Frequent European Issues identified in customs or by competent authorities
We at Emergo by UL have seen an increase in labeling issues since the Date of Application (DoA) for the Regulations, Medical Device Regulation (2017/745, MDR) and In Vitro Diagnostic Device Regulation (2017/746, IVDR). The issues are identified during customs review which delays shipments of medical devices to intended recipients.
Brazil ANVISA Announces Priorities for the 2024-2025 Year
Brazil’s medical device market regulator, ANVISA, announced its priorities in the “Regulatory Agenda” for the 2024-2025 year.
The European Proposal to Delay Compliance for Legacy IVDs and EUDAMED Rollout
The EC proposed a delay to compliance of legacy IVDs and for EUDAMED to be phased in.
Switzerland Update: Swissmedic Medical Device Database Release Delay
Medical device regulator Swissmedic updated the release schedule for the swissdamed database.
U.S. FDA IVD Reclassification Announcement for Laboratory Developed Tests
In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a specific type of premarket submission type, based on risk.
US FDA Breakthrough Device (BTD) and Safer Technologies Program (STeP) Designations
Our Emergo by UL expert discusses Breakthrough Device (BTD) and Safer Technologies Program (STeP) designations in this on-demand webinar.
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Recent Brazil Regulatory Updates
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights into Brazil’s regulatory updates.
Malaysia MDA Publishes Harmonized Guidance on Post-Market Surveillance Information Exchange for ASEAN Member States
The Malaysia Medical Device Authority released the first edition of its harmonized guidance document on post-market data exchange between ASEAN member states.
New MDCG Device Specific Vigilance Guidance Documents Published
The Medical Device Coordination Group (MDCG) published several updated Device Specific Vigilance Guidance (DSVG) documents on January 30.