The Medical Devices Introductory Course 2020

Classification

Classification Rules based on risk factors such as: ● invasiveness and implantation ● duration of use (transient, short, long term) ● supply or use of energy / power (‘active’ / ‘non-active’)

● site of use (high risk: central circulatory and central nervous systems) ● special rules (for drug-device combinations, contraceptive devices, cleaning devices, animal derived materials, blood bags) ● highest classification applies if several rules apply

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs