Learn some near-term and long-term strategies you can use when addressing Medical Device Regulation (MDR) Date of Application (DoA).
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As of 26 May 2021, any medical device (and some non-devices) placed on the market in the European Union (EU) must be compliant with the new EU MDR. This 2021 deadline is a one-year delay of the original MDR DoA. The DoA is also the end of the transition period from the original enactment of the MDR on 5 April 2017 and the beginning of a series of transitional periods that will run until 27 May 2025.
Most Directive (MDD/AIMD)-compliant devices can continue to be placed on the market until their certificates expire; however, there are a series of additional MDR requirements that these devices must meet. Some devices have no additional transition period and must be MDR compliant before being placed on the EU market after 26 May 2021.
At the same time, the development of the European Database on Medical Devices (EUDAMED) and the required submission of various information has been delayed until (at least) 26 May 2022, and various Competent Authorities are interpreting this delay differently.
Webinar Sneak Peek
This discussion also included:
- Near-term requirements for Directive, Legacy, and Regulation Devices
- What you must do before the DoA
- The role and timing of EUDAMED
EU MDR DoA Readiness Guide
The purpose of this guide is to help you confidently achieve DoA readiness and adhere to deadlines beyond the DoA. We’ll share information about the transitional period we are in (from 26 May 2021 to 27 May 2024), and the end of Legacy devices in 2024. Click here to download.
About the Presenter
Jay Crowley, Vice President of Medical Device Solutions and Services