The Medical Devices Introductory Course 2020

Classification Rules - MDR

1 - 4 Non invasive devices Rule 4 also applies to invasive devices in contact with injured mucous membrane 5 - 8 Invasive devices 9 - 13 Active devices Rule 11 (New): Software (decision making for diagnosis or therapeutic purposes, monitoring of physiological parameters) from Class I to III 14 – 22 Special rules

The Organisation for Professionals in Regulatory Affairs

Classification Rules - MDR

14 – 22 Special rules 14

medicinal substance / blood derivative

15 16 17

contraception / prevention of sexual transmissible disease

disinfecting, cleaning and rinsing

recording X-ray images 18 animal & human tissue 19 Nanomaterials 20

Invasive devices with respect to body orifices to administer medicinal product via inhalation substance based intended to be introduced into human body

21

via body orifice or skin and are absorbed or locally dispersed 22 active therapeutic devices with a diagnostic function

The Organisation for Professionals in Regulatory Affairs