EMA Publishes Q&A on MDR/IVDR Regulations

November 15, 2019

The European Medicines Agency released a new question and answers document on its Medical Devices Regulation and In Vitro Diagnostic Regulation in an attempt to answer mounting questions from industry.

The agency released a similar document early in the year, but the new Q&A provides more details on how the new regulations will be implemented starting May 26, 2020 for devices and May 26, 2022 for IVDs.

The new Q&A adds information on how combination products will be regulated and which EMA division will review certain combination products, as well as the process for selecting notified bodies, and how the new regulations will affect mutual recognition procedures and timelines for changes to devices.

View today's stories