Module 18 2021

06/02/2021

3

Medical devices are typically used on or in humans

The Organisation for Professionals in Regulatory Affairs

3

Human body

Medical evaluation

Take a sample

Testing outside of the human body

Anamnesis Info

IVD

Imaging Info

Information

Endoscopic Info

Using a Medical Device

Other Info

IVD 1 IVD 2 IVD 3 IVD 4

Information

Specimens are never reintroduced into the human body

Information

Information

Information

Using an IVD

Diagnosis/ treatment decisions

4

In vitro diagnostic medical devices

The Organisation for Professionals in Regulatory Affairs

4

2