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Certification Application

Wednesday, April 23rd

News

Upcoming Key Dates for IVD Manufacturers in 2025

In this video, Tom Patten, GMED International IVDR Manager, covers some of the upcoming crucial dates for IVD manufacturers, including:

May 26, 2025

Class D: Formal application with a Notified Body
All Classes: Valid QMS compliant with IVDR
Class B & C: IVDR UDI labeling requirements

September 26, 2025

Written agreements with Notified Bodies required
Transition details for appropriate surveillance

For more details, check out the video and feel free to reach out with any questions:

Book a meeting with Tom: Schedule here
Or contact us: info@lne-gmed.com

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Let’s ensure compliance and stay ahead in 2025