The Medical Devices Introductory Course 2020

What is a combination product ?

The Organisation for Professionals in Regulatory Affairs

What is a Combination product ?

• Medicinal Product containing a mixture of different APIs? • Product containing a combination of different technologies? • FDA have a definition as per CFR 21 3.2 (e) • Not defined in the EU and no such definition exists

The focus for todays session is the combination of a drug with a medical device

The Organisation for Professionals in Regulatory Affairs