The New EU Medical Device Regulation (MDR): A Project Implementation Approach

On-Demand Webinar

The new EU Medical Device Regulation (MDR) entered into force on 25 May 2017, which means the transition period from the directives has already started. The new regulation’s date of application is 26 May 2020. There are many remediation and implementation challenges and activities that must be undertaken to continue to distribute devices in the EU. As the deadline approaches, will you be compliant?

The discussion will include:

  • The compliance dates - especially the requirements due by 26 May 2020
  • Strategies for addressing and complying with this complex regulation
  • Requirements for “legacy” devices with a valid MDD/AIMD certificate
  • Requirements for class I, “new,” and devices with expired certificate
  • Live Q & A session

About the Presenters:

Jay Crowley 6Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. He was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

 

Wellington Merritt 85x105Wellington Merritt is an MDR R&D Program Manager at USDM Life Sciences. His expertise includes UDI & MDR Integration Strategy, Data Services, Visual Management, and Continuous Improvement.

 

 

 

 

 

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