The Medical Devices Introductory Course 2020

Classification of medical devices Classification Criteria

Degree of Invasiveness (2) Reusable surgical instrument

an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which are intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out

The Organisation for Professionals in Regulatory Affairs

Classification Rules - MDD

1 - 4

Non invasive devices

5 - 8

Invasive devices

9 - 12

Active devices

13 - 18 Special rules

13: medicinal substance / human blood derivative 14: contraception / prevention of sexual transmissible disease 15: disinfecting, cleaning and rinsing 16: recording X-ray images 17: animal tissue 18: blood bags

The Organisation for Professionals in Regulatory Affairs