Was betrifft es? Warum ist das wichtig?

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.

Mehr

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)

Was muss ich befolgen?

As a SP-INV / Site-INV familiarize yourself with the IVD-MD definition.

 

Note: The “Drug & Device” section addresses Medicinal Products and Medical Devices. Apart from the definition of “In Vitro Medical Devices”, the Easy-GCS does not further cover studies with IVD-MDs.

Wo kann ich Hilfe anfordern?

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
Abkürzungen
  • ClinO-MD CTU – Ordinance on Clinical Trials of Medical Devices
  • CTU – Clinical Trials Unit
  • HCV – Hepatitis C Virus
  • HIV – Human Immunodeficiency Virus
  • IVD-MD – In Vitro Diagnostic Medical Device
  • IvDO – Ordinance
  • on In Vitro Diagnostic Medical Devices
  • MD – Medical Device
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • TPA - Therapeutic Products Act
Basic ↦ Drug or Device ↦ In Vitro Diagnostic Device ↦ Definition
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
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 Drug or Device
Current Path (click to copy): Basic ↦ Drug or Device ↦ In Vitro Diagnostic Device ↦ Definition

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