MDR Delay Due to COVID-19 Pandemic

4/01/2020

medical device clinical research

Because of the COVID-19 pandemic, the European Commission announced that the implementation of the Medical Devices Regulation (MDR) will likely be delayed by one year. There are limited resources currently available to implement the MDR by the original date of May 26, 2020. The MDR was adopted in April 2017 and will replace the Medical Devices Directive (MDD) when implemented. Medical devices have become more complex, and the purpose of the MDR is to modernize medical device regulations in the European Union. One key change with the MDR that is most impactful in the current landscape of COVID-19 resource scarcity is that the MDR requires all currently approved devices to be recertified. The one year delay is thought to allow manufacturers to focus on supporting efforts to eradicate COVID-19 before focusing on recertifying medical devices.

- The Clinical Pathways Team

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