EUDAMED UDI Compliance is a critical aspect of the European Medical Device Regulation (MDR) that requires...
Embracing EUDAMED UDI Compliance Timing: Why Starting the Process Now is Crucial for Medical Device Manufacturers
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Recent Blogs
Understanding FDA Exemptions to Unique Device Identification (UDI) Requirements
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance...
Understanding FDA UDI Compliance Requirements for Medical Device Manufacturers
What are the potential consequences for medical device manufacturers not following through with product data...
Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID
Courtesy notification of news from FDA: The U.S. Food and Drug Administration (FDA) recently initiated two initiatives...
Reed Tech Takeaways from RAPS Euro Convergence
Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech...
LexisNexis Reed Tech teams up with RegDesk, a leading regulatory information management platform
Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for...
EU Amendment to Extend Legacy Medical Device Transition
In recent news, the European Commission passed an extension (EU Regulation 2023/607) to the transition deadline for...
Coffee Talk with Reed Tech – EU EUDAMED Testing Update
In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and...
Simplifying Annual Drug Sample Reporting
Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.