The Medical Devices Introductory Course 2020

Examples of products regulated as a medical device (Device-Drug)

The Organisation for Professionals in Regulatory Affairs

Examples of products regulated as a medicinal product (Drug- Device)

Prefilled syringes/pens Pre-charged nebulizers Patches for transdermal drug delivery Aerosols containing a medicinal substance Implants that release a medicinal product

Article 117 of MDR has amended the MPD 2001/83/EEC and has impacts for the assessment of these types of products

The Organisation for Professionals in Regulatory Affairs