What is it? Why is it important?
The Human Research Act (HRA) regulates through its ordinance on Clinical Trials with Medical Devices (ClinO-MD), studies with Medical Devices (MD). A MD tested in a study is named an Investigational MD (IMD).
Study set-up and type will decide the risk-category of the study (e.g. risk-categories A or C apply, with A having the lowest and C the highest risk).
IMD studies are categorised as follows:
- Category A: the IMD 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, and if 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 IMD 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)
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
What do I need to do?
As a SP-INV of 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Swissethics – see in particular
- Templates and checklists
- Study protocols / Studies with medical devices
Swissmedic – see in particular
- Submission process for medical device studies
- Adapt safety forms to safety reporting requirements for MD studies
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
ClinO-MD – see in particular articles
- Art. 1 Subject matter
- Art. 2 Definitions
- Art. 3 Applicable provisions
- Art. 6 Categorisation of clinical investigations