Is the EU MDR Extension a Blessing or a Curse? - Webinar

This webinar will help you to better understand the effects of the EU MDR extension on manufacturers, and notified bodies, how to deal with it and what medical device manufacturers must do to stay compliant.
The extension of the EU MDR deadlines from the EU Commission was received positively by the medical device industry. The extension will impact manufacturers’ preparedness towards clinical documentation, certification, and workload for notified bodies as they get closer to the extension deadlines.
The EU Commission’s MDR transitional deadlines are:
Class III custom made implantable devices - May 26, 2026
Higher Risk Class III and IIb devices - December 31, 2027
Lower Risk Class IIa and I devices - December 31, 2028
It is vital that medical device manufacturers use the extension as an opportunity and utilize this valuable time to get their certification processes within MDR regulations in order.
This featured presentation is led by Celegence’s Joseph-Richardson Larbi, Director - Medical Device Regulatory Affairs and Joy Greidanus, Director - Medical Device SME.
Webinar Focus
1. Practical aspects related to the implementation of EU MDR
2. The four criteria which must be met to qualify for an extension
3. Using the extension time wisely
Webinar Learning Objectives
1. What does the extension mean to Manufacturers?
2. What are the pitfalls to avoid during the extension?
3. Learn how notified bodies deal with the extensions - common challenges and advice.
4. What is the impact of the extension for legacy v/s new products?
5. What does this mean for Brexit? How will Switzerland act?
6. Updates; Confirmation Letter template now available from the Notified Bodies
Celegence (www.celegence....) provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers.
Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.
Our medical device expertise also includes region specific support for submissions, and global regulatory consulting and intelligence. If your team has not begun addressing any of these areas above, reach out today for a Celegence MDR Gap Analysis that will comprehensively examine all relevant aspects of your regulatory process. Reach out to us at [e-mail]!

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Your explanation of the effects of EU MDR extension are truly effective. Thanks for being such a great teacher! Liked and Subbed!