What is it? Why is it important?

The HRA ordinances (ClinO, ClinO-MD, HRO) define three possible risk-categories, namely A, B, or C, with category A representing a low risk and category C a high risk. Based on study type, either three, two or no category apply.

 

 

  • Based in ClinO-MD, risk-categories for Medical Device (MD) studies are either:
    • A, which are further subdivided into A1 and A2
    • C, which are further subdivided into C1, C2 and C3

 

More

Risk-categorisation of Medical Device(s) studies

Clinical investigations with MDs:

Category A

  • MD to be investigated carries a conformity marking
  • MD to be investigated is used in accordance with the instructions for use and
  • It is not prohibited to make the device to be investigated available on the market, put it into service or use it in Switzerland

Category A sub-categories

  • A1, if the participants do not undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of MD to be investigated
  • A2, if the participants undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of MD to be investigated

Category C

  • C1, if MD to be investigated carries a conformity marking, but is not used in accordance with the instructions for use
  • C2, if MD to be investigated does not carry a conformity marking or
  • C3, if it is prohibited to make MD to be investigated available on the market, put it into service or use it in Switzerland

 

Medical Device performance studies

Category A:

Sub-category A1, if

  • MD to be investigated carries a conformity marking in accordance with Article 12 IvDO
  • MD to be investigated is used in accordance with the instructions for use
  • it is not prohibited to make MD to be investigated available on the market, put it into service or use it in Switzerland,
  • None of the procedures stated in letter b point 2 are used

Sub-category A2, if

  • A non-interventional performance study that is not covered by Art. 2a paragraphs 1-3 is involved,
  • An interventional performance study in accordance with letter a points 1–3 is involved and
  • Surgically invasive procedures are used in order to collect biological material from the participants exclusively for the purpose of the performance study or
  • Participants undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of MD to be investigated

Category C:

  • If an interventional performance study is involved and
  • MD to be investigated carries a conformity marking in accordance with Article 12 IvDO, but is not used in accordance with the instructions for use (sub-category C1)
  • MD to be investigated does not carry a conformity marking in accordance with Article 12 IvDO (sub-category C2) or
  • It is prohibited to make MD to be investigated available on the market, put it into service or use it in Switzerland (sub-category C3)

What do I need to do?

As a SP-INV:

  • Select the Ordinance (e.g. ClinO, ClinO-MD or HRO) that applies to your study
  • Use the KOFAM risk-calculator to support you in defining the risk-category of your study (e.g. A has the lowest and C the highest risk)
  • If still in doubt, submit your questions to the Ethics Committee (EC) through BASEC portal. They can provide you with useful advice
  • Upon EC submission, include the defined risk-category of your study and its rational

 

The EC reviews the defined risk-category of your study, and can decide to change its category to a higher or lower risk level.

Where can I get help?

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

External Links

Swissethics – see in particular

  • BASEC: the portal for EC submission

References

KOFAM: Coordination portal for human research – see in particular 

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles and annex

  • Art. 19 Categorisation of clinical trials of medicinal products
  • Art. 20 Categorisation of clinical trials of products under Article 2a paragraph 2 TPA
  • Art. 21 Categorisation of clinical trials of transplant products
  • Art. 22 Categorisation of clinical trials of gene therapy and genetically modified or pathogenic organisms
  • Art. 49 Categorisation of clinical trials of transplantation of human organs, tissues and cells
  • Art. 61 Categorisation of other clinical studies

ClinO-MD – see in particular article

  • Art. 2 Definitions
  • Art. 6 Categorisation of clinical investigations

HRO – see in particular article

  • Art. 7 Categorisation

IvDO – see in particular

  • Art. 14 Classification
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials for Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • IvDO – Ordinance on In Vitro Diagnostic Medical Devices
  • KOFAM – Coordination Office for Human Research
  • MD – Medical Device
  • MP – Medicinal Product
  • SP-INV – Sponsor Investigator
  • TPA – Therapeutic Products Act
Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Risk Categories
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Risk Categories

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