On-Demand Webinar
Medical device manufacturers distributing products in Europe face a compressed timeline to comply with the European Medical Device Regulation.
To complicate matters, the requirement includes products already being distributed. For many manufacturers, there is still some uncertainty about what exactly needs to be done to comply and what data attributes need to be submitted to the EUDAMED. And, with more countries planning for their own unique device identification requirements, the challenges aren’t going away anytime soon. Watch this on-demand session to learn what steps you can take now to more easily comply with upcoming deadlines and future regulations.
What You'll Learn
- The challenges medical device manufacturers are facing as they tackle EU MDR and IVDR compliance — including products already on the market.
- The latest information on the technical specifications for the EUDAMED and which data attributes need to be submitted.
- Strategies for dealing with future global UDI (unique device identification) regulations.
- A timeline for future UDI-related regulations and how to plan ahead.
- Answers to manufacturer questions from the live Q&A.
What This Session Covers
The discussion includes:
- Challenges medical device manufacturers are facing as they tackle EU MDR and IVDR compliance
- Latest information on the technical specifications for the EUDAMED
- Strategies for dealing with future global UDI regulations
- Timeline for future UDI related regulations
- Live Q & A
Date of Application
26 May 2020 MDR
26 May 2022 IVDR
*This webinar was recorded prior to the European Commission MDR/IVDR deadline delays.
EU MDR and IVDR compliance is as much a data challenge as a regulatory one. Submitting accurate device attributes to the EUDAMED, managing UDI across a growing patchwork of global requirements, and keeping that data trustworthy over time all depend on disciplined data integrity in life sciences. USDM helps medical device manufacturers turn fragmented compliance activities into a sustained, audit-ready program rather than a one-time scramble against a deadline.
About the Presenter
Jay Crowley, Vice President, Medical Device Solutions and Services
Frequently Asked Questions About EU MDR and IVDR Compliance
Who needs to comply with EU MDR and IVDR?
Medical device manufacturers distributing products in Europe must comply with the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Importantly, the requirement applies not only to new devices but also to products already being distributed.
What is the EUDAMED and why does it matter?
The EUDAMED is the European database where manufacturers submit device data. A central compliance challenge is understanding exactly which data attributes need to be submitted and meeting the evolving technical specifications for the database. The session covers the latest information on those technical specifications.
What is UDI and why should manufacturers plan for it now?
UDI (unique device identification) is the system used to identify devices through their distribution and use. With more countries planning their own unique device identification requirements, manufacturers face a growing set of global obligations. The webinar discusses strategies for dealing with future global UDI regulations and a timeline for what's ahead so teams can plan rather than react.
When did the MDR and IVDR dates of application take effect?
The dates of application referenced in this session are 26 May 2020 for MDR and 26 May 2022 for IVDR. Note that this webinar was recorded prior to the European Commission's MDR/IVDR deadline delays, so confirm current dates against the latest official guidance.
How can USDM help with EU MDR and IVDR compliance?
USDM helps medical device manufacturers identify the steps to take now to more easily comply with upcoming deadlines and future regulations — from EUDAMED data submission and UDI strategy to building the underlying data integrity and validated systems that keep compliance sustainable. Contact us to discuss your readiness.
Watch the On-Demand Webinar
Ready to get ahead of EU MDR, IVDR, EUDAMED, and global UDI requirements? Register to watch this webinar on demand and hear practical strategies for the steps to take now. For help applying these to your own portfolio — including the validated systems and software assurance that keep device data audit-ready — contact USDM.