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Swissmedic has launched the UDI module in swissdamed, marking a key step in Switzerland’s medical device regulation. Voluntary submissions begin in August 2025, with mandatory registration starting July 2026. The system aligns with EUDAMED standards to enhance traceability, compliance, and post-market surveillance.
Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
Learn four strategies to simplify UDI and GSDN data management for medical device companies and ensure compliance
LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to a varied suite of regulatory compliance solutions and services to support medical device manufacturers, distributors, and related operations.
On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.
In recent news, Reed Tech became the first company to submit a device record (machine-to-machine) to the AusUDID Pre-Production system successfully.
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...