The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.

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The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.
Explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.
EUDAMED UDI Compliance is a critical aspect of the European Medical Device Regulation (MDR) that requires manufacturers to adopt a standardized UDI system for better traceability and safety of medical devices within the EU market. The compliance process may seem...
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance patient safety, improve post-market surveillance, and facilitate the identification of medical devices. The UDI system requires manufacturers to assign a...
What are the potential consequences for medical device manufacturers not following through with product data submissions and labeling requirements? In a recent inspection, violations were identified regarding a manufacturer’s Unique Device Identification (UDI)...
The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID).
Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech Life Sciences at the RAPS Euro Convergence conference in Amsterdam. Upon Miriam’s return, we took some time to sit down and ask her a few questions...
Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for global health authorities and RIMS compliance platform, supports global medical device companies. LexisNexis Legal & Professional today announced,...
In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and John Lorenc (Director Product Management, Medical Devices), discuss EU EUDAMED access connection issues, who has been affected, what scenarios had...
This is a quick summary of the December 14, 2022 Emergo Webinar presented by Kenji Yashiro on the topic: Medical Device Regulatory Requirements-Japanese Guidelines Key Takeaways: This blog will cover just a few high-level takeaways from the presentation by Kenji...