The Medical Devices Introductory Course 2020

Classification of medical devices Significant MDR changes

Active Therapeutic Device with a diagnostic function MDR Annex VIII (Rule 22)

Active therapeutic devices with an integrated or incorporated diagnostic function, which significantly determines the patient management by the device are in class III, such as closed loop systems or automated external defibrillators

The Organisation for Professionals in Regulatory Affairs

MDR Scope Extension

Devices with no medical purpose – Annex XVI • Common specifications as a trigger • Covered for first time - General Safety & Performance Requirements • When used as intended should not pose any unacceptable risk to the user

The Organisation for Professionals in Regulatory Affairs