Your Easy Guide to Clinical Studies

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

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

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