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Regulatory Affairs, Medical Devices

The Journey to EU MDR Implementation - MedTech eBook Series

Posted by on 30 March 2021
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In the latest edition of the MedTech Summit eBook Series, we answer some of the questions around implementation of the EU MDR on 26 May and beyond. Read the full eBook by clicking on the image above (or here). Rebecca Brady, Senior Conference Producer, MedTech Summit, introduces it:

"The journey to EU MDR implementation has been far from smooth, with the Date of Application being shifted by a year due to the global COVID-19 pandemic, delays to EUDAMED and still many lingering questions surrounding the requirements for compliance. Despite the challenges, the Medical Device industry has worked tirelessly through it all to meet the requirements of the EU MDR and be ready for May 2021.

However, the 26th May is not the finish line. We can’t tick EU MDR compliance off the list and move on. As Donna Occhipinti says in this eBook, the EU MDR is a “paradigm shift”; it will affect future resources, the continued status of your CE mark and staying global.

With just a few months to go, the inevitable questions regarding life after the DoA begin to creep in. What will regulating medical devices under the EU MDR look like in reality? What does it really mean to be a Person Responsible for Regulatory Compliance? How will applications work without EUDAMED?

In this edition of the MedTech eBook Series, we discuss the answers to some of these questions."

The eBook features the following:

  • EU MDR and Beyond: The balancing act between innovation and compliance: By Annemien Pullen, PhD, Director Strategy, Veeva MedTech Europe.
  • Clinical expectations of the EU MDR: ​​​​​Matthias Fink from TÜV SÜD, and Dona Occhipinti from MedSmart discuss in this exclusive video interview.
  • Your Questions Answered: Understanding the role of Person Responsible for Regulatory Compliance: TEAM-PRRC EU Association President Elem Ayne and Vice-President Anne Jury answer your questions on PRRC
  • How the changing EUDAMED timeline impacts implementation of the EU MDR: Interview with Richard Houlihan, CEO of Eudamed.EU
  • No EUDAMED, No Problem! Latest Guidance Explains Alternatives While Database Is Built: By Amanda Maxwell, European Regulatory Affairs Editor, Medtech Insight

Read the full eBook by clicking on the image at the top of this page or here.

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