What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies with in Vitro Diagnostic Medical Devices (Vitro-D-MD) and products.

Based on the study risk, categories A or C apply, with A having the lowest and C the highest risk.

Category A: the in Vitro-D-MD and product bears a conformity marking (CE) and is used in accordance with instructions

Category C:

The in Vitro-D-MD and product:

  • Does not have a conformity marking (CE)
  • 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

For combinations of IMP and in Vitro-D-MD, refer to medicinal products

What do I need to do?

For studies with an in Vitro-D-MD or product, you are required to know and comply with the requirements defined in the ClinO ordinance:

  • Familiarise yourself with the organisation of the various chapters and sections
  • Focus on the articles that are relevant to your study

Based on the risk category, submit your application dossier to:

  • EC who grants authorisation of category A, B, and C studies and provides a first reply within:
    • 30 days for monocentric studies
    • 45 days for multi-centre studies
  • Swissmedic who grants authorisation of category B and C studies and provides a first reply within:
    • 30 days
    • A potential additional 30 days for first in human studies, or for in vitro diagnostic MDs manufactured in a new process
    • Category A studies are exempt from Swissmedic authorisation

Where can I get help?

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

References

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular articles

  • Art. 20 Categorisation of studies of in vitro diagnostic MD and products
  • Art. 26 Procedures and deadlines EC
  • Art. 27 Procedures and deadlines EC in multicentre clinical trials
  • Art. 33 Procedures and deadlines Swissmedic
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CE – Conformité Européenne
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EU – European Union
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • IMP – Investigational Medicinal Product
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • Vitro-D-MD – In Vitro Diagnostic Medical Device
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ In Vitro Diagnostic Medical Device
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 ↦ Clinical Trials Ordinance ↦ In Vitro Diagnostic Medical Device

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