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

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 Jimarc, Thu, Aug 15, 2019
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