The different ordinances and laws applicable to your Medical Device study such as the ClinO-MD, MedDO, ClinO (e.g. includes a radiation source, or a combination of an IMP and MD), IvDO ordinances, and the Radiological Protection Act (RPA)
  • ISO 14155 which defines ethical and scientific quality standards for designing, conducting, recording and reporting of Medical Device studies, or
  • ISO 20916 which defines ethical and scientific quality standards for the designing, conducting, recording, and reporting of studies evaluating clinical performance In-Vitro-Diagnostic (IVD) Medical Devices (MD)
  • Medical Device submission and approval requirements (e.g. EC, Swissmedic (e.g. for risk-category C studies), and the FOPH). An EC and Swissmedic submission are done in parallel

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
  • Clinical trial with medical devices according to ClinO-MD
  • Overview of safety reporting in clinical trials of medical devices
  • Clinical trials with medical devices: Expected changes on the legal requirements and BASEC

Swissmedic – see in particular

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

References

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

MedDO – see in particular

  • Art. 1 Scope

RPA – see in particular article

  • Art. 28 Mandatory licencing

IvDO – see in particular

  • Art. 1 Scope
Abbreviations
  • BASEC – the portal for EC submission
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • IMP – Investigational Medicinal Product
  • IvDO -  Ordinance on In Vitro Diagnostic Medical Devices 
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • MedDO – Medical Devices Ordinance
  • RPA – Radiological Protection Act
Basic ↦ Ethics and Laws ↦ Clinical Trials with Medical Device Ordinance ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Clinical Trials with Medical Device Ordinance ↦ Aim

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