MDR certification: IMAGE already submitted application for iQ-SYSTEM PACS

Since May 26, 2021, all companies that want to place medical devices on the European market must comply with the requirements of the new Medical Device Regulation (MDR (EU) 2017/745). 

This means that they must hold an MDR certificate for the respective products by the time the formerly issued MDD certificate becomes invalid.

There is still a transitional period of two years until IMAGE’s current MDD certificate (94/42/EEC) expires on May 27, 2024. However, IMAGE has already taken the necessary steps to prepare for this change and successfully submitted the application to get iQ-SYSTEM PACS MDR-certified. Due to the high demand of MDR audits these days and our Notified Body’s tight agenda, we can only roughly estimate to receive our MDR certification anytime in 2023. We will keep you posted.