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The Essential Guide to Preparing Your QMS For EU MDR

You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020.

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The European Medical Device Regulation (EU MDR) has been created to replace the former Medical Device Directive (MDD) over a 3-year transition period, which comes to an end on May 26, 2020. These new requirements involve several changes that medical device companies must be prepared for, including things like device classification and updating your QMS.

We will cover some of the most important action items that must be taken ASAP by companies.

  • Understand the key changes in the MDR

  • Documentation and requirements for each category of Economic Operators within the supply chain

  • Updates to comply with SPRs

  • Incorporating UDI and EUDAMED into your labeling and traceability SOPs

  • Procedures for the regulatory compliance strategy

  • New requirements for Implantable devices

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