The Medical Devices Introductory Course 2020

EU Regulatory Approval Routes

The Organisation for Professionals in Regulatory Affairs

Non Integral Device and Drug

Regulatory pathway in the MDR MDR Art.1.9 Such devices must be CE-marked according to MDR ● The conformity assessment route choices reflect the risk class of the medical device ● Notified Body is only involved if the risk class of the device dictates it – Where a Class I device has a measuring function, is sterile or is reusable, these aspects must be overseen by a Notified Body The medicinal product is governed by Directive 2001/83/EC

The Organisation for Professionals in Regulatory Affairs