All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)

Medical Device made Easy Podcast · Mar 23, 2020

We already talked on the podcast about the class I devices. But here I wanted to focus more on the sub-classes of class I products. There are 3 sub-classes which are Class I sterile (Is), Class I with a measuring function (Im) and the new Class I for surgical reusable devices (Ir). When class I products are Self-Certified, you should know that this is not the case for class I special devices.

Elem Ayne from ACR Medical will help us understand the difference and what should be done to have compliant medical devices. She will also tell you what will be checked during an audit. This part is…