Learn about in vitro diagnostic (IVD) medical devices

In vitro diagnostic (IVD) medical devices are:

• a type of medical device
• used outside the human body.

We use the term ‘in vitro’ to mean testing of a human sample outside the body.

IVDs are used:

• to give information about a physiological or pathological state
• to monitor therapeutic measures (for example, medicine or biomarker levels in a patient)
• for screening for diseases, conditions, and ailments
• to assist health professionals in:
  • making a clinical diagnosis
  • making decisions for clinical management
  • determining the safety and compatibility of therapeutic goods with a potential recipient.

IVDs are used by:

• health professionals:
  • at a laboratory
  • at point of care (near patient) testing
• the general public.

Example IVDs

• pregnancy test kit
• blood glucose meter and test strips
• COVID-19 test
• software for identifying abnormal cells in a sample
• laboratory developed test (in-house IVD) for genetic testing 

Common forms of IVDs

• reagents
• calibrators
• control materials
• kits
• specimen receptacles
• software (including mobile apps)
• instruments
• apparatus.