The Medical Devices Introductory Course 2020

IVDs

Medical devices are usually used directly on/in the patient In vitro diagnostic medical devices are used to perform a diagnosis based on a sample taken from the patient • Pregnancy tests • HIV tests • Glucose measuring device • IVDs do not usually touch the patient

IVD Directive 98/79/EEC – Classification is List based

IVDR – Risk Classification introduced

The Organisation for Professionals in Regulatory Affairs

Classification of Medical devices

Classification in the MDD and MDR MDD Art.9, MDR Art.51 • Class III - highest risk • Class IIb - medium to high risk • Class IIa - medium risk • Class I - lowest risk including measuring, sterile and reusable surgical instruments Im, Is & Ir

Risk classification is based on the manufacturer’s intended purpose

The Organisation for Professionals in Regulatory Affairs