EU Medical Device Regulation (MDR) with far-reaching impact for device manufacturers doing business in Europe

15 August 2019

The EU Medical Device Regulation is scheduled to take effect May 26, 2020.

A few important requirements to note: Device manufacturers will be required to have risk management and quality management systems in place Manufacturers must continue collecting clinical evidence for all devices once they are on the market to demonstrate their safety and effectiveness Manufacturers must report data on a new centralized electronic system, and the data will be made publicly available Manufacturers are responsible for determining which devices will be reclassified and which will need further review by a notified body Manufacturers must have systems in place to cover their financial responsibility for harm caused by defective devices
Author(s)	Source
Lehmann J	imarc, Thu, Aug 15, 2019
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