On-Demand Webinar
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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What you'll learn
- The near-term requirements that apply to Directive (MDD/AIMD), Legacy, and Regulation devices placed on the EU market.
- What manufacturers must do before the Date of Application — and which devices have no additional transition period.
- How MDD/AIMD-compliant devices can continue to be marketed until their certificates expire, and the additional MDR obligations they must still meet.
- The role and timing of the European Database on Medical Devices (EUDAMED), and why Competent Authorities interpret its delay differently.
- How the transitional periods running through 27 May 2025 reshape your compliance roadmap.
Why EU MDR Date of Application Readiness Matters
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.
USDM's point of view: EU MDR readiness is not a single deadline — it's a sequence of overlapping transitional obligations that touch device classification, certificate timelines, and EUDAMED submissions at once. The technical documentation, post-market surveillance, and data submissions behind MDR depend on validated, trustworthy systems. Treating MDR as a continuous-compliance program — with strong data integrity in life sciences and a defensible computer software assurance approach — keeps you audit-ready as each transitional milestone arrives rather than scrambling at each one.
Webinar Video
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
- Q&A
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. Download the white paper: EU MDR Date of Application Readiness Guide today!
FAQ: EU MDR Date of Application Readiness
What is the EU MDR Date of Application (DoA)?
The Date of Application is the point — 26 May 2021 — from which any medical device (and some non-devices) placed on the EU market must comply with the new EU MDR. It marks the end of the transition period from the MDR's original enactment on 5 April 2017 and the start of a series of transitional periods that run until 27 May 2025.
Can devices certified under the old Directives still be sold after the DoA?
Most Directive (MDD/AIMD)-compliant devices can continue to be placed on the market until their certificates expire, but they must meet a series of additional MDR requirements. Some devices have no additional transition period and must be MDR compliant before being placed on the EU market after 26 May 2021.
What is EUDAMED and how does its delay affect manufacturers?
EUDAMED is the European Database on Medical Devices. Development of the database and the required submission of various information was delayed until at least 26 May 2022, and various Competent Authorities are interpreting that delay differently — so manufacturers should confirm expectations in the markets where they operate.
How does this webinar help me prepare?
The on-demand session walks through near-term requirements for Directive, Legacy, and Regulation devices, what you must do before the DoA, and the role and timing of EUDAMED. The companion EU MDR DoA Readiness Guide adds detail on the transitional period and the end of Legacy devices in 2024.
How can USDM support EU MDR readiness?
USDM helps medical device organizations operationalize MDR obligations through validated systems and continuous compliance — including electronic records and signatures compliance and ongoing validation under USDM Cloud Assurance so your quality and technical-documentation systems stay audit-ready across each transitional deadline.
About the Presenter
Jay Crowley, Vice President of Medical Device Solutions and Services
Watch the on-demand webinar. Fill out the form above and click Watch Now to view the full session. Want to talk through your EU MDR roadmap with our medical device team? Contact USDM.