Making Sense Of The Muddle Of EU Device Registration Timelines

23 Apr 2019

The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.

Device and diagnostics manufacturers doing business in the EU market will have to register in the Eudamed medical device database a comprehensive series of device data elements within 18 months of the full application of the Regulations (the MDR on May 26, 2020, and the IVDR on May 26, 2022).

But if there is a delay leading to the database not being ready by March 25, 2020 (the date scheduled...