The Medical Devices Introductory Course 2020

What is meant by Integral

A medical device incorporates a medicinal substance as an integral part, if and only if the device and the substance are physically or chemically combined at the time of administration (i.e. use, implantation, application etc) to the patient.

The Organisation for Professionals in Regulatory Affairs

What is meant by ancillary

Action from the Medicinal Substance

Action from the Device Component

The Organisation for Professionals in Regulatory Affairs