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 later 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 the next few pages, we discuss the answers to some of these questions.
Rebecca Brady, Senior Conference Producer, MedTech Summit
