Basic↦Drug or Device↦In Vitro Diagnostic Device↦Definition
What is it? Why is it important?
An In-Vitro-Diagnostic Medical Device (IVD-MD) is a product used to;
- Detect/diagnose diseases (e.g. rheumatic diseases), infections (e.g. HIV, HCV), and other conditions (e.g. blood hormone levels)
- Monitor a person’s health in order to cure, treat, prevent disease or its consequences (e.g. monitoring of blood glucose levels in diabetic patients)
IVD-MD tests:
- Are performed in vitro (e.g. in a clinical setting outside a living organism such as in a test tube)
- Use biological test materials such as blood, urine, tissue samples, but also materials such as saliva, faeces, sperm, etc.
- Are diagnostic tools used in the implementation of clinical studies. Leftover biological material can be used in further-use studies
An IVD-MD is used alone (e.g. pregnancy test) or in combination with other IVD-MD tools (e.g. insulin pump with a blood sugar meter).
Manufacturers domiciled in Switzerland are obliged to notify Swissmedic when placing IVDs on the Swiss market for the first time.
More
IVD include devices such as:
- Reagent and reagent product (e.g. a substance or mixture used as an integral part of a chemical reaction, such as a pregnancy or blood glucose test)
- Calibrators (e.g. devices used to adjust the accuracy of an instrument, such as a temperature or pressure calibrator)
- Control material: Such as a positive and negative control. If the positive and negative control are displayed correctly, It ensures that the test always finds what it is supposed to find and does not incorrectly detect something if there is nothing to find.
- Diagnostic kits (e.g. pregnancy, HIV)
- Apparatus (e.g. a machine used for a specific purpose, such as a blood pressure monitor)
- Piece of equipment
- Software or system used alone or in combination to be used in vitro for the examination of biological material (e.g. specimens, including blood and tissue donations, derived from the human body)
What do I need to do?
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissmedic – see in particular
- Medical Device / market access / Notification of IVDs
- Services & lists / Events / Archive / New regulations on in vitro diagnostic medical devices
Swiss Law
IvDO – see in particular articles
- Art. 1 Scope
- Art. 3 In vitro diagnostic medical device and its accessories
TPA – see in particular articles
- Art. 4 Medical Device (MD) definition
- Art. 47e - b) Federal council additional obligations
ClinO-MD – see in particular article
- Art. 1a paragraph 2: the ordinance regulates clinical trials of IVD-MDs